bioAffinity Technologies reports more than 1,620 CyPath Lung tests
Nine-month test deliveries more than doubled, while third-quarter CyPath revenue awaits formal results.
Adrian Kessler
More than 1,620 CyPath Lung tests were delivered through the third quarter, over twice the 775 in the comparable 2025 period, as bioAffinity Technologies, Inc. NASDAQBIAF reported on Oct. 6. Its latest disclosed CyPath testing revenue was US$835,000 for the six months ended June 30, so the new test count does not yet establish a third-quarter revenue run rate.
The Oct. 6 update said the number of ordering physicians rose 89 per cent in the third quarter from a year earlier. Physicians who had ordered CyPath Lung through September 2025 increased their sales volume by 48 per cent year over year. The release gave neither a physician count nor CyPath revenue for July through September.
bioAffinity is a San Antonio microcap whose pathology laboratory subsidiary markets a sputum-based test to help assess lung cancer risk in people with suspicious nodules. The company calls CyPath Lung a laboratory-developed test and says it should be used with imaging and other clinical findings.
bioAffinity shares NASDAQBIAF closed at US$6.06 on Nasdaq on Oct. 6, down 2.1 per cent from the previous close, as of 4 p.m. EDT. The company issued its sales update before that trading session.
First-Half Revenue Grew With Testing
The Aug. 7 financial release put CyPath testing revenue at about US$835,000 for the first half of 2026, up from about US$323,000 a year earlier. Test reports delivered in that six-month period rose to 1,097 from 390.
The through-September total is cumulative, just as the 775-test comparison is. More than 1,620 tests delivered through the third quarter does not mean that many were delivered during July through September alone. The Oct. 6 statement also gives no average revenue per test, making it too early to translate the reported growth into a quarterly sales figure.
On June 30, bioAffinity had US$2.4 million in cash, and its second-quarter net loss was US$3.4 million, the Aug. 7 results said. The Oct. 6 release identifies a need for additional capital among its risks; the new test count does not update the cash balance or set a financing timetable.
"One of our objectives for 2026 is executing on our strategy to expand access and drive adoption of CyPath Lung with physicians who have used our test over time," bioAffinity chief executive Maria Zannes said in the Oct. 6 release.
CyPath analyzes cells from a sputum sample using flow cytometry and artificial intelligence. The company says its result indicates whether lung malignancy is likely or unlikely, but the test is not intended as a sole diagnostic tool. Its Aug. 7 release said a longitudinal study had begun enrolling patients at 11 clinical sites; the Oct. 6 commercial update reported no new clinical endpoint.
Read more: bioAffinity Technologies jumps 63 per cent on Hong Kong lung cancer screening patent
Listed Diagnostic Peers Address Different Questions
Biodesix, Inc. NASDAQBDSX describes its Nodify Lung tests as blood-based assessments of a lung nodule's malignancy risk. GRAIL, Inc. NASDAQGRAL markets Galleri as a blood-based, multi-cancer early detection screening test. CyPath addresses an already identified nodule, so those products should not be treated as interchangeable measures of its market share.
Biodesix shares NASDAQBDSX fell 3.79 per cent to US$27.96 on Nasdaq on Oct. 6, as of 4 p.m. EDT. GRAIL shares NASDAQGRAL fell 10.9 per cent to US$137.28 on Nasdaq on Oct. 6, as of 4 p.m. EDT.
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bioAffinity's next formal financial report will cover the quarter ended Sept. 30, though the Oct. 6 release did not set a publication date. That report will show whether the higher test count lifted CyPath revenue and how much cash remained after the June 30 balance of US$2.4 million.
