FDA upholds rejection of Lumos Diagnostics’ (ASX:LDX) FebriDx

• The FDA upholds its decision to reject Lumos Diagnostics’ (LDX) application to market its FebriDX product in the US
• While Lumos appealed the original rejection, the company says the FDA was unable to consider any new information under this appeal and, as such, upheld its original call
• The company will now shift its focus to commercialising the product in markets where it already has clearance, which includes the UK, Canada and Australia
• Meanwhile, Lumos has completed the closure of its Sarasota facility and relocated its manufacturing capability to its Carlsbad site in California
• Shares in Lumos closed 13.33 per cent lower at 5.2 cents per share

The FDA has upheld its decision to reject Lumos Diagnostics’ (LDX) application to market its FebriDX product in the US.

The company appealed the FDA’s rejection back in July and requested a supervisory review. The regulator had flagged concerns that the product, which is designed to tell the difference between bacterial acute respiratory infections (ARIs) and viral ARIs, could result in a further spread of COVID-19 due to potential false negatives.

Lumps said under the review process, however, the FDA was unable to consider any new information and, as such, upheld its original call.

CEO Doug Ward said this was “disappointing”, as the company believed there was a significant need and opportunity for FebriDx in the US.

“We are committed to ensuring that investment and expenditure are closely aligned to achieving commercial outcomes for Lumos,” Mr Ward said.

“At this time, this means focusing our efforts on building our services and manufacturing businesses and selling our own POC diagnostic products in markets where they are cleared.”

Lumos said it had the option to file a new application to the FDA for FebriDx, but this would require further investment and time to generate the data necessary to potentially get the device across the line.

As such, the company has instead shifted its focus to commercialising the product in markets where it already has clearance, and it does not intend to further invest in activities directed towards securing US clearance for FebriDx for now.

Meanwhile, Lumos has completed the closure of its Sarasota facility and relocated its manufacturing capability to its Carlsbad site in California.

The company closed the facility as part of an ongoing program to reduce its cash burn and future investment commitments.

Lumos was able to successfully negotiate a termination of the lease for the site with a final payment of US$300,000 (A$465,000). The move has relieved the company of more than US$3.1 million in future lease payment obligations and additional facility running costs.

“Despite its complexity, this has ended up being a remarkably seamless transition that has not resulted in any disruption to our operations, which is critical as we continue to build our pipeline of commercial projects,” Mr Ward said.

Shares in Lumos closed 13.33 per cent lower at 5.2 cents per share.