bioAffinity Technologies, Inc. (BIAF)

bioAffinity Technologies' stock price has experienced significant volatility in the past six months, with a substantial decline. The stock saw a pre-market climb after the company reported a 95% increase in CyPath® Lung sales from the previous quarter and a 97% increase for the first nine months of 2025 compared to the same period in 2024. The company closed a public offering, raising $4.8 million in gross proceeds. A 1-for-30 reverse stock split of its common stock became effective on September 19, 2025. The company reported an EPS of $-4.740, missing analyst estimates by $4.65. Revenue for the quarter was $1.3 million, a decrease from $2.4 million in Q2 2024, primarily due to a strategic decision to discontinue unprofitable pathology services. The company generated $1.9 million in revenue, with CyPath® Lung sales up 276% year-over-year. The acceptance of an Australian patent application for its lung disease detection platform was announced. The company has reported accelerating month-over-month growth in CyPath® Lung test volume.

The provided information does not explicitly detail any specific demand seasonality for bioAffinity Technologies' products and services, although the company has reported increasing demand and accelerating growth in the volume of CyPath® Lung tests.

bioAffinity Technologies is a biotechnology company focused on developing non-invasive diagnostics for early detection of lung cancer and other lung diseases, as well as targeted cancer treatments. Their primary product, CyPath® Lung, is a non-invasive diagnostic test that utilizes flow cytometry technology and AI-driven analysis to examine cell populations in a patient's sputum for characteristics indicative of lung cancer. Clinical studies have demonstrated CyPath® Lung's high sensitivity, specificity, and accuracy in detecting lung cancer in high-risk patients with small lung nodules. The company is also leveraging its platform technology to develop diagnostics for other lung diseases such as COPD and asthma.

Headquartered in San Antonio, Texas, bioAffinity Technologies is actively working to expand the market reach of CyPath® Lung. The company has seen increased adoption of its test by Veterans' hospitals and is expanding its market in the mid-Atlantic region. CyPath® Lung was added to the U.S. Federal Supply Schedule, providing streamlined access for Veterans Health Administration and Military Health System facilities. Furthermore, an Australian patent application for its platform to detect and characterize multiple lung diseases has been accepted, indicating potential international expansion.

bioAffinity Technologies has experienced both positive developments and challenges impacting its brand reputation. The company reported record revenue of $9.4 million in 2024, a 270% increase from 2023, driven by a 1,400% growth in CyPath® Lung orders, reflecting increasing physician adoption. CyPath® Lung gained reimbursement from Medicare and private insurance starting January 1, 2024. The physician network expanded by over 300% in 2024, and the test's inclusion in the Federal Supply Schedule in October 2024 further broadened its accessibility. An economic validation study also highlighted potential significant cost savings by incorporating CyPath® Lung into lung cancer screening. Despite these positive operational advancements, the company's stock price has seen a substantial decline over the past year. The company also reported negative EPS and missed analyst estimates in Q3 2025. A strategic decision to discontinue unprofitable pathology services in Q2 2025 led to a decrease in overall revenue for that quarter. Analysts currently have a "Reduce" consensus rating for the stock.

bioAffinity Technologies has 12 institutional owners and shareholders who collectively hold 274,232 shares, representing 1.64% of the company's stock. Major institutional shareholders include Sabby Management, Llc, Scientech Research LLC, Vanguard Group Inc, Tower Research Capital LLC (TRC), Bank Of America Corp /de/, and UBS Group AG. Insider ownership is notably strong, with insiders holding 39% of the company and showing positive sentiment, having collectively bought $3.70 million worth of shares over the last year across 100 transactions.