CyPath Lung Test Sales Jump 210% as BioAffinity Revenue Rises 19% in Second Quarter
Key Facts
BioAffinity Technologies reported that revenue from its CyPath Lung test rose 210% year over year in the second quarter of 2026 to $474,000, compared with $153,000 in the same period of 2025, according to its quarterly report. The company said the increase was about $321,000, while total revenue rose 19% to $1.5 million from $1.3 million. That means growth in the specialized test outpaced growth in the company’s overall business, with BioAffinity attributing the quarterly increase primarily to CyPath Lung sales. Test sales volume also rose more than 30% from the first quarter of 2026 and more than 200% from the second quarter of 2025, the company said. The figures point to expanding commercial use of the test, while total company revenue remained far below quarterly operating expenses.
Sales growth was accompanied by an expansion in the number of medical providers ordering the test. The company said the number of physicians’ offices and clinics ordering CyPath Lung rose 155% in the second quarter from the same period a year earlier. Its quarterly report also said 622 test results were delivered, compared with 197 in the second quarter of 2025. For the first six months of the year, test revenue reached $835,000, compared with $323,000 in the year-earlier period, an annual increase of 159%. Test revenue was $361,000 in the first quarter, compared with $169,000 a year earlier, showing that the quarterly increase followed growth already recorded before the second quarter.
In the third quarter, the company said CyPath Lung sales continued to rise by more than 100% year to date, without implying comparable growth in consolidated revenue. The number of physicians ordering the test rose 89% from the third quarter of 2025, while sales volume among existing physicians increased 48% year over year. Chief Executive Maria Zannes attributed the increase to broader use of the test in pulmonology and oncology practices, lung nodule clinics and community medical centers. She said the growth “reflects accelerating physician adoption and clinical confidence in our technology,” adding that the company continued to intensify its marketing and physician education efforts. The company also announced a distribution agreement with F Medical, a veteran-owned company, and said the agreement could help expand its access to the government healthcare system, including the Department of Veterans Affairs.
CyPath Lung is a noninvasive test designed to support early detection of lung cancer in high-risk patients. It analyzes cell clusters in sputum using flow cytometry and artificial intelligence. In a published clinical study of high-risk patients with small, indeterminate lung nodules measuring less than 20 millimeters, the test recorded 92% sensitivity, 87% specificity, 88% accuracy and a 99% negative predictive value. The company is also developing investigational sputum tests to measure lung inflammation markers associated with asthma and chronic obstructive pulmonary disease, as well as drug-related receptors. The study included samples from patients with asthma, smokers, people with chronic obstructive pulmonary disease and healthy individuals, and analyzed immune cells by flow cytometry, inflammatory proteins with an ELISA test and pooled data using machine learning. These tests remain in development and are not available for clinical or diagnostic use.
The cost of commercial expansion and liquidity pressure remain prominent factors in the company’s financial position. Operating expenses rose to $4.8 million in the second quarter of 2026 from $3.8 million in the year-earlier period, exceeding consolidated quarterly revenue of $1.5 million. The company’s report showed cash and cash equivalents of about $2.4 million as of June 30, and management concluded that substantial doubt existed about the company’s ability to continue as a going concern for at least 12 months after the financial statements were issued. Management said additional funding would be needed if operating revenue did not increase significantly, and that a lack of financing on acceptable terms could force it to scale back its development plan. On October 9, the company announced the completion of a registered direct offering and private placement with gross proceeds of about $4 million before fees and expenses, with net proceeds to be used for working capital and general corporate purposes.
The company’s shares closed at $2.83 on October 26, after closing at $3.66 on October 20, $3.57 on October 21, $3.17 on October 22 and $2.80 on October 23, according to EL7 data. The company said in September that it had received notice from Nasdaq that it had regained compliance with listing requirements, including the $1 minimum bid price rule. It also said its intellectual property portfolio comprised 22 issued patents and 36 pending applications as of October 8, and that it had received a notice of allowance from the Japan Patent Office for an application related to estimating lung cancer probability using the test. Among upcoming dates listed by the company is a special shareholder meeting on November 20, 2026. It also announced that research data on the test would be presented at the 2026 CHEST meetings on October 20 and 21, with a clinical discussion session on October 21 at 12:30 p.m.