bioAffinity Technologies reported that its CyPath® Lung sputum‑based flow cytometry test sold 146% more units in the first quarter of 2026 than in the same period a year earlier, a jump that the company said reflects growing physician recognition of the test’s noninvasive, high‑accuracy approach to lung cancer risk assessment.
The 92% sensitivity and 88% overall accuracy figures cited by the company are consistent with independent reports of the test’s performance in high‑risk patients with nodules under 20 mm. Management highlighted that the unit‑sales growth “reflects growing recognition of the value that CyPath® Lung brings to clinical decision‑making and patient outcomes,” and added that physicians are increasingly seeking accurate, noninvasive tools to assess lung cancer risk and that the company’s growing body of real‑world evidence supports the test’s clinical utility.
The announcement was met with a positive market reaction, with analysts noting that the 146% growth exceeded internal projections and signals accelerating physician adoption. The company’s market share gains are seen as a key driver of future revenue, while the strong sales momentum also underscores the potential for broader adoption across the U.S. pulmonary nodule management market, which is estimated at $3.58 billion.
Despite the sales surge, bioAffinity remains unprofitable and faces liquidity constraints. Cash and cash equivalents were $0.4 million as of March 31 2025 and rose to $6.5 million by December 31 2025 after a $16.9 million capital raise. The company’s “distressed” classification and ongoing need for capital injections highlight that, while commercial traction is improving, the path to sustainable cash flow and profitability remains uncertain.
CyPath® Lung is marketed as a laboratory‑developed test (LDT) and has not received FDA clearance, which could limit reimbursement and market access. The company is also exploring the use of its platform for asthma and COPD therapeutics, offering potential diversification, but faces competition from other diagnostic providers and the need to navigate regulatory pathways for future products.
Looking ahead, the company’s focus on expanding its commercial footprint and building a robust evidence base positions it to capture a larger share of the growing pulmonary nodule management market. However, continued capital raises and the need to achieve profitability will be critical to sustaining the momentum demonstrated in Q1 2026.
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