bioAffinity Technologies announced on January 7, 2026 that its laboratory subsidiary, Precision Pathology Laboratory Services, has successfully maintained its College of American Pathologists (CAP) accreditation. The CAP accreditation is the industry’s gold‑standard quality benchmark, confirming that the laboratory meets rigorous peer‑reviewed standards for accuracy, patient safety, and operational excellence.
The accreditation is a critical enabler for the company’s flagship CyPath Lung test, a sputum‑based flow‑cytometry platform that uses AI to detect early‑stage lung cancer. CAP approval validates the test’s analytical performance and is a prerequisite for Medicare and commercial payer reimbursement, as well as for establishing credibility with health‑system partners and laboratory networks. By maintaining accreditation, Precision Pathology can continue to scale the test without regulatory interruptions and can pursue broader distribution agreements.
The U.S. lung‑cancer diagnostics market is projected to grow from $4.8 billion in 2024 to more than $10 billion by 2034. CyPath Lung differentiates itself from blood‑based liquid biopsies by offering a non‑invasive, sputum‑based alternative that can be performed in a standard clinical laboratory. CAP accreditation strengthens the company’s competitive positioning, making it a more attractive partner for hospitals and insurers seeking validated, high‑quality diagnostic tools in a rapidly expanding market.
Management emphasized the strategic importance of the accreditation. President and CEO Maria Zannes said, “Maintaining CAP accreditation demonstrates our commitment to the highest laboratory standards and reinforces confidence in CyPath Lung as we move toward broader commercialization.” Chief Operating Officer Xavier T. Reveles added, “The accreditation validates our laboratory’s quality and positions us to secure reimbursement and partnership opportunities.” Chief Medical Officer Dr. Gordon Downie noted, “CyPath Lung enhances clinical decision‑making by personalizing care and plays a critical role in refining the diagnostic pathway.”
The accreditation milestone supports bioAffinity’s growth strategy by removing a key regulatory hurdle, enabling the company to focus resources on scaling production, expanding into new markets, and pursuing reimbursement negotiations. While the announcement does not directly impact current revenue, it lays the groundwork for future commercial expansion and payer coverage, which are essential for the company’s long‑term success. The event also signals to investors that bioAffinity’s operational foundation is solid, providing a platform for the company to capitalize on the expanding early‑stage lung‑cancer detection market.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.