US FDA rejects Lumos Diagnostics (ASX:LDX) FebriDx application

• Lumos Diagnostics (LDX) receives a significant blow to future commercial plans after the US FDA rejects the company’s application to market its FebriDx product in the USA
• FebriDx is designed to tell the difference between bacterial acute respiratory infections (ARIs) and Viral ARIs — reducing the overprescription of antibiotics
• The FDA rejected the 510(k) application over concerns the product could produce false negatives, leading to “missed opportunities to treat patients” and potentially to further spread of COVID-19
• The company says receiving approval was a “key component” of its future commercial plans, and it will now appeal the FDA’s decision or potentially submit a new application
• LDX shares dropped 65.5 per cent to trade at 5.7 cents at 1:53 pm AEST

Lumos Diagnostics (LDX) has received a significant blow to its future commercial plans after the US Food and Drug Administration (FDA) knocked back its application to market the Lumos FebriDx product in the States.

The FDA rejected the 510(k) application for FebriDx over concerns of a risk of potential false negatives that could result in the further spread of SARS-CoV-2, the virus that causes COVID-19.

The FebriDx product is designed to tell the difference between bacterial acute respiratory infections (ARIs) and viral ARIs. This is important because a bacterial infection can be treated with antibiotics, while a viral infection cannot.

Lumos said before the COVID pandemic hit, the FebriDx test had previously met the criteria necessary to successfully receive FDA approval, in accordance with the company’s pre-submission.

However, with the US’ high COVID case numbers and deaths, the FDA was concerned that false viral negatives from the test “could lead to missed opportunities to treat patients or contribute to the further spread of SARS-CoV-2 infections.”

Lumos is now looking at other options to receive regulatory clearance by the FDA for FebriDx, including an appeal, which would return a decision within 90 days, or potentially a new 510(k) submission.

The company said senior management would now conduct a “deep dive into relevant correspondence between Lumos and the FDA” to find “the most comprehensive and appropriate evidence to address the FDA’s feedback” when making the appeal.

“Clearly this was not the outcome that the company was seeking, and this decision from the FDA is a significant disappointment for Lumos,” Lumos CEO Doug Ward said.

“The US launch of FebriDx was a key component of Lumos’ future commercial plans. I will be actively working with our regulatory team and advisors to review this feedback and to develop a revised commercial plan for Lumos to incorporate this unexpected development.”

Lumos has previously received regulatory registrations for the use of FebriDx in the UK, Europe, Canada, UAE, Brazil and Australia.

LDX shares fell 65.5 per cent to trade at 5.7 cents at 1:53 pm AEST.