PHASE Scientific and Lumos Diagnostics Partner on Rapid POC Test for Bacterial Respiratory Infection

A critical gap exists in the diagnosis of respiratory infections, which are often difficult to distinguish quickly and accurately as either bacterial or non-bacterial in origin. This challenge has led to widespread overuse of antibiotics, a key contributor to antimicrobial resistance (AMR), which is a growing threat to public health and a driver of unnecessary healthcare costs. Clinicians are often forced to make treatment decisions without rapid diagnostic support, particularly in urgent and emergency care settings. The lack of point-of-care solutions that can differentiate infection types contributes to inefficient triage, delays in care, and inappropriate prescribing. Now, a rapid point-of-care test that distinguishes between bacterial and non-bacterial respiratory infections can improve antimicrobial stewardship and clinical decision-making across the U.S.

PHASE Scientific (Hong Kong, China) has entered into an exclusive U.S. distribution agreement with Lumos Diagnostics (Carlsbad, CA, USA) for FebriDx, a first-in-class rapid test that aids in the diagnosis of bacterial acute respiratory infection and differentiation from non-bacterial etiology in approximately 10 minutes using a single drop of blood. FebriDx from Lumos Diagnostics will become part of PHASE Scientific’s INDICAID portfolio, which is known for its high-quality, accessible rapid diagnostics. The test uses a unique combination of C-reactive protein (CRP) and Myxovirus resistance protein A (MxA) biomarkers to aid diagnosis. Its lateral flow format requires only a fingerstick blood sample and is designed to deliver results in about 10 minutes. FebriDx was validated in a pivotal clinical study, which showed that integrating the test into care can reduce unnecessary antibiotic use, improve patient outcomes, and lower healthcare costs. It enables faster, more informed treatment decisions in urgent and outpatient care settings.

A CLIA waiver study is currently progressing, with completion and application submission expected within the next three months. The product has received FDA 510(k) clearance, and the pending CLIA waiver application will broaden access to outpatient settings. FebriDx supports antimicrobial stewardship by helping clinicians reduce inappropriate prescribing and streamline clinical workflows. The solution is expected to expand significantly in the U.S. market, supported by PHASE Scientific’s proven commercial distribution network, which has delivered over 100 million diagnostic tests. The test targets a market opportunity of approximately USD 1.5 billion. Future efforts include expanding FebriDx’s accessibility through regulatory approval and further strengthening its integration into routine point-of-care diagnostics.

"We are thrilled to partner with Lumos, a company that shares our commitment to shaping the future of healthcare through innovation and collaboration, and support them with our scalable go-to-market strength in North America," said Dr. Ricky Chiu, Founder and CEO of PHASE Scientific. "A powerful complement to our INDICAID respiratory portfolio, FebriDx is a first-in-class diagnostic that perfectly aligns with our mission to bring fast, actionable diagnostics to the frontlines of care. We are confident this will unlock synergistic opportunities, further advancing our impact on antimicrobial stewardship and clinical decision-making across the U.S. As we continue to expand the INDICAID brand, we remain dedicated to strengthening our leadership in point-of-care solutions, empowering clinicians, and improving access to high-quality healthcare."

"This distribution agreement reflects a pivotal moment in Lumos' evolution,” said Doug Ward, CEO of Lumos Diagnostics. “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 also 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 receive a grant for CLIA waiver from the FDA.”

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