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bioAffinity Technologies Inc (BIAF) delivers pioneering noninvasive diagnostics for early cancer detection through advanced flow cytometry solutions. This dedicated news center provides investors and medical professionals with timely updates on the company’s scientific advancements and strategic growth.
Access official press releases covering regulatory milestones, clinical study results, and partnership agreements. Key focus areas include developments around the CyPath Lung test, licensing expansions, and financial performance reports. Our curated feed ensures you stay informed about BIAF’s contributions to reducing invasive diagnostic procedures in oncology.
Explore updates categorized for clarity: earnings announcements, FDA submissions, collaborative research initiatives, and technological enhancements to cellular analysis platforms. Bookmark this page or check regularly to monitor how bioAffinity’s innovations in cellular oncology are reshaping diagnostic standards.
bioAffinity Technologies (NASDAQ: BIAF) announced the release of a white paper by Dr. Gordon Downie highlighting the real-world impact of CyPath® Lung, their noninvasive sputum-based test for early-stage lung cancer detection. The paper details four clinical cases where CyPath® Lung significantly influenced decision-making for patients with indeterminate pulmonary nodules.
Dr. Downie, Director of the Lung Nodule Clinic at Titus Regional Medical Center, demonstrated how the test helped in various scenarios, including cases with sub-8mm nodules, prior cancer history, post-COVID changes, and previous lung cancer diagnosis. The test serves as an adjuvant after CT and PET imaging, providing additional information about malignancy likelihood in lung nodules, where approximately 98% are benign.
bioAffinity Technologies (NASDAQ: BIAF) has completed a $3.25 million best efforts offering of securities. The offering included 10,156,250 shares of Common Stock (or pre-funded warrants) and warrants to purchase up to 15,234,375 shares of Common Stock (May 2025 Warrants) at a combined public offering price of $0.32 per share and accompanying warrant. WallachBeth Capital LLC served as the sole placement agent for this offering. The offering was conducted through a registration statement on Form S-1 that was previously filed and declared effective by the SEC.
bioAffinity Technologies (NASDAQ: BIAF), a biotechnology company developing noninvasive early-stage cancer detection tests, has closed a $3.25 million offering. The offering included 10,156,250 shares of Common Stock (or pre-funded warrants) at $0.32 per share, along with warrants to purchase up to 15,234,375 additional shares. WallachBeth Capital acted as the sole placement agent for this best efforts offering, which was conducted through a registration statement on Form S-1 previously declared effective by the SEC.
bioAffinity Technologies (NASDAQ: BIAF), a biotechnology company developing noninvasive early-stage cancer detection tests, has announced a $3.25 million offering through WallachBeth Capital LLC. The offering includes 10,156,250 shares of Common Stock (or pre-funded warrants) and warrants to purchase up to 15,234,375 shares of Common Stock. The combined public offering price is set at $0.32 per share with accompanying May 2025 Warrant. The offering is expected to close around May 7, 2025, subject to customary closing conditions. WallachBeth Capital is serving as the sole placement agent for this registered offering.
bioAffinity Technologies (NASDAQ: BIAF) has announced pricing for a $3.25 million securities offering. The offering consists of 10,156,250 shares of Common Stock (or pre-funded warrants) along with warrants to purchase up to 15,234,375 additional shares. The combined public offering price is set at $0.32 per share of common stock (or pre-funded warrant) with accompanying May 2025 Warrant. The offering is expected to close around May 7, 2025, with WallachBeth Capital, LLC serving as the sole placement agent.
bioAffinity Technologies (NASDAQ: BIAF) has announced significant efficiency improvements to its CyPath® Lung cancer detection test. The company has achieved a 50% reduction in data acquisition time and a 60% decrease in sample processing costs. These optimizations are expected to deliver a 10% increase in overall throughput and a 25% decrease in unit cost.
The CyPath® Lung test, which uses flow cytometry and artificial intelligence to detect lung cancer in sputum samples, has demonstrated 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high-risk patients with small lung nodules. A recent economic impact study showed potential cost savings of $2,773 per Medicare patient and $6,460 per privately insured patient if CyPath® Lung is added to the standard of care, potentially saving $379 million and $895 million respectively nationwide.
bioAffinity Technologies (BIAF) reported significant financial results for 2024, with revenue surging 270% to $9.4 million from $2.5 million in 2023. The company's flagship product, CyPath® Lung, saw orders grow by approximately 1,400% over 2023, driven by increased physician adoption and expanded insurance coverage including Medicare reimbursement.
Key achievements include the addition of CyPath® Lung to the U.S. Federal Supply Schedule, providing access to 1,380 government healthcare facilities. The company expanded its physician network by over 300% in 2024. However, for 2025, BIAF projects lower revenue of $6-8 million due to discontinuing unprofitable pathology services.
Financial results show operating expenses of $18.3 million and a net loss of $9.0 million ($0.75 per share) for 2024. Cash position stood at $1.1 million as of December 31, 2024, with an additional $1.4 million raised through warrant exercises in February 2025.
bioAffinity Technologies (BIAF) released a case study highlighting how their CyPath® Lung test successfully detected a second primary lung cancer in a high-risk patient. The 72-year-old patient, with a 50 pack-year smoking history, had previously undergone surgery for stage 1A non-small cell lung cancer in 2023.
The test's positive result led to further investigation, revealing small cell carcinoma distinct from the initial cancer. Dr. Gordon H. Downie, Director of the Pulmonary Nodule Clinic at Titus Regional Medical Center, emphasized the test's value in real-time detection of malignant cells.
A recent study in the Journal of Health Economics Outcomes and Research demonstrated potential cost savings with CyPath® Lung:
- Medicare patients: Average savings of $2,773 per patient ($379 million total)
- Private-payer patients: Average savings of $6,460 per patient ($895 million total)
bioAffinity Technologies (NASDAQ: BIAF) released a case study demonstrating how their CyPath® Lung test successfully identified a breast cancer recurrence in an 80-year-old high-risk patient. The test's real-time assessment of lung microenvironment led to the discovery when evaluating indeterminate lung nodules.
The patient, a former smoker with COPD and previous breast cancer history, underwent the test after a CT scan detected an eight-millimeter non-calcified nodule. The CyPath® Lung test's positive result prompted further investigation, leading to a mammogram that confirmed new breast cancer.
A recent study in the Journal of Health Economics Outcomes and Research indicated significant potential cost savings: $2,773 per Medicare patient and $6,460 per private-payer patient if CyPath® Lung were included in standard care. This could amount to total savings of $379 million for Medicare and $895 million for private insurance patients based on 2022 screening numbers.
bioAffinity Technologies (NASDAQ: BIAF) has released physician case studies demonstrating the effectiveness of their CyPath® Lung noninvasive lung cancer detection test. A notable case study presented by Dr. Gordon H. Downie showed how the test helped avoid unnecessary invasive procedures for an 85-year-old high-risk patient.
The test's 'Unlikely Lung Cancer' result prevented risky biopsies, leading to a successful 'watchful waiting' approach where the patient's nodules resolved within three months. Dr. Downie, Director of the Pulmonary Nodule Clinic at Titus Regional Medical Center, has incorporated CyPath® Lung into his protocol for patients with indeterminate nodules.
A peer-reviewed economic impact study published in the Journal of Health Economics Outcomes and Research revealed significant potential cost savings: $2,773 per Medicare patient (total $379 million) and $6,460 per private-payer patient (total $895 million) if implemented as standard care for positive lung cancer screenings in 2022.