Key points
- The Lumos Diagnostics share price is rising today
- COVID-19 rapid antigen tests are in focus this week
- The company's CoviDX RAT test is waiting on TGA approval
The Lumos Diagnostics Holdings Ltd (ASX: LDX) share price is rising today as COVID-19 rapid antigen tests (RATS) hit the headlines.
At the time of writing, the company's share price is trading hands at 1.01, up 1.5%.
Let's take a look at what might be impacting the company's share price.
Awaiting TGA approval
The Lumos Diagnostics share price has been skyrocketing in recent weeks as demand for COVID-19 RAT tests increases globally.
Since Christmas Eve, the company's shares have gained 44%, rising from 70 cents to the current share price. Lumos Diagnostics achieved record revenue of $22.7 million in the 2021 financial year, up 188% from FY2020.
The company is one of a few in Australia — including Brisbane-based AnteoTech (ASX: ADO) — waiting on TGA approval for its diagnostic test despite lodging the application in September, ABC News reported.
Executive chairman Sam Lanyon told the publication.
We're working with the TGA on adding some additional clinical data to the application".
The company currently has manufacturing facilities for its rapid antigen tests in Florida and California in the United States, but not Australia.
In an investor presentation provided to the market in August, the company said it is hoping to launch its CoviDx rapid COVID-19 antigen test solution in the US, Canada and Australia in FY22 pending regulatory approvals.
This CoviDX RAT can return a result within 15 minutes of a viral swab.
The company approached Federal and State governments about local manufacture of the tests from mid-2020, but got nowhere with these discussions due to the preference for PCR tests, the ABC reported. Mr Laynson said:
For that reason, we set up our manufacturing capability out of Florida and California, which is there today, providing our range of tests into the US, European and Canadian markets at this point in time.
Lumos also has another flagship product, FebriDX, which can tell the difference between bacterial and viral infections. This product was launched in more than 100 pharmacies in the UK this week. FebriDX is also approved in Europe, Canada and Australia.
Share price snapshot
The Lumos Diagnostics share price has shed 19% in the past 52 weeks but is up 29% in the past month.
For comparison, the S&P/ASX 200 Index (ASX: XJO) has returned nearly 11% to investors in the past year.
The company commands a market capitalisation of roughly $152 million based on the current share price.
