Lumos Diagnostics (ASX:LDX) has signed an exclusive US distribution and supply agreement for FebriDx, valued at up to US$317 million (approximately AUD$487 million), with PHASE Scientific International.
FebriDx is a rapid point-of-care test that helps clinicians differentiate between bacterial and nonbacterial acute respiratory infections through a simple fingerstick blood sample in around ten minutes.
PHASE Scientific is headquartered in Hong Kong with offices in Southern California and the Greater Bay Area.
Lumos CEO 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 US 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 [Clinical Laboratory Improvement Amendments] waiver classification from the FDA.”
The agreement includes a US$1 million non-refundable exclusivity payment on signing, and an additional US$7.5 million in non-refundable prepaid purchase orders, payable in three tranches.
Assuming PHASE Scientific meets all the payment milestones above and the minimum order quantities specified in the agreement, Lumos expects the total value of the agreement to reach up to US$317 million over its lifetime.
PHASE Scientific founder and CEO, Dr Ricky Chiu, said, “PHASE Scientific is proud to partner with Lumos as their exclusive US distributor for FebriDx, and to welcome it into our INDICAID family — our trusted rapid diagnostics brand known for accessibility and quality. With strong product differentiation and a CLIA waiver on the horizon, FebriDx is poised to transform the landscape of rapid respiratory diagnostics and clinical decision-making. Backed by PHASE’s record of having sold over 100 million INDICAID tests and a nationwide network of urgent care centres and clinics, we’re uniquely positioned to bring this innovation to the frontlines of care, where speed, accuracy, and reliability matter most.”
Lumos is currently conducting a CLIA waiver study designed to enable FebriDx to be used in a broader range of healthcare settings, including US physician offices, urgent care clinics, or other outpatient clinics that do not operate under moderate-complexity laboratory certification.
As of July 9, the study has enrolled 105 bacterial-positive patients, of the targeted 120 required for the study.
Lumos’ non-executive chairman, Sam Lanyon, added, “I want to congratulate our CEO, Doug Ward and the team on today’s pivotal milestone, and to welcome PHASE Scientific as our exclusive US FebriDx distributor. We believe FebriDx is a product that can have a very significant, positive impact on patients’ healthcare outcomes, and are delighted to see the US commercialisation and distribution of FebriDx in the hands of a highly supportive and motivated partner.”