The waiver opens the door to more than 300,000 point-of-care settings across the US, reaching an estimated 80 million patients annually.
A rapid point-of-care test designed to help clinicians distinguish bacterial from non-bacterial respiratory infections has received a Clinical Laboratory Improvement Amendments (CLIA) waiver from the Food and Drug Administration (FDA), significantly expanding the settings in which it can be deployed.
FebriDx, which previously received 510(k) clearance, can now be used across any facility operating under a Certificate of Waiver, including physician office laboratories, urgent care clinics, retail health and pharmacy clinics, and long-term care facilities. The test delivers results in approximately 10 minutes from a fingerstick blood sample, offering frontline clinicians rapid, actionable decision support without the need for a traditional laboratory setting.
PHASE Scientific, the exclusive US distributor of FebriDx under a previously announced distribution agreement with Lumos Diagnostics, made the announcement on March 27.
What the Waiver Means for Point-of-Care Access
The CLIA waiver materially broadens the test’s addressable market. According to a release from PHASE Scientific, the waiver expands potential access to over 300,000 US locations, reaching an estimated 80 million patients annually who present with acute respiratory infectionsy.
Prior to the waiver, FebriDx use was restricted to higher-complexity laboratory settings. With CLIA-waived status, the test can now operate at the point of care in the outpatient and community health settings where the majority of acute respiratory illness is evaluated and managed.
FebriDx is already in use at Wellstreet Urgent Care and is expected to expand across Wellstreet’s 140-plus CLIA-waived locations following the waiver, according to a release from PHASE Scientific.
Commercial Infrastructure Already in Place
PHASE Scientific says it entered Q2 2026 with its commercial infrastructure largely built out in anticipation of the waiver. The company has onboarded FebriDx with major US medical-surgical distributors and has trained hundreds of distributor sales representatives. It has also engaged a contract sales organization of more than 100 representatives with experience in the point-of-care diagnostics space.
“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,” says Ricky Chiu, founder and CEO of PHASE Scientific, in a release. “With CLIA waiver now granted, we are positioned—through our exclusive US 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 US.”
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