Introduction of FebriDx will enhance PHASE Scientific’s INDICAID portfolio and strengthen its leadership in point-of-care respiratory diagnostics.
PHASE Scientific, a fast-growing biotech company known for its science-driven innovation and commitment to improving healthcare outcomes, announced that it has entered into an exclusive U.S. distribution agreement with Lumos Diagnostics for FebriDx, a rapid point-of-care (POC) 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.
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With strong product differentiation, FDA 510(k) clearance, and an anticipated CLIA waiver application within the next three months, FebriDx is poised to transform how clinicians diagnose and manage respiratory infection.
FebriDx will become part of PHASE Scientific’s INDICAID portfolio – a trusted brand for high-quality, accessible rapid diagnostics. The partnership marks a significant milestone in PHASE’s commercial expansion in the United States, building upon a nationwide network of urgent care centers, clinics, and healthcare providers and a proven track record of distributing over 100 million INDICAID® tests.
“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.”
Doug Ward, CEO of Lumos Diagnostics, commented, “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 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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Transforming Respiratory Infection Diagnosis
FebriDx fills this diagnostic gap with a rapid, point-of-care test that uses a unique combination of C-reactive protein (CRP) and Myxovirus resistance protein A (MxA) biomarkers to aid in the diagnosis of bacterial from non-bacterial respiratory infections after 10 minutes. Its lateral flow format requires only a fingerstick blood sample and has been validated in a pivotal clinical study and demonstrated good diagnostic performance that can, in turn, improve diagnostic confidence and antibiotic stewardship decisions.
By enabling faster, more informed treatment decisions, FebriDx supports more targeted care in busy patient settings – currently including urgent and emergency care. A CLIA waiver study is progressing well, with anticipated study completion and application submission expected within the next three months. This would expand access to FebriDx across a broader range of outpatient environments, representing a market opportunity of approximately US$1.5 billion.
Driving Antimicrobial Stewardship
FebriDx plays a critical role in aiding in addressing the global threat of antimicrobial resistance (AMR), which continues to strain public health systems and drive avoidable costs. By providing rapid, actionable results at the point of care, FebriDx helps reduce unnecessary antibiotic prescribing – a key contributor to AMR – and improves clinical workflows by supporting more accurate triage and treatment.
Clinical studies have demonstrated that integrating FebriDx can lead to reduced antibiotic use, lower healthcare costs, and better patient outcomes. Its unique ability to guide appropriate prescribing makes it a valuable tool in everyday patient care.
Strengthening U.S. Market Presence
This agreement represents a major step in PHASE Scientific’s strategy to reinforce its dual strengths in R&D innovation and commercial execution, as well as accelerate its leadership in the U.S. diagnostics market. Known for its proprietary PHASIFY™ technology and innovation pipeline in cancer and infectious disease diagnostics, PHASE Scientific is now demonstrating its scalable go-to-market strength in North America.
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Source : PR Newswire
