PHASE Scientific Announces U.S. FDA CLIA Waiver for FebriDx®

March 27 2026, Hong Kong SAR, China and Garden Grove, California, U.S. – PHASE Scientific, the exclusive U.S. distributor of FebriDx® under its previously announced distribution agreement with Lumos Diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for FebriDx®, following the test’s 510(k) clearance (K260787).
 

The CLIA waiver materially expands the settings in which FebriDx can be used, enabling broad adoption across CLIA-waived point-of-care (POC) environments and significantly increasing the reachable customer base. FebriDx is a rapid POC test that helps clinicians differentiate between bacterial and non-bacterial respiratory infections in approximately 10 minutes using a fingerstick blood sample.
 

Expanding access across point-of-care healthcare settings

With CLIA-waived status, FebriDx can be used across a wide range of settings operating under a Certificate of Waiver, including physician office laboratories, urgent care clinics, retail health and pharmacy clinics and long-term care facilities. The waiver expands potential access to over 300,000 U.S. locations, reaching an estimated 80 million patients annually who present with acute respiratory infections, and represents a US$1.0+ billion market opportunity.
 

PHASE Scientific prepared to launch at scale through established distribution

PHASE Scientific enters this expanded market with a launch plan supported by an established commercial footprint and contracted channel partners. The company has onboarded FebriDx with the major US medical-surgical distributors and has spent Q1 preparing for CLIA waiver commercialization.
 

PHASE Scientific has trained hundreds of distributor sales representatives in preparation for launch and has engaged a contract sales organization comprising of 100+ contract sales representatives with expertise in the point-of-care diagnostics space.
 

FebriDx is currently used in Wellstreet Urgent Care and is expected to expand across Wellstreet’s 140+ CLIA-waived locations following the waiver—reflecting demand for rapid, actionable decision support in frontline outpatient care.
 

“FebriDx is a powerful complement to our INDICAID® respiratory portfolio and aligns with our mission to bring fast, actionable diagnostics to the frontlines of care,” said Dr. Ricky Chiu, Founder and CEO of PHASE Scientific. “With CLIA waiver now granted, we are positioned—through our exclusive U.S. distributorship, national distributor relationships, and scaled field readiness—to support broad point-of-care adoption across the outpatient settings where respiratory infections are most commonly evaluated. We believe this expansion can meaningfully advance antimicrobial stewardship and improve clinical decision-making across the U.S.”

For more information about FebriDx, click HERE.