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) 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.
bioAffinity Technologies (NASDAQ: BIAF) has announced strategic cost-cutting measures expected to save approximately $4 million annually at its subsidiary Precision Pathology Laboratory Services (PPLS). The company is implementing:
- 38% workforce reduction in non-CyPath® Lung personnel at PPLS
- Operational efficiency improvements
- Discontinuation of low-margin pathology services
The restructuring aims to accelerate commercial growth of CyPath® Lung, their noninvasive early-stage lung cancer detection test. While these actions will decrease revenue, they are expected to improve PPLS's profitability by focusing on CyPath® Lung and high-value service lines. The company plans to launch a focused government marketing program next quarter, targeting Veterans Administration and Department of Defense medical centers, following CyPath® Lung's availability through the Federal Supply Schedule.
bioAffinity Technologies (NASDAQ: BIAF) has completed a warrant inducement transaction, raising $1.4 million in gross proceeds. The deal involved four existing accredited investors exercising warrants to purchase 2,438,473 shares of common stock. The company reduced the exercise price of existing warrants from $1.50 to $0.58 per share.
As part of the agreement, investors received new unregistered warrants to purchase up to 2,926,166 shares (120% of exercised shares) with an exercise price of $0.85 per share. These new warrants will become exercisable upon stockholder approval and expire five years after approval. WallachBeth Capital served as the sole placement agent for the transaction.
bioAffinity Technologies (NASDAQ: BIAF) has closed warrant exercise agreements with four accredited investors, generating gross proceeds of $1.4 million. The transaction involves the exercise of existing warrants to purchase 2,438,473 common shares at a reduced exercise price of $0.58 per share (down from $1.50).
In exchange, investors will receive new unregistered warrants to purchase up to 2,926,166 shares (120% of exercised shares) at $0.85 per share. These new warrants will become exercisable upon stockholder approval and expire five years after approval. WallachBeth Capital serves as the sole placement agent for this warrant inducement transaction.
bioAffinity Technologies (NASDAQ: BIAF) has secured approximately $1.4 million in gross proceeds through warrant exercise agreements with three existing accredited investors. The investors will exercise warrants to purchase 2,438,473 common shares at a reduced price of $0.58 per share, down from the original $1.50.
As part of the agreement, investors will receive new unregistered warrants to purchase up to 2,926,168 shares (120% of exercised shares) at $0.85 per share. These new warrants will become exercisable upon stockholder approval and expire five years after approval. The transaction, managed by WallachBeth Capital as sole placement agent, is expected to close on February 26, 2025.
bioAffinity Technologies (NASDAQ: BIAF) has secured warrant exercise agreements with three existing accredited investors, generating $1.4 million in gross proceeds. The agreement involves the exercise of existing warrants for 2,438,473 common stock shares at a reduced price of $0.58 per share (down from $1.50).
In exchange, investors will receive new unregistered warrants to purchase 2,926,168 shares (120% of exercised shares) at $0.85 per share. These new warrants will become exercisable upon stockholder approval and expire five years after approval. The transaction, with WallachBeth Capital as sole placement agent, is expected to close around February 26, 2025.
bioAffinity Technologies (Nasdaq: BIAF; BIAFW), a biotechnology firm, announced that the Australian Patent Office has accepted its patent application for a method of predicting lung cancer using the CyPath® Lung diagnostic test. This patent, titled “Detection of Early-Stage Lung Cancer in Sputum Using Automated Flow Cytometry and Machine Learning,” adds to the company's existing portfolio of 17 awarded U.S. and foreign patents and 38 pending applications. The Australian patent, set to expire in 2042, will be the second awarded for the CyPath® Lung test as a stand-alone assay for lung cancer detection.
The acceptance is seen as a milestone that enhances bioAffinity's market reach and strengthens its potential to improve lung cancer outcomes through earlier detection. The patent will be automatically issued three months after acceptance unless a third party files an opposition. The company believes this intellectual property protection will benefit patients, physicians, shareholders, and the company.
bioAffinity Technologies (NASDAQ: BIAF) reported successful results from its CyPath® Lung beta launch in Texas, with over 600 tests delivered in 2024. The company's lung cancer diagnostic test has shown 92% sensitivity and 87% specificity in high-risk patients with nodules smaller than 20 millimeters.
The test has been added to the U.S. Federal Supply Schedule (FSS), making it available to Veterans and active military across U.S. government health systems. A peer-reviewed economic study demonstrated potential savings of $379 million for Medicare patients and $895 million for privately insured patients if CyPath® Lung had been the standard of care in 2022, representing per-patient savings of $2,700 and $6,400 respectively.
The company reports quarter-over-quarter sales growth continuing into 2025, with increasing adoption by physicians and pulmonary practices.
Enlivex Therapeutics (NASDAQ:ENLV) will be featured on Bloomberg TV's RedChip Small Stocks, Big Money™ show on January 11, 2025, at 7 p.m. ET. CEO Oren Hershkovitz will provide a corporate update focusing on their Allocetra™ platform, a universal, off-the-shelf cell therapy designed to reprogram macrophages.
The company has achieved significant progress with promising Phase I/II clinical trial results in multiple indications, including knee osteoarthritis and psoriatic arthritis. In 2024, Enlivex initiated a multi-country, randomized trial evaluating Allocetra™ in up to 160 patients with moderate to severe knee osteoarthritis, with key data expected by Q3 2025.