bioAffinity Shares Surge 31% as CyPath Lung Sales Double and Japan Allows a New Patent

bioAffinity Technologies, Inc. (NASDAQ: BIAF) shares jumped 31.33% to $8.09 by mid-day Thursday, a gain of $1.93 from Wednesday’s $6.16 close. Trading volume reached nearly 29.8 million shares, more than nine times the stock’s average daily volume of about 3.12 million. Two pieces of news drove the move. The company reported that sales of CyPath® Lung, its noninvasive lung cancer test, more than doubled through the third quarter of 2026. This morning, it also announced that the Japan Patent Office plans to grant a patent covering the test and its AI-built algorithm.

Key Points

• CyPath Lung sales rose more than 100% through Q3 2026 compared with the same period in 2025.
• bioAffinity delivered more than 1,620 tests through Q3 2026, up from 775 a year earlier.
• The number of ordering physicians grew 89% year over year in Q3. Physicians who already ordered in 2025 increased their volume by about 48%.
• Japan issued a Notice of Allowance for bioAffinity’s first patent there covering CyPath Lung’s AI-driven algorithm.
• BIAF led today’s PRISM MedTech Index gainers.

bioAffinity (NASDAQ: BIAF) Doubles CyPath Lung Sales Through Q3

bioAffinity Technologies (BIAF) says more doctors are using CyPath Lung, and existing users are ordering more. The 89% rise in ordering physicians shows new doctors are trying the test. The 48% increase from 2025 prescribers shows that doctors keep ordering it after the first time. Sales come mainly from pulmonology and oncology practices, lung nodule clinics and community medical centers.

“One of our objectives for 2026 is executing on our strategy to expand access and drive adoption of CyPath Lung,” said Maria Zannes, President and CEO. She added that the company is well positioned to repeat these results with a larger group of prescribers.

Chief Medical Officer Gordon Downie, MD, PhD, said imaging is finding more lung nodules. Physicians therefore need more information to decide on next steps. He described CyPath Lung as a way to show whether a malignancy is likely or unlikely.

The company is also building a federal sales channel. Earlier this year, bioAffinity signed a distribution agreement with Veteran-Owned AvMEDICAL to reach government healthcare buyers, including the Department of Veterans Affairs. It has also begun extending CyPath Lung toward monitoring lung cancer survivors.

Japanese Patent Allowance Strengthens BIAF’s Patent Position in Asia

On Thursday morning, bioAffinity announced that the Japan Patent Office issued a Notice of Allowance for a patent titled “Detection of Early-Stage Lung Cancer in Sputum Using Automated Flow Cytometry and Machine Learning.” The patent covers a method for predicting the likelihood of lung cancer using CyPath Lung. It is the company’s first patent in Japan for the test’s AI-built algorithm. The patent is expected to issue once the issuance fee is paid.

The allowance builds on the Hong Kong patent PMV covered in September. bioAffinity now holds five patents protecting its early lung cancer test in Asia, including in China and Hong Kong. Across its business, the company has 22 awarded U.S. and foreign patents and 36 pending applications. These cover both its diagnostic platform and its cancer treatment programs.

“The Japanese patent for the CyPath Lung test strengthens and expands the Company’s intellectual property protection,” Zannes said. She added that bioAffinity expects patents in more regions to follow.

How the Test Performs

In a published trial of high-risk patients with lung nodules smaller than 20 millimeters, CyPath Lung showed:

• 92% sensitivity
• 87% specificity
• 88% accuracy
• 99% negative predictive value

The 99% negative predictive value means a negative result rarely misses a cancer. That can help doctors avoid unnecessary invasive procedures.

The test runs as a Laboratory Developed Test at bioAffinity’s subsidiary, Precision Pathology Laboratory Services, under CLIA oversight. It is not meant to be used as the only basis for a diagnosis.

What’s Next for bioAffinity (NASDAQ: BIAF)

The company regained Nasdaq compliance in September. Since then, it has added sales channels and patent coverage, and the Q3 sales figures show doctors are using the test more. Investors will look for these trends to show up when bioAffinity reports full third-quarter financial results. Follow BIAF and its peers on the PRISM MedTech Index.