- Shares in Lumos Diagnostics (LDX) slump after the FDA deprioritised an application to have the company’s CoviDx tech approved for emergency use authorisation (EUA)
- The meditech company says the FDA has paused its review of the EUA
- CEO Rob Sambursky says the company is disappointed with the decision from the US drug regulator
- Lumos’ CoviDx rapid antigen test product is designed to detect COVID-19, including variants first discovered in the UK, South Africa and Denmark
- Shares in Lumos Diagnostics are down 9.68 per cent and trading at 98 cents at 3:33 pm AEST
Shares in Lumos Diagnostics (LDX) have slumped today after the US Food and Drug Administration (FDA) deprioritised an application to have the company’s CoviDx tech approved for emergency use authorisation (EUA).
The meditech company told investors this morning the FDA had deprioritised Lumos’ request for EUA for its COVID-19 test kit and has paused its review of the EUA for the time being.
Lumos President and CEO Rob Sambursky said the company was disappointed with the decision from the US drug regulator.
“We believe CoviDx has an important role in the rapid identification of patients potentially infected with COVID-19, and Lumos will continue to work with the FDA to secure regulatory clearance for CoviDx,” Mr Sambursky said.
Lumos’ CoviDx test kit already has CE Mark approval in Europe and is undergoing regulatory review in other markets, according to the company.
Meanwhile, the company said it was busy developing its ViraDx point of care test, which was designed to test for COVID-19 and the common flu simultaneously.
Lumos’ CoviDx rapid antigen test product is designed to detect various variants of COVID-19, including those first discovered in the UK, South Africa and Denmark.
According to Lumos, the test kit can detect COVID-19 in just 15 minutes through conventional nose or throat swabs. The speed at which the virus can be detected means patients can be tested and re-tested frequently to determine when they were most contagious.
Lumos said the CoviDx test could optimise patient isolation decisions.
However, in the product description for the CoviDx test kit on Lumos website, the company makes no mention of the Delta variant of the virus, which first originated in India.
The Delta variant accounts for the majority of new infections in the US. While Lumos has not specified what role this played in the FDA’s decision, the possible lack of Delta-variant detection from CoviDx may have played a role in the EUA delay.
Shares in Lumos Diagnostics were down 9.68 per cent and trading at 98 cents at 3:33 pm AEST. The company has a $151 million market cap