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bioAffinity Technologies Inc. (BIAFW) pioneers noninvasive diagnostic solutions for early cancer detection, with a focus on improving patient outcomes through innovations like its CyPath Lung test. This page aggregates official company announcements, clinical milestones, and strategic developments for stakeholders tracking advancements in precision diagnostics.
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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.
bioAffinity Technologies (BIAF) announces an exclusive live investor webinar and Q&A session scheduled for December 19, 2024, at 4:15 p.m. ET. The event, hosted by RedChip Companies, will feature President and CEO Maria Zannes discussing CyPath® Lung, the company's first product for noninvasive early-stage lung cancer detection. The presentation will highlight how the test improves early detection, increases survival rates, and reduces unnecessary procedures and costs. The company recently secured a U.S. Federal Supply Schedule contract in October 2024, making CyPath® Lung available to veterans and federal health service patients, with expected sales growth in upcoming quarters.
bioAffinity Technologies (BIAF) reports strong growth and expansion plans for 2025, driven by its CyPath® Lung cancer detection test. The company's subsidiary, Precision Pathology Laboratory Services, expects $9.4 million in 2024 revenues, representing over 20% growth compared to 2023 after its acquisition in September 2023.
CyPath® Lung sales showed a remarkable 1,750% increase through November 30 compared to the previous year. Key achievements in 2024 include securing reimbursement, expanding the sales team, gaining access to federal healthcare systems, and operational streamlining. The company anticipates continued growth in 2025 through expanded national market presence and inclusion in the U.S. Federal Supply Schedule, serving the Veterans Health Administration and Military Health System.
bioAffinity Technologies (Nasdaq: BIAF; BIAFW) announced the addition of their noninvasive cancer detection test, CyPath® Lung, to the Federal Supply Schedule (FSS) for the Veterans Health Administration (VHA). This inclusion allows CyPath® Lung to be accessible to the VA's 1,380 healthcare facilities, including over 170 medical centers and 1,000 outpatient sites. The VHA, serving 9.1 million veterans annually, is the largest integrated healthcare system in the U.S. The announcement was made during a joint presentation with FSS officials at the National Association of Veterans’ Research and Education Foundations (NAVREF) meeting. This collaboration aims to improve lung cancer detection and care for veterans, who are at higher risk due to factors like older age, smoking, and environmental exposure. CyPath® Lung aids in bridging the gap between initial screening results and invasive procedures, offering a significant opportunity for bioAffinity Technologies.
bioAffinity Technologies (BIAF) reported Q3 2024 revenue of $2.4 million, with CyPath® Lung test orders showing over 1,300% growth in the first nine months of 2024 compared to full-year 2023. The company expanded its physician network by 75% compared to Q2 2024, now receiving orders from 11 states. CyPath® Lung was added to the U.S. Federal Supply Schedule, providing access to 1,380 government healthcare facilities. The company reported a net loss of $2.0 million ($0.16 per share), an improvement from the $2.3 million loss in Q3 2023. Cash position stood at $0.8 million, with an additional $2.7 million raised through an offering in October 2024.
bioAffinity Technologies (Nasdaq: BIAF) has appointed Dr. William Bauta as Chief Science Officer, succeeding Dr. Vivienne Rebel who retired on Oct. 31, 2024. Dr. Bauta, previously Senior VP of Research and Development since 2016, brings experience from Genzyme and Ilex Products. He has contributed to multiple company inventions and patents, particularly in optimizing CyPath® Lung, their noninvasive early-stage lung cancer detection test. His work has improved test performance, reduced costs, and expanded the company's patent portfolio. Dr. Bauta earned his Ph.D. from the University of Chicago and completed post-doctoral studies at the University of Texas at Austin.
bioAffinity Technologies (Nasdaq: BIAF) has been granted a patent in Japan for its CyPath® Lung diagnostic test method, which predicts lung cancer likelihood. This marks the first patent specifically for CyPath® Lung as a standalone flow cytometry test for lung cancer detection. The patent, titled 'System and Method for Determining the State of Health of the Lungs,' adds to the company's portfolio of 17 awarded patents and 30 pending applications across various regions. The company focuses on developing noninvasive tests for early-stage lung cancer and other lung diseases detection.
WallachBeth Capital announced the closing of bioAffinity Technologies' (Nasdaq: BIAF) $2.6 million registered direct offering and concurrent private placement. The offering included 2,048,294 shares of common stock at $1.30 per share and warrants to purchase up to 2,662,782 shares at $1.50 per share. The warrants will be exercisable upon stockholder approval and expire five years from that date. bioAffinity Technologies plans to use the net proceeds for general corporate purposes and working capital. WallachBeth Capital acted as the sole placement agent for the offering, which was conducted under an effective shelf registration statement. The private placement of warrants was made under exemptions from registration requirements.
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW) has closed a $2.6 million registered direct offering and concurrent private placement. The company sold 2,048,294 shares of common stock at $1.30 per share and issued warrants to purchase up to 2,662,782 shares at an exercise price of $1.50 per share. The warrants will be exercisable upon stockholder approval and expire five years from that date. WallachBeth Capital acted as the sole placement agent. The company plans to use the net proceeds for general corporate purposes and working capital. The offering was made pursuant to an effective shelf registration statement, with a prospectus supplement to be filed with the SEC.
