Welcome to our dedicated page for bioAffinity Tech news (Ticker: BIAF), a resource for investors and traders seeking the latest updates and insights on bioAffinity Tech stock.
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW) is a biotechnology company focused on noninvasive diagnostics and early detection of lung cancer and other lung diseases. News about bioAffinity Technologies often centers on its flagship product, CyPath® Lung, a noninvasive sputum-based test that uses advanced flow cytometry and proprietary artificial intelligence to identify cell populations indicating malignancy in high-risk patients.
Investors and clinicians following BIAF news will see updates on clinical performance and real-world use of CyPath® Lung, including case reports where the test has contributed to detecting Stage 1A lung cancer in patients with indeterminate pulmonary nodules and complex diagnostic profiles. Company announcements also describe growing test volumes, reported increases in CyPath® Lung revenues and adoption by physicians, health systems and Veterans Administration medical centers.
Another key news theme is regulatory and quality milestones. bioAffinity Technologies issues releases on the College of American Pathologists (CAP) accreditation status of its wholly owned subsidiary, Precision Pathology Laboratory Services, and on CLIA certification that underpins its laboratory operations. These updates highlight the laboratory’s role in delivering CyPath® Lung and other pathology services with an emphasis on quality, accuracy and patient safety.
News flow also covers intellectual property and platform development, including notifications of allowance for U.S. patents that protect the AI-built algorithm and flow cytometry platform behind CyPath® Lung, and accepted patent applications in jurisdictions such as Australia for systems and methods to determine lung health. In addition, bioAffinity Technologies reports on capital-raising activities, Nasdaq listing compliance, participation in scientific conferences like CHEST and the American Cancer Society National Lung Cancer Roundtable, and presentations that detail research on sample handling and diagnostic performance.
This BIAF news page aggregates these company disclosures, providing a single view of developments in noninvasive lung cancer diagnostics, laboratory quality achievements, patent progress and corporate actions related to bioAffinity Technologies.
bioAffinity Technologies (Nasdaq: BIAF) announced that its wholly owned laboratory, Precision Pathology Laboratory Services (PPLS), has maintained College of American Pathologists (CAP) accreditation after a rigorous on-site inspection, reaffirming laboratory quality, accuracy and patient safety.
The company said PPLS, acquired in September 2023, generates revenue from anatomic and clinical pathology services and supports long-term growth for its noninvasive CyPath® Lung diagnostic, which the company says can detect lung cancer as early as Stage 1A. The release cites a U.S. lung cancer diagnostics market of $4.8 billion in 2024 projected to reach $10.4 billion by 2034 (8.1% CAGR).
bioAffinity Technologies (Nasdaq: BIAF) announced that Chief Medical Officer Gordon Downie, MD, PhD will present a poster at the American Cancer Society National Lung Cancer Roundtable on Dec 8, 2025 highlighting three clinical cases where CyPath® Lung, a noninvasive sputum-based flow cytometry test, identified Stage 1A lung cancer in diagnostically challenging patients.
The poster, "CyPath® Lung in Practice: From Uncertainty to Clarity and Confidence," describes use of CyPath Lung alongside LDCT, PET, risk calculators, bronchoscopy, and serum markers; sessions are scheduled Dec 8, 2025, 2:35–3:15 p.m. ET, and the poster will be available on the company website.
bioAffinity Technologies (Nasdaq: BIAF) reported third quarter 2025 results highlighting strong commercial traction for CyPath® Lung alongside strategic restructuring. Key metrics: CyPath Lung revenues +86% year‑to‑date and tests processed +97% for the first nine months of 2025; Q3 CyPath sales hit a record, up 92% sequentially and 122% year‑over‑year for the quarter. Total revenue declined to $1.5M from $2.4M due to discontinuing unprofitable pathology services. Net loss was $5.1M (loss of $4.74/share), driven partly by warrant fair value expense. Cash was $7.7M at 9/30/2025 after raising $10.4M in gross equity proceeds. Company regained Nasdaq compliance and added a U.S. patent and two board members.
bioAffinity Technologies (Nasdaq: BIAF) reported accelerating month‑over‑month growth for its noninvasive lung cancer test, CyPath® Lung. October 2025 test volume was 111% higher than the 2025 year‑to‑date monthly average and marks more than a twofold increase since the start of 2025. Third‑quarter sales volume rose 95% QoQ. Practices placing multiple orders grew 106% in Q3 and were 67% higher in October versus the 2025 monthly average. Management described steady adoption by pulmonologists, health systems, and VA centers and expects the trend to continue.
bioAffinity Technologies (Nasdaq: BIAF) announced that IP Australia has accepted Australian patent application AU 2019253111 for its platform to assess lung health and predict multiple lung diseases. The application covers methods using flow cytometry with fluorescent probes to detect cellular and molecular signatures in sputum samples. The acceptance adds to bioAffinity’s global estate—18 awarded and 33 pending patents—and complements the company’s flagship CyPath® Lung diagnostic. The patent will be automatically issued three months after acceptance unless a third party files an opposition before issuance.
bioAffinity Technologies (Nasdaq: BIAF) will present research at CHEST 2025 (Oct 19-22) supporting the CyPath® Lung sample collection and transport methods used for its noninvasive lung cancer test.
Rossella Titone, PhD, will present the poster “The Effect of Sputum Storage and Shipping Temperature on Flow Cytometric Outcomes of Sputum-Based Diagnostic Tests” on October 22, 2025 at 10:20 a.m. at poster board #4324. The company said the study validates protocols for home-collected sputum shipped to its lab, with physicians typically receiving results in two days. BioAffinity will be at Booth #2242 and highlighted recent case studies detecting Stage 1A lung cancers.
bioAffinity Technologies (Nasdaq: BIAF) received a notification of allowance from the USPTO for a patent titled “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning.”
The allowed claim covers an AI-built algorithm and automated flow cytometry system that analyzes sputum cell populations and patient age to predict early-stage lung cancer and supports the company’s commercial CyPath® Lung test. The allowance expands bioAffinity’s global estate to 18 awarded and 33 pending patents across multiple jurisdictions.
bioAffinity Technologies (Nasdaq: BIAF; BIAFW) announced it has regained compliance with Nasdaq continued listing requirements as of a letter dated October 14, 2025. Nasdaq confirmed the company meets Listing Rule 5550(a)(2) (minimum $1.00 closing bid) and Listing Rule 5550(b)(1) (minimum $2.5 million stockholders’ equity), allowing its common stock and warrants to continue trading on the Nasdaq Capital Market under BIAF and BIAFW.
Nasdaq also placed the company under a Mandatory Panel Monitor for one year; failure to comply with the Equity Rule during that period could lead to delisting, though the company can request a new hearing with the Nasdaq Listing Qualifications Hearing Panel before any delisting occurs.
bioAffinity Technologies (NASDAQ: BIAF) closed a registered direct offering of 720,000 shares at $2.50 per share on Oct 9, 2025, raising approximately $1.8 million. WallachBeth Capital acted as sole placement agent. The company said it will use net proceeds for working capital, to support expected growing sales of CyPath® Lung, and for general corporate purposes. The shares were offered under a shelf registration on Form S-3 (File No. 333-275608) declared effective Nov 27, 2023. A prospectus supplement describing the offering terms will be filed with the SEC and made available on the SEC website when available.
bioAffinity Technologies (NASDAQ: BIAF) announced on October 9, 2025 that it closed a registered direct offering of 720,000 common shares at $2.50 per share, raising approximately $1.8 million before offering expenses. WallachBeth Capital acted as sole placement agent. The company said net proceeds will be used for working capital, to support expected growing sales of CyPath® Lung, and for general corporate purposes. The shares were offered under a Form S-3 shelf registration declared effective November 27, 2023, and a prospectus supplement describing the offering terms will be filed with the SEC.
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