CyPath® Lung Sales Surge 200%: 3,000 Tests Mark Growing Acceptance

For healthcare providers managing the growing number of patients found with suspicious lung nodules on screening CT scans, the decision between invasive biopsy and watchful waiting carries significant risks. bioAffinity Technologies' CyPath® Lung offers a noninvasive sputum test that can help triage these cases, and its recent commercial acceleration—doubling sales year-over-year and gaining repeat orders from physicians—suggests it is meeting a critical clinical need. As lung cancer screening guidelines expand and incidental findings rise, the diagnostic market for such tools is poised to expand, making early adoption data a key indicator of long-term value.

bioAffinity Technologies announced a milestone in the commercialization of its CyPath® Lung test, with sales more than doubling year-over-year in the second quarter of 2026. According to the company, Q2 2026 test volume grew over 200% compared to Q2 2025 and rose more than 30% sequentially from Q1 2026, bringing the total number of tests performed since launch to nearly 3,000. The announcement, distributed via a Businesswire press release, provides the most concrete evidence yet that the noninvasive sputum-based diagnostic is gaining meaningful traction among clinicians evaluating patients with indeterminate pulmonary nodules.

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According to the company, Q2 2026 test volume grew over 200% compared to Q2 2025 and rose more than 30% sequentially from Q1 2026, bringing the total number of tests performed since launch to nearly 3,000.

This acceleration matters because lung cancer remains the leading cause of cancer death globally, and the clinical pathway for suspicious nodules detected on CT scans is fraught. Low-dose CT screening for high-risk individuals has expanded dramatically, yet the vast majority of nodules prove benign. The challenge of distinguishing malignant from benign nodules without resorting to invasive biopsy or surgical resection drives demand for noninvasive triage tools. CyPath® Lung uses flow cytometry to analyze cellular biomarkers in sputum, aiming to provide a risk assessment that helps pulmonologists decide whether to pursue invasive diagnostics or continue surveillance. The test operates as a Laboratory Developed Test (LDT) under CLIA regulations, which means it is already commercially available without FDA premarket clearance—a pathway that, while debated, allows earlier market entry.

The commercial update emphasizes that adoption is broadening beyond initial curiosity. CEO Maria Zannes highlighted that “physicians who try CyPath® Lung appreciate its benefits and continue to use it,” indicating that repeat ordering is becoming a pattern. This stickiness is critical for a diagnostic test; it suggests that clinicians are integrating the result into clinical decision-making, not merely experimenting. The customer base now spans pulmonology practices, lung nodule clinics, academic medical centers, and Veterans Affairs facilities. The VA presence is noteworthy because the VA health system is a large, integrated network with a high burden of lung cancer among veterans, making it a potentially influential reference account.

From a market perspective, the addressable population of patients with indeterminate nodules is vast and growing. The U.S. Preventive Services Task Force expanded lung cancer screening eligibility in 2021, and incidental findings from cardiac CT and abdominal imaging add millions more nodule evaluations annually. CMO Gordon Downie underscored this trend, stating that the number of diagnosed indeterminate nodules is expected to grow significantly. For bioAffinity, which has a market capitalization of only a few tens of millions, capturing even a modest share of this market could transform its revenue base. However, the competitive landscape is crowded: liquid biopsy companies like Guardant Health and Exact Sciences are developing blood-based early detection assays with large clinical studies and substantial warchests. CyPath’s sputum-based approach offers a different biological window—airway shed cells—which may complement rather than compete directly with blood-based tests, but payer coverage and guideline endorsement will be decisive.

The 200%+ YoY growth figure is eye-catching but must be contextualized. The company has not disclosed absolute revenue or test numbers per quarter, only percentage changes and cumulative total. This opacity is common for early-stage diagnostics firms protecting competitive intelligence, but it limits external validation. The “nearly 3,000 tests” figure since launch suggests a still-modest baseline—if we assume launch occurred roughly in mid-2024, the quarterly run rate may still be in the low hundreds. Nevertheless, the steep growth trajectory implies that physician awareness campaigns and sales force expansion are yielding results. The sequential 30% quarter-over-quarter increase supports a bullish near-term outlook, provided the trend holds.