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bioAffinity Technologies, Inc. (NASDAQ: BIAF) is a San Antonio–based development-stage biotechnology company focused on non-invasive, early-stage cancer diagnosis and targeted cancer treatment. Its primary product, CyPath® Lung, analyzes sputum through flow cytometry to detect lung cancer cells, aiming to enhance diagnostic accuracy, reduce unnecessary invasive procedures, and minimize patient anxiety and medical costs.
Corporate Structure
Founded in 2014, bioAffinity operates through two primary divisions:
- Precision Pathology Laboratory Services, which markets CyPath® Lung as a CLIA-certified laboratory-developed test (LDT)
- OncoSelect® Therapeutics, a subsidiary developing porphyrin-based cancer therapies in preclinical studies
Leadership includes:
- Maria Zannes, President and Chief Executive Officer, who has more than 30 years of executive management experience and a background in journalism and energy policy
- J. Michael Edwards, Chief Financial Officer, a certified public accountant with over three decades in financial management across biotechnology firms
- William Bauta, PhD, Chief Science Officer, a medicinal chemist with more than 25 years in drug discovery and development
Cancer Diagnosis by National Cancer Institute
Recent Developments and News
- October 8, 2025: BIAF shares closed at approximately $3.20 on NASDAQ, an increase of 30.61% with a trading volume of 14,467,921.
- October 7, 2025: Filed an 8-K form (items 8.01 and 9.01) without disclosing detailed financials or material events in the summary.
- October 1, 2025: A Schedule 13G was filed, indicating that Bigger Capital Fund L P, Bigger Capital Fund GP, LLC, and District 2 Capital Fund LP together hold 2.89% of outstanding shares.
- LinkedIn post: CyPath® Lung has shown 92% sensitivity and 87% specificity for nodules under 20 mm when used after inconclusive low-dose CT scans.
Financial and Strategic Analysis
bioAffinity is in the early commercialization phase, with a market capitalization in the low single-digit millions. Key metrics (as of September 26, 2025, per Yahoo Finance) include:
| Metric | Value |
|---|---|
| Market Cap | $4.56 million |
| Revenue (TTM) | $7.68 million |
| Net Loss (TTM) | $11.69 million |
| Profit Margin | –152.18% |
| Cash and Equivalents (mrq) | $802.8 thousand |
| Levered Free Cash Flow (TTM) | –$3.47 million |
The company's strategic priorities include the commercialization of CyPath® Lung through partnerships with physicians and the continued development of OncoSelect® Therapeutics. The ongoing expenses in research, development, and marketing have resulted in net losses, which is common among early-stage biotechnology firms.
Market Position and Industry Context
Lung cancer is a leading cause of cancer mortality in the U.S., and current screening methods utilizing low-dose computed tomography (LDCT) are noted for their low positive predictive value. CyPath® Lung aims to address this shortcoming by providing high-throughput flow cytometry analysis of sputum samples. The CLIA certification of its laboratory services positions bioAffinity to serve pulmonary specialists seeking to minimize invasive follow-up procedures. Competition includes other non-invasive diagnostics in development and established imaging protocols, while regulatory frameworks for LDTs are well-defined.
tl;dr
On October 8, 2025, BIAF shares increased by 30.61% to approximately $3.20 following a Form 8-K filing on October 7. A Schedule 13G filed on October 1 revealed 2.89% stakes held by three investment entities. CyPath® Lung continues to demonstrate 92% sensitivity and 87% specificity for small pulmonary nodules. Financially, the company reports $7.68 million in revenue against an $11.69 million net loss (TTM). Near-term focus areas include expanding the adoption of CyPath® Lung and advancing porphyrin-based therapeutics toward preclinical milestones.
