Lumos has today announced a pivotal commercial development for its breakthrough diagnostic product, FebriDx®.
Lumos Diagnostics has signed a six-year exclusive U.S. distribution agreement with PHASE Scientific - a fast-growing biotech company focusing on innovative diagnostics and healthcare solutions that is headquartered in Hong Kong with offices in Southern California and in the Greater Bay Area.
PHASE Scientific has agreed to pay $US2.0 million upfront, comprising US$1.0 million exclusivity fee and US$1.0 million pre-paid purchase order. A further US$1.5 million pre-paid purchase order will become payable on FebriDx CLIA waiver application to the U.S. Food and Drug Administration (FDA) - expected within the next three months.
An additional non-refundable, prepaid purchase commitment of US$5 million will be triggered on granting of the U.S. FDA CLIA Waiver.
Lumos is currently conducting a CLIA waiver study designed to enable FebriDx to be used in a broader range of healthcare settings, including U.S. physician offices, urgent care clinics, or other outpatient clinics that do not operate under moderate-complexity laboratory certification. The study is expected to be completed in August.
Lumos expects to generate total contract value of up to US$317 million over the six-year term.
Lumos Diagnostics CEO and MD, Doug Ward, said:
“This distribution agreement reflects a pivotal moment in Lumos’ evolution. We look forward to working with the PHASE Scientific team to ensure that FebriDx® secures adoption in the U.S. market, delivering tangible clinical and financial value to the broader healthcare system.”
“This agreement validates the value of the FebriDx® technology and provides a clear pathway to the U.S. market, which we expect will accelerate rapidly, should we secure the CLIA waiver classification from the FDA.”
Click here to read the ASX release.