To be sure, Thursday is proving to be a good day for most ASX shares.

The All Ordinaries Index (ASX: XAO) is up 1.5% at the time of writing as easing inflation in the United States and rising unemployment in Australia increase the odds of central bank interest rate cuts (details here).

But this ASX healthcare stock is leaving those gains in the dust.

Shares in the company, which specialises in medical devices, closed up 3.9% yesterday at 2.7 cents. In earlier trade today, shares were swapping hands for 4.4 cents apiece, up an eye-watering 63.0%.

After some likely profit-taking, shares are currently trading for 3.2 cents apiece, up 18.5%.

Any guesses?

If you said Atomo Diagnostics Ltd (ASX: AT1), go to the head of the virtual class.

Here's why the Atomo Diagnostics share price is rocketing today.

ASX healthcare stock lifts off on Federal budget news

The Atomo Diagnostics share price is soaring after the company lauded the new Federal budget's commitment to fund the expansion of HIV self-testing.

That's important for shareholders, as the ASX health care stock supplies the only HIV self-test that's included on the Australian Register of Therapeutic Goods (ARTG).

Management noted the key role the company has played in implementing the pilot programs, which will now be scaled up nationally with government funding support.

Atomo shares are surging, and the company says it anticipates that "a significant portion of the funding committed to these expanded HIV self-test programs" will be used to buy its HIV tests.

The ASX healthcare stock highlighted that under the new Federal budget:

• People with or at risk of HIV will receive unprecedented support ($43.9 million) through better prevention, testing, workforce training and information, with the government committed to eliminating HIV transmission by 2030.
• More people in at-risk groups will get free HIV self-test kits through the expanded national HIV self-test mail-out program.
• And people around Australia will get wider access to HIV testing by extending the South Australia-based HIV testing vending machine pilot to every state and territory.

What did management say?

Commenting on the new funding that's sending the ASX healthcare stock soaring today, Atomo CEO John Kelly said:

We are delighted to see the government recognise the critical need to ensure HIV self-test availability across the community and fund the rapid expansion of the national HIV self-test mail-out program and the HIV self-test vending machine pilots.

Both have proven extremely successful in increasing testing rates among groups not currently testing via healthcare facility-based services.

With today's intraday moves factored in, the ASX healthcare stock is up 60% year to date.

The post Guess which ASX healthcare stock just exploded 63% on Federal budget funding news! appeared first on The Motley Fool Australia.

Very high.

Shares in the medical device company closed yesterday trading for 2.7 cents. In morning trade on Wednesday, the ASX pharmaceutical stock leapt to 6.0 cents per share, up a whopping 122%.

After some likely profit-taking, at the time of writing shares are trading for 4.4 cents apiece, up a very healthy 63.0%.

For some context, the All Ordinaries Index (ASX: XAO) is down 0.3% at this same time.

Any guesses?

If you said Atomo Diagnostics Ltd (ASX: AT1), give yourself a virtual gold star.

Here's what's piquing investor interest in the microcap stock today.

What's sending the ASX pharmaceutical stock soaring?

The Atomo Diagnostics share price is rocketing higher after the company announced it had secured purchase orders from Viatris Healthcare for around $970,000 worth of HIV Self-Tests.

The test kits, manufactured by the ASX pharmaceutical stock under the Mylan brand, will be used to supply a number of low and middle income countries (LMICs).

The orders are for manufacture during the second half of FY 2024.

"We have seen growing demand during FY24 for the Atomo HIV Self-Test here in Australia as well as across branded versions supplied to international markets," Atomo CEO John Kelly said.

"Following significant increases in sales to Europe and in Australia, it is good to now see emergent demand across LMIC markets from our global health partner for HIV testing, Viatris," Kelly added.

The ASX pharmaceutical stock has commercialised a number of products across international markets. It has existing supply agreements for testing applications targeting infectious diseases including COVID-19, HIV, viral versus bacterial differentiation and female health.

The post Guess which ASX pharmaceutical stock just rocketed 122%! appeared first on The Motley Fool Australia.

Three ASX healthcare shares that have recorded particularly strong gains are listed below. Here's why they are getting investors excited:

Advanced Health Intelligence Ltd (ASX: AHI)

The Advanced Health Intelligence share price is up 20% to 24 cents. That's despite there being no news out of the health software company. However, it is worth noting that the company's shares on the NASDAQ rocketed higher overnight. Advanced Health Intelligence recently underwent a reverse split with its US-listed shares in order to remain compliant with listing rules after trading below $1 for 33 consecutive business days.

Atomo Diagnostics Ltd (ASX: AT1)

The Atomo Diagnostics share price is up 100% to 7.1 cents. Investors have been buying this integrated rapid diagnostic test (RDT) device provider's shares this week after a major shareholder increased its holding. GZ Family Holdings has almost doubled its holding since the middle of May to approximately 79.8 million shares. This gives it a 13.98% stake in the ASX healthcare share. Last month, the company entered into an exclusive supply agreement with UK-based company Newfoundland Diagnostics for HIV rapid testing in Europe.

Lumos Diagnostics Holdings Ltd (ASX: LDX)

The Lumos Diagnostics share price is up 71% to 12.5 cents. This latest gain means this ASX healthcare share is now up approximately 1,000% over the last two trading sessions. The catalyst for this has been the granting of US FDA clearance to market its FebriDx rapid, point-of-care test in the United States. FebriDx is to be marketed for use by healthcare professionals as an aid in the diagnosis of bacterial acute respiratory infection.

The post 3 ASX healthcare shares rocketing 20% to 100% today appeared first on The Motley Fool Australia.

The S&P/ASX 200 Health Care index (ASX: XHJ) finished up 122 basis points today and has climbed over 1.6% in the past month of trade as well.

Within the basket, these three shares are standouts – but to the downside, not to the upside – after their FY22 results. Let's take a look.

Mayne Pharma Group Ltd (ASX: MYX)

Shares of Mayne Pharma finished the day more than 3% down after its FY22 earnings. Just the day prior, it had nudged past 52-week highs of 38.5 cents.

It now rests at 32 cents at the close on Friday.

In its results, the company reported a 6% gain in revenue. However, this wasn't reflected further down the income statement.

Instead, Mayne printed a net loss after tax of $263 million for the 12 months.

Investors were undoubtedly dissatisfied with the result and sold off shares en masse today, with total volume reaching almost 4.1 million shares.

Atomo Diagnostics Ltd (ASX: AT1)

Shares in Atomo also slipped further into the red today and finished 2% lower at 7.1 cents apiece.

In its report, the company printed an 83.7% year-on-year gain in revenue to $12.34 billion. However, the loss operations worsened by 5% to $5.7 million.

It also left the year with $13 million in cash and no bank debt, putting it in the position to "vigorously pursue its strategic goals in FY23".

Despite the optimism, investors weren't on board with the company today and sold down shares at a volume of more than 158% of the 4-week average.

This brings losses to 76% for the year to date for the company.

MedAdvisor Ltd (ASX: MDR)

Shares in MedAdvisor also finished the day almost 7% down at 14 cents apiece following the release of its FY22 results.

In its report, the company saw operating revenue climb by 75% year on year to $67 million, leading gross margin to climb by 17% to $35 million.

However, in tandem with the other two ASX healthcare shares mentioned above, MedAdvisor saw its loss after tax increase to $17.5 million, worse than last year's result.

Unsurprisingly, therefore, investors punished the share today and drove it back in line with its 52-week closing lows.

It seems that investors were searching for profitability within the ASX healthcare space this earnings season. Those names who failed to demonstrate it or at least a reasonable path to achieving profit are being punished.

The post 3 ASX healthcare shares punished following full-year results appeared first on The Motley Fool Australia.

The company's shares are currently swapping hands at 14.7 cents each, a loss of 18.33% on the day so far.

Let's take a look at what the diagnostic testing company reported to the market after close yesterday.

Atomo share price slips amid half-year results

Highlights of the company's half-year (H1 FY22) results include:

• Gross profit fell 30% to $1.76 million, down from $2.52 million in the previous corresponding period (PCP)
• Gross margin of 33%, down from 55% in the PCP
• Underlying earnings before interest, tax, depreciation and amortisation (EBITDA) of -$1.48 million
• Revenue up 17% on PCP (H1FY21) to $5.34 million
• Cash balance of $13.68 million at 31 December 2021

What else happened in the half?

The company said its overall gross revenue from customers grew 53% to $7 million versus the PCP. This was driven by the huge demand for COVID-19 tests. There was also growth in sales of HIV self-tests.

Atomo sold 420,000 rapid COVID tests in the first half of the 2022 financial year although the company said its January sales have outstripped total sales for the entire first half. Since then, however, market demand has fallen as "Omicron infection rates drop and free government tests impact the market".

Nonetheless, the company has more than 120 enterprise and government customers and is still seeing demand for its products.

Management commentary

In its investor presentation, Atomo said Therapeutic Goods Administration (TGA) has "significantly relaxed" conditions of supply related to home-use, self-test products in Australia.

Given greater acceptance of home testing in the community Atomo sees an opportunity to commercialise a range of rapid tests in the local market and has first mover advantage in HIV as well as established consumer product support established in country.

What's next

In the near term, Atomo sees "immediate" revenue growth potential for COVID rapid testing. In the medium term, it foresees consumers globally accepting rapid testing in the home and the increased importance of home-based healthcare solutions.

Long term, it predicts fewer regulatory barriers to home testing, particularly in the United States. It expects well-capitalised market entrants building home-delivered healthcare will emerge. And there will be more demand for convenient healthcare services.

The company said the diagnostic market has "permanently changed".

Atomo believes it can continue to meet demand for COVID tests in the Australian and New Zealand markets. HIV testing is also an opportunity and Atomo plans to target commercial agreements in the USA and China. The company also believes it has "first mover" advantage on Australia's HIV self-test market.

The company's cash balance has increased by more than $2 million since 31 December to $15.8 million at 31 January 2022.

Atomo Diagnostics share price summary

The Atomo Diagnostics share price has sunk 46% in the past year and is down 50% year to date.

For perspective, the benchmark S&P/ASX 200 Index (ASX: XJO) has returned around 5% over the past year.

Atomo has a market capitalisation of roughly $61 million based on today's share price.

The post Negative result: Atomo Diagnostics (ASX: AT1) shares plunge 18% on half-year earnings appeared first on The Motley Fool Australia.

ASX-listed companies that manufacture COVID-19 tests include Atomo Diagnostics Ltd (ASX: AT1), Lumos Diagnostics Holdings Ltd (ASX: LDX) and AnteoTech Ltd (ASX: ADO.

Atomo's share price is currently climbing 1.19% today, while Lumos is in the green 2.49 and Anteotech is jumping 6.98%.

Let's take a look at the news that could be giving these shares a bump today.

Tax deductible COVID-19 tests

COVID-19 tests for people who need them for work will be tax deductible from this year, the Financial Review reported.

Sonic Healthcare Limited (ASX: SHL) and Healius Ltd (ASX: HLS) process COVID-19 tests in Australia. Sonic has conducted millions of PCR tests, while Healius is processing 40,000 COVID-19 tests every day.

Treasurer Frydenberg will discuss the tax deduction policy in a speech to the Australian Industry Group today. In a copy of the speech, reported by the SBS, he states:

Today, I'm announcing that we will ensure that COVID-19 testing expenses are tax deductible for testing taken to attend a place of work, giving businesses and individuals more clarity and assurance.

We will also ensure that fringe benefits tax will not be incurred by employers where COVID-19 tests are provided to employees for this purpose.

The Lumos share price surged 5% last week on news the Victorian Government intends to support local manufacturing of its RAT tests.

Atomo secured up to 20 million COVID-19 rapid antigen tests for Australia and New Zealand in 2022, my Foolish colleague Aaron reported in January.

Anteotech is still awaiting Therapeutic Goods Administration (TGA) approval for use of its COVID-19 rapid antigen test in Australia.

Ellume is another Australian company working on TGA approval to sell its RATs in Australia. However, it is not listed on the ASX.

Share price recap

Some COVID-19 test shares have benefitted from the pandemic, making major gains in the past 52 weeks.

In the past year, Anteotech has rocketed 27%, while Sonic has surged 9% and Healius has gained 8%.

However, that's not true across the board. The Atomo share price has slumped 27% while the Lumos share price is down 17%.

In contrast, the S&P/ASX 200 Index (ASX: XJO) has returned more than 3.4% in the past year.

The post Why are ASX COVID test shares climbing today? appeared first on The Motley Fool Australia.

• Atomo shares accelerate on back of New Zealand approval for its antigen test
• Businesses and pharmacies allowed to supply COVID kit for sale
• Atomo has secured up to 20 million units for Australia and New Zealand

The Atomo Diagnostics Ltd (ASX: AT1) share price is racing higher during Thursday trade. This comes after the company announced it has received approval to expand its product into another key geographical market.

At the time of writing, the medical device company's shares are up 17.5% to 23.5 cents apiece. However, in early trade they were up 25% at 25 cents before partially retreating.

Atomo expands geographical presence

Investors are driving up the Atomo share price after digesting the company's latest positive news.

In a statement to the ASX, Atomo advised its COVID-19 antigen test has been approved for use in New Zealand.

The green light was given by the New Zealand Ministry of Health under the New Zealand COVID-19 public health response.

The country is currently on 'red alert' status after the Omicron variant continued to accelerate across key cities.

This follows one of the most significant turning points of New Zealand's pandemic, with the government accepting the virus. The suppression strategy is a major psychological shift from the previous pathway of aiming to achieve COVID zero.

The COVID-19 antigen test can be used by professionals such as healthcare workers and government agencies or for self-test use.

New Zealand-based businesses and pharmacies are all permitted to supply, distribute, and sell the Atomo COVID-19 antigen test.

To support demand, Atomo secured up to 20 million COVID-19 rapid antigen tests for Australia and New Zealand in 2022.

The company revealed it renegotiated its supply agreement with United States manufacturer, Access Bio, last August.

Commenting on the news driving the Atomo share price higher, managing director John Kelly said:

We are excited the Atomo antigen test has received approval for use in New Zealand and we have now commenced commercial discussions related to supply of the product to the New Zealand market.

Atomo share price summary

Over the past 12 months, the Atomo share price has moved on a rollercoaster ride to post a loss of almost 20%.

It's worth noting that despite today's strong gains, the company's shares are down by more than 21% in 2022.

Based on today's price, Atomo has a market capitalisation of roughly $100.13 million, with approximately 408.69 million shares on issue.

The post Here's why the Atomo (ASX:AT1) share price is rocketing 17% today appeared first on The Motley Fool Australia.

The stock's recent boost could be due to its involvement with COVID-19 rapid tests. Rapid tests have been the talk of the town lately as Australia faces a record wave of COVID-19 cases.

At the time of writing, the Atomo Diagnostic share price is 31.5 cents, 5% higher than its previous close.

For context, the S&P/ASX 200 Index (ASX: XJO) is up 1.3% right now.

Let's take a closer look at what might be driving the company's stock lately.

Atomo Diagnostics share price particularly festive

The Atomo Diagnostics share price has been on a roll lately. The company's shares surged 26% on Wednesday, triggering the ASX to issue a 'please explain'.

In its response, the company noted increased media attention on the topic of COVID rapid antigen tests. Indeed, rapid tests have been on many minds lately, including those of the country's decision-makers.

The same day the Atomo Diagnostics share price experienced its major leap, Prime Minister Scott Morrison announced the federal government was bringing forward a national cabinet meeting to discuss implications of the Omicron outbreak, including testing arrangements.

That meeting occurred on 30 December. It led to the introduction of new orders stating rapid antigen tests will become the go-to COVID-19 test for most Australians, with PCR tests restricted to those with symptoms and close contacts.

Additionally, Atomo Diagnostics pointed to an article published by the Sydney Morning Herald the previous day as a potential catalyst for its shares' gains.

The article discussed increasing demand from consumers and state governments for COVID-19 rapid tests.

In October, the company announced new terms to its supply agreement for COVID-19 rapid tests.

It can now purchase up to 10 million rapid tests to be used in professional settings in Australia and New Zealand and another 10 million to be sold commercially.

While the Atomo Diagnostics share price initially dived 11.7% on the new terms, the prospect of supplying more tests could be what's got the market excited about the company.

However, despite the stock's Christmas gains, the company's share price is only 1.6% higher than it was this time last year.

The post Why has the Atomo Diagnostics (ASX: AT1) share price surged 50% since Christmas? appeared first on The Motley Fool Australia.

It's been a similar story for most of the day, with the shares hitting a high of 32 cents earlier before retreating.

There has been no market-sensitive information out of the medical devices company today. However, the company has released a slew of price-sensitive information in the past few days.

Further – while not likely to have a meaningful impact on the Atomo Diagnostics share price – the company has also released its AGM address today.

Let's investigate further.

What's been happening with Atomo Diagnostics?

Atomo released its Q1 FY22 activities and earnings report on 25 October. In it, the company recognised a significant increase in revenue to $2.4 million, up 260% from the previous quarter.

Cash receipts totalled $2.2 million for the quarter, also a 206% gain from the last quarter.

Much of the growth in income stemmed from a "significant increase in Covid-19 rapid antigen test sales". The company sold more than 100,000 units compared to just 5,000 in FY21.

The company also signed an agreement with Access Bio for US$1.72 million to secure "up to 20 million Covid-19 rapid antigen tests".

The following day, Atomo released a key update regarding its HIV self-test. It said the Therapeutic Goods Administration (TGA) has "broadened the organisations to whom the HIV self-test can be applied".

This enables the company to supply its HIV self-test to any business, organisation, or institution (including a pharmacy) that has the proper training. Curiously, the varied conditions also allow the company to sell the test on pharmacy websites.

The decision also enables Atomo to advertise its HIV self-test in any form of media to be marketed in Australia.

Before these changes, Atomo said it was unable to advertise or promote its HIV self-test website or the HIV self-test product itself.

Despite these apparently positive changes, investors haven't piled into Atomo shares. Since its quarterly update on Monday night and HIV self-test announcement on Tuesday morning, the Atomo Diagnostics share price has sunk by around 13%.

News from the AGM

One other point worth mentioning is that Atomo also released the presentations from its AGM today. While not price-sensitive, investors were able to peer into the company's operations, its progress in FY21, and its future outlook.

In the report, Atomo explained it has "an opportunity to sell up to 20 million antigen tests during FY22–23".

It also sees itself capitalising on local Covid-19 opportunities, including a self-test product in this category as well.

Atomo Diagnositcs share price snapshot

It's been a difficult year to date for the Atomo Diagnostics share price, falling by 1.6%. It has also slumped by around 21% since the company listed on the ASX in April 2020.

For comparison, the S&P/ASX 200 index (ASX: XJO) has gained around 11% since the start of the year.

The post Why is the Atomo Diagnostics (ASX:AT1) share price wobbling on Thursday? appeared first on The Motley Fool Australia.

Particularly, after at-home COVID-19 antigen rapid tests, supplied by the Perth-based Australian company, received approval from the Therapeutic Goods Association (TGA) this week.  

Australians might be able to choose between one of three at-home COVID-19 rapid antigen tests from 1 November. All three are supplied by AM Diagnostics and provide results within 15 minutes.

AM Diagnostics leads Australian at-home testing

According to reporting by The Australian, the TGA's thumbs-up means Australians might soon be able to buy rapid COVID-19 tests at supermarkets, pharmacies, and other easy-to-access locations.

Two of the approved tests provide results from oral fluid, requiring a user to spit into a tube to learn their COVID-19 status. The other provides results using a nasal swab.

The tests state they are accurate 97% to 98% of the time.

Can you invest in AM Diagnostics on the ASX?

Understandably, many ASX investors are currently wondering how to get a piece of AM Diagnostics into their portfolio.

Unfortunately, there's no good news for those looking to invest in the manufacture and distributor of medical and diagnostic equipment through AM Diagnostics.  

AM Diagnostics is registered as a private company with the Australian Government. Thus, investors can't buy shares in AM Diagnostics on the ASX.

However, there are several companies that might peak the interest of would-be-AM Diagnostics investors.

Atomo Diagnostics Ltd (ASX: AT1), for instance, is the developer of the CareStart EZ COVID-19 rapid antibody test.

The company's at-home test has been authorised by the US Food and Drug Administration for emergency use.

Another ASX-listed share involved in the COVID-19 home testing market is AnteoTech Ltd (ASX: ADO).

AnteoTech has partnered with unlisted Brisbane-based company, Ellume, to provide its AnteoBind technology for Ellume's at-home COVID-19 tests.

The post Is AM Diagnostics listed on the ASX? appeared first on The Motley Fool Australia.

Four ASX shares that are falling more than most today are listed below. Here's why they are falling:

Afterpay Ltd (ASX: APT)

The Afterpay share price is down 5% to $113.49. This follows a 5% pullback in the Square share price on Wall Street overnight. Afterpay and Square have agreed to an all-script takeover deal which will see the former's shareholders receive 0.375 Square shares for each Afterpay share they own. In light of this, the value of the takeover rises and falls with the Square price.

Atomo Diagnostics Ltd (ASX: AT1)

The Atomo share price has fallen 9% to 30.5 cents. Investors have been selling the medical device company's shares following the release of an announcement this morning. According to the release, Atomo and Access Bio have restructured their commercial relationship to reflect the evolving structural changes in the COVID-19 diagnostics market.

Opthea Ltd (ASX: OPT)

The Opthea share price is down almost 5% to $1.29. This is despite the biopharmaceutical company announcing the start of enrolment for its Phase 3 pivotal clinical program of OPT-302 in Europe. This clinical program is testing OPT-302 as a treatment for wet (neovascular) age-related macular degeneration (AMD).

Sealink Travel Group Ltd (ASX: SLK)

The Sealink share price is down 5% to $7.87. This morning UBS retained its buy rating but trimmed its price target on the travel and transport company's shares to $10.20. This follows news that it failed to win the Melbourne Metro Bus Franchise contract. UBS felt that the market had been anticipating that Sealink would win this large contract. Nevertheless, UBS remains positive on the company's outlook.

The post Why Afterpay, Atomo, Opthea, & Sealink shares are falling today appeared first on The Motley Fool Australia.

At the time of writing, the medical device company's shares are down 9% to 30.5 cents.

Why is the Atomo share price sinking?

As well as being caught up in the market volatility, the Atomo share price is being sold down by investors following the release of an announcement.

According to the release, Atomo and Access Bio have restructured their commercial relationship to reflect the evolving structural changes in the COVID-19 diagnostics market.

What was the previous agreement?

In July last year, Atomo entered into an agreement with the US-based diagnostics specialist to supply its unique, integrated rapid diagnostic test (RDT) devices to Access Bio for use with its rapid test strip for detection of antibodies to COVID-19.

Under this agreement, Access Bio was obliged to sell a minimum of two million products by 30 September 2021.

The two parties then expanded the agreement a couple of months later. Under the expanded partnership, Atomo had non-exclusive rights to market and distribute Access' COVID-19 rapid antigen test in Australia, New Zealand, and India. These were to be branded as the Atomo COVID-19 Antigen Test, subject to obtaining the required regulatory approvals in each jurisdiction.

What's the latest?

Today's announcement reveals that the new agreement, which is effective immediately and expires on 31 December 2022, will see Atomo receive a one-off fee from Access Bio to replace any payments due to Atomo under the existing agreements.

However, while management considers the fee to be "material", it has not provided any colour on what that means in dollar terms. This could be weighing on the Atomo share price today.

In addition, the new agreement provides Atomo the right, but not the obligation, to purchase at a fixed price per unit up to 10 million Atomo branded COVID-19 Rapid Antigen tests between now and the end of 2022. These are for use in professional settings in Australia and New Zealand only.

This test was listed on the ARTG by the TGA in October 2020 and is currently being sold by Atomo in the Australian market in a number of channels.

What else?

Furthermore, the company has the right to purchase at a fixed price per unit up to 10 million Atomo branded COVID-19 Rapid Antigen Self-Tests. These self-tests will be able to be used in homes across Australia if approved by the TGA.

Management explained the logic behind the new agreement. It said: "The new agreement enables the parties to better align themselves to meet the opportunities resulting from changes in the diagnostic landscape in FY22."

"The termination of Atomo's OEM agreement with Access Bio will in no way affect Atomo's current HIV business where Atomo is the listed manufacturer of its own Atomo HIV Self-Test and AtomoRapid HIV professional use tests across LMIC and developed healthcare markets," it added.

The post Here's why the Atomo (ASX:AT1) share price is crashing 9% today appeared first on The Motley Fool Australia.

Atomo shares are currently in a requested trading halt, however, just prior to this announcement, were trading 1.5% higher on the day at 34 cents apiece.

Read on for more details.

Why is the Atomo Diagnostics share price halted?

Atomo advised just after lunchtime that trading of its shares is halted "pending a market update announcement (from the company) regarding its commercial arrangements with Access Bio Inc".

The trading halt will remain in effect until 6 October, unless Atomo decides to make the announcement prior to this.

Access Bio is a manufacturer of test-tube diagnostic tests, with specialties in rapid diagnostic tests for malaria and pregnancy.

Recall that Atomo had announced agreements with Access Bio last year to commercialise its rapid antigen COVID-19 tests in the Australian and North American markets.

It has since received regulatory approval in Australia and the US, using Atomo's Galileo platform to produce a test called CareStart EZ Covid-19 IgM/IgG.

In Q1 of this year, Atomo entered a partnership with Access for the company's rapid diagnostic COVID-19 tests in the North American Market, with the first product to be delivered in Q3 FY21.

So far the company has sold 1.1 million testing units to Access Bio and other partners for both the European and North American markets under this arrangement.

With the demand for rapid antibody testing for COVID-19 increasing markedly in the last few months, the company is positioned on the supply side in order to match this surge.

As it stands, more than 50 countries are using Atomo's antigen tests across a broad range of public and private sectors, according to the company.

There is yet to be any word on when Atomo will make its announcement, if or when before the 6 October.

Atomo Diagnostics share price snapshot

The Atomo Diagnostics share price has had a choppy year to date, posting a return of 11.5% since January 1.

It's rallied 58% this past month and is up a further 17% in the last week.

Despite this, Atomo shares are 9% in the red over the past 12 months, well behind the S&P/ASX 200 index (ASX: XJO)'s climb of about 25% in this time.

The post Why is the Atomo Diagnostics (ASX:AT1) share price halted? appeared first on The Motley Fool Australia.

Despite the broader selling headwinds, these 5 ASX shares (with a market capitalisation greater than $100 million) managed to top the leaderboards.

5 top performing ASX shares in September

1. Kingsgate Consolidated Limited (ASX: KCN)

The Kingsgate share price surged 103% to $1.58 last month on heavy volume after the company came forth with an encouraging update about its Thailand operations.

It is understood that the company's negotiations with the Royal Thai Government are entering their final stages.

Kingsgate is optimistic about settling a number of actionable awards including:

• The grant of all operating licences and permit applications required to re-start
  and operate the Chatree Gold Mine;
• The renewal/approval of key exploration licence applications to enable access to previously unavailable but highly prospective areas; and
• The examination by Kingsgate of options for the construction of a renewable energy plant at the Chatree Gold Mine;

2. Tuas Ltd (ASX: TUA)

Tuas was a spinoff of TPG Telecom Ltd (ASX: TPM) and its Singapore operations.

Its shares skyrocketed 70.5% to $1.45 in September following the broader strength across ASX shares in the telecommunications sector and an upbeat FY21 results announcement towards the end of the month.

3. Atomo Diagnostics Ltd (ASX: AT1)

Atomo did not announce any market-sensitive news in September but managed to take the spotlight due to its effective rapid antigen test (RAT) for COVID-19.

Its shares surged 54% in September to 35.5 cents after its management told The Australian that it can "bring in up to a million tests a week" to Australia if the demand is there.

4. Camplify Holdings Ltd (ASX: CHL)

The Camplify share price rallied strongly in September despite no market-sensitive announcements made by the company.

Shares in the caravan and campervan-sharing platform surged 65.75% to $3.

This caught the attention of the ASX, which issued a price query on 9 September. In response to its surging share price and volumes, the company pointed to its recent preliminary final report on 23 August as well as recent information by state and federal governments regarding the easing of COVID-19 related restrictions that may have impacted its trading performance.

5. Arafura Resources Limited (ASX: ARU)

The Arafura share price skyrocketed 50% in September following reports from Bloomberg and the Australian Financial Review that the company was in discussions with European manufacturers for offtake agreements for the supply of rare earths.

Interestingly, the news was speculative in nature, as Arafura would later clarify with the ASX that these discussions were not "formal or binding agreements … and negotiations are incomplete".

The post These were the 5 top performing ASX shares in September appeared first on The Motley Fool Australia.

Atomo shares are now changing hands at 33 cents apiece, a 15.79% jump from the open. This comes despite no market-sensitive news today.

Let's dive in to see what's fuelling the Atomo Diagnostics share price.

A quick refresher on Atomo Diagnostics' position

Atomo is a medical devices company that supplies rapid antigen tests (RATs) to the clinical diagnostics market.

Atomo has been supplying its own RAT for COVID-19 to Australian businesses in order to gain traction. However, it has received little support from the Australian government, which prefers the PCR pathology test.

Just a side note – Atomo's RAT isn't trying to replace laboratory tests, like the PCR version. But experts say RATs lend a better speed and rate of testing the masses than the current state-backed testing regime.

This is especially true as the Delta outbreak has quashed Australia's dreams of reaching a zero-COVID utopia. Instead, the complexity of lockdowns, lengthy pathology test result times, and vaccine rollouts have plugged the speed of Australia's COVID-19 recovery.

In comes the demand for rapid antigen testing

Various sources have voiced their concern about the turnaround times of pathology testing for COVID-19.

However, the federal government is concerned about the accuracy of RATs, versus the conventional PCR test regime that can take several days to turn around results. For comparison, Atomo's RATs can deliver results in 10 minutes.

Considering where Australia now stands with its "road to recovery" plan from COVID-19, it starts to make sense why Atomo's rapid testing protocol is an attractive proposition for businesses.

And given it is one of the only ASX-listed companies with a track record of producing rapid antigen testing for COVID-19, it starts to make sense why the Atomo Diagnostics share price could benefit from a surge in testing demand.

One roadblock to the full adoption of rapid testing is that the government fully subsidises PCR testing, but not rapid testing. Some say this creates a cost issue.

Although, Atomo has already supplied its CareStart EZ COVID-19 test to a number of agencies, such as the Olympic team and aged care facilities, and even for free in some instances.

What next for Atomo Diagnostics?

Currently, the company is manufacturing inventory in the US, after its COVID-19 rapid tests received regulatory approval there.

In fact, Atomo can "bring in up to a million tests a week" to Australia if the demand is there, the company's CEO John Kelly told The Australian yesterday.

"It depends on how extensive the rollout is and what government policies now start to appear on deployments outside corporates," Kelly said.

"We are about to roll out a program to offer testing to smaller businesses that want to reopen…They can register and get trained onsite and then set up their own staff testing protocols under telehealth supervision."

The Atomo Diagnostics share price has climbed 47% over the last week. This coincides with the NSW Government's pandemic rollback and "freedoms" announcements.

Logically, demand for COVID-19 tests will no doubt be high over the entire "reopening" as risk mitigation.

Atomo Diagnostics share price snapshot

The Atomo Diagnostics share price has posted a return of around 6% since January 1. Aside from this, Atomo Diagnostics' shares are down 11% over the past 12 months.

Both of these results have lagged the S&P/ASX 200 index (ASX: XJO)'s gain of around 25% over the past year.

The post Why the Atomo Diagnostics (ASX:AT1) share price has rallied 15% today appeared first on The Motley Fool Australia.

In the last 7 days, shares in the medical device company have soared more than 30%.

Let's take a look at why the Atomo share price is flying.

Demand for rapid testing fuelling Atomo share price

In the past week, Atomo has not released any price-sensitive news that could explain the bullish price action.

As a result, various other catalysts could be fuelling investor demand for the company's shares.

With the Delta outbreak threatening to get out of hand in Australia, there has been increasing demand for rapid testing solutions.

Australia has largely relied on pathology testing in fighting the COVID-19 pandemic.

However, various sources have reflected concern on their turnaround time for results.

Pathology testing can take up to three days to deliver a result, by comparison, rapid antigen tests can detect COVID-19 in as little as 10 minutes.

Atomo is one of the few listed companies in Australia that has produced rapid COVID-19 testing.

Of particular interest is the company's rapid antibody test CareStart EZ COVID-19, which was developed in conjunction with its partner Access Bio.

Earlier this year, Access Bio received Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA) for point-of-care use of its CareStart EZ COVID-19 test.

The biotech has supplied its CareStart EZ COVID-19 test to various Olympic and sporting teams, whilst also supplying aged care providers.

More on Atomo

Atomo is a medical device company that supplies rapid diagnostic test devices to the global diagnostic market. The company's patented devices simplify testing procedures and enhance useability for professional users.

The biotech recently published its full-year results for FY21, which was highlighted by a 25.1% increase in revenue to $6.72 million.

Other highlights from Atomo's report included;

• Cost of sales up 52% to $3.3 million
• Gross profit up 7% to $3.42 million
• Underlying operating loss widened 101% to $4.79 million
• Cash balance of ~$18 million

According to Atomo, revenue was largely driven by consumer demand in Europe and North America for its COVID-19 antibody tests.

At the time of writing, shares in Atomo are trading slightly lower for the day at 28 cents.

The post Why the Atomo Diagnostics (ASX:AT1) share price has soared 30% in a week appeared first on The Motley Fool Australia.

Earlier today, the medical device company's shares fell as much as 8% to 22.5 cents. This was in response to the release of its full year results.

Atomo Diagnostics share price falls after losses double in FY 2021

• Revenue increased 25% to $6.72 million
• Cost of sales up 52% to $3.3 million
• Gross profit up 7% to $3.42 million
• Underlying operating loss widened 101% to $4.79 million
• Cash balance of ~$18 million

What happened for Atomo in FY 2021?

For the 12 months ended 30 June, Atomo reported a 25.1% increase in revenue to $6.72 million.

This was driven largely by demand for devices from customers in Europe and North America for the production of COVID-19 antibody tests.

Also supporting its sales growth was demand in Australia for Atomo branded COVID-19 rapid antibody and antigen tests and its HIV products in Australia and internationally.

What did management say?

Management was pleased with the company's performance during a year filled with both headwinds and tailwinds.

It commented: "Atomo's activities continued throughout FY21 nothwithstanding the COVID-19 pandemic. There were some delays in activity caused by the pandemic, for example, the global tender for HIV Self Tests run by Unitaid was substantially delayed, the consequence of which was that Atomo's revenue from that tender was modest and primarily occured at the very end of the financial year."

"That said, a significant portion of additional revenue was driven by demand for Atomo's COVID-19 products in Australia and for its platforms for use by OEM customers in their own COVID-19 rapid tests internationally," it added.

What's next?

No guidance was given for the year ahead, which could be weighing on the Atomo share price a touch today.

However, management has stated that it is prioritising the continued expansion of strategic commercialisation partnerships across key global markets. This includes seeking a US market entry partnership.

In addition, it is aiming to expand its COVID-19 revenues with a core focus on the Australian market. It will also target HIV sales growth in existing territories and look to secure commercial agreements in new territories.

The post Atomo Diagnostics (ASX:AT1) share price sinks 8% on FY21 results appeared first on The Motley Fool Australia.

The medical device company finished the day up 4.55% at 23 cents.

Atomo shares have seen greater interest as Australia battles to control a new wave of COVID-19 infections.

Here's why the Atomo share price is getting extra attention today.

Atomo share price up on COVID-19 rapid testing

The Atomo share price has come under the spotlight as the COVID-19 pandemic threatens to get out of hand in Australia.

Although Atomo has not released any price-sensitive news today, an article in The Australian could explain why shares in the biotech are racing higher.

The article highlighted the benefit of rapid antigen testing for COVID-19, as the outbreak in Australia worsens.

Australia has largely relied on pathology testing to detect positive cases and assist contact tracers.

However, given the rapid spread of the recent COVID-19 outbreaks, the need for rapid antigen testing has grown.

According to the article, rapid antigen tests can detect COVID-19 in as little as 10 minutes. By comparison, pathology testing can take up to three days to deliver a result.

In particular, the article highlighted the rapid COVID-19 test produced by Atomo.

The article noted that Atomo's rapid tests have been supplied to various Olympic and sporting teams.

The tests have also been supplied to aged care providers.

The article also highlighted that Atomo has been supplying tests to the Australian Defence Force and mining and oil companies.

In the article, Atomo's Chief Executive John Kelly said:

"And the problem is exacerbated by the fact that to get a product accepted in the state healthcare systems it really needs to be reimbursed. It's been extremely difficult, nigh impossible, for point-of-care diagnostics to get reimbursement in Australia."

More on the Atomo share price

Atomo is a medical device company that supplies rapid diagnostic test devices to the global diagnostic market. The company's patented devices simplify testing procedures and enhance useability for professional users.

Of particular interest is Atomo's CareStart EZ COVID-19 test.

CareStart EZ COVID-19 is a rapid antibody test, developed by Atomo in conjunction with its partner Access Bio.

Most recently, the Atomo share price received a boost after announcing that Access Bio received Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA) for point-of-care use of its CareStart EZ COVID-19 test.

Shares in the medical device company hit an intraday high of 24 cents today.

The post Here's why the Atomo (ASX: AT1) share price flew 4% higher today appeared first on The Motley Fool Australia.

At the time of writing, the Atomo share price is trading 9.30% higher at 23.5 cents apiece.

How did Atomo perform for the quarter?

The Atomo share price is soaring after the company reported a robust performance during the fourth quarter.

For the period ending 30 June, Atomo recorded cash receipts from customers of $717,000, bringing the full-year to $8.01 million. It's worth noting that shortly after the close of Q4 FY21, a further $750,000 was received.

Sales represented a total of $6.7 million for the 2021 financial year, up by 25% when compared to FY20 ($5.4 million).

Atomo ended the quarter with a cash balance of $17.95 million.

Pleasingly, the company is expecting sales to expand rapidly in FY22, with key multi-year agreements secured with Viatris and Unitaid. HIV self-testing kits – designed and manufactured by Atomo – will be sent to 135 low and middle-income countries.

During late in the fourth quarter, the company received an initial order of 250,000 units under the Unitaid purchasing program. These products have since been shipped and delivered, with the majority of the order to be fulfilled in Q1 FY22.

To support the large order and potential future orders, Atomo has expanded operations at its South African facility. This includes additional assembly and packaging lines, as well as hiring and training further staff.

Across in the United States market, Atomo revealed that discussions with Access Bio were ongoing in relation to delivering its COVID-19 antibody test kits. Previously, Access Bio ordered 260,000 devices from Atomo, in part of the take-or-pay commitment of 2 million units by 30 September.

In Australia, interest has soared regarding Atomo's COVID-19 rapid tests. The company has engaged with the Australian Aged Care market to develop its first aged care COVID-19 rapid antigen screening program.

Atomo share price summary

Despite the positive turn of events, Atomo shares have gradually trekked lower in the past 12 months, posting a 44% loss. In 2021 alone, the company's share price is down around 30%.

Atomo has a market capitalisation of roughly $87.8 million, with more than 408 million shares on its registry.

The post The Atomo (ASX:AT1) share price has shot up 9%. Here's why appeared first on The Motley Fool Australia.

While it would be the dream of many investors to see Ellume debut on the ASX, we have these shares to keep an eye on until then.

Quick refresher on Ellume

Ellume is a Brisbane-based developer of digitally enabled diagnostic products. Nowadays, however, it's most well known for its at-home rapid COVID-19 tests.

Ellume's rapid COVID-19 test was the first to receive emergency approval from the United States Food and Drug Administration (FDA).

As The Motley Fool has previously reported, the test developed by Ellume costs around US$30 and takes around 20 minutes to show a result.

It has a 94% success rate when detecting COVID-19. It also has a 96% success rate in detecting the virus is not present.

Why Ellume is boosting ASX shares

Right now, reports are swirling that both state and federal governments are facing pressure to approve the use of at-home COVID-19 tests like Ellume's.

However, as we reported here, there's a lot of pushback from government and experts.

But not all hope is lost. News of the unlisted company tends to boost a number of ASX listed shares.

AnteoTech Ltd (ASX: ADO)

Potentially the closest share to Ellume on the ASX is AnteoTech. Right now, shares in AnteoTech are trading for 8.89% more than their previous close. The AnteoTech share price is 25 cents.

One of AnteoTech's major customers is Ellume. Ellume uses AnteoTech's AnteoBind technology in their rapid COVID-19 tests.

AnteoTech generally moves when we hear about Ellume.

Atomo Diagnostics Ltd (ASX: AT1)

Another share that's been boosted by today's news is Atomo Diagnostics.

Atomo also creates at-home COVID-19 rapid tests. The company partners with Access Bio to bring its integrated device together with Access Bio's rapid COVID-19 antibody test strips. The resulting at-home rapid test is named CareStart COVID-19 IgM/IgG.

The CareStart COVID-19 lgM/lgG received FDA emergency use approval last month.

The Atomo share price is currently 10% higher, with shares in the company trading for 22 cents apiece.

Memphasys Ltd (ASX: MEM)

Memphasys is another biotech share that the market tends to get excited about when word of Ellume hits the streets. The Memphasys share price is 4.62% higher today, trading at 6.8 cents.

The post Ellume is making news and these ASX shares are surging, again appeared first on The Motley Fool Australia.