Latest news with #CyPathLung
Yahoo
22-07-2025
- Business
- Yahoo
Canada Awards New Patent to bioAffinity Technologies for CyPath® Lung, Company's Noninvasive Lung Cancer Diagnostic
New patent protects market expansion to the north where lung cancer is leading cause of cancer deaths SAN ANTONIO, July 22, 2025--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics including CyPath® Lung, the Company's commercially available test for early-stage lung cancer, today announced its patent related to a method to detect lung disease through flow cytometry analysis of sputum has been allowed by the Canadian Patent Office. This patent strengthens the international protection of the Company's diagnostic platform that powers its flagship test, CyPath® Lung. "As with the recent announcement of the award of our patent in China, this Canadian patent reflects our continued execution toward building long-term shareholder value through innovation, protection of our unique assets, and a clear focus on early cancer detection that can save lives," said Maria Zannes, President and CEO of bioAffinity Technologies. Lung cancer is the leading cause of cancer death in Canada, according to the Canadian Cancer Society. In 2024, approximately 31,000 Canadians were diagnosed with lung cancer, and approximately 20,700 people died of the disease. More than 70% of the lung cancer deaths were linked to smoking. "We believe that the award of this patent by the Canadian Patent Office further validates the diagnostic platform behind CyPath® Lung, expands the global footprint of our intellectual property portfolio and highlights the strength of our science," Ms. Zannes said. "Recent case studies highlight CyPath Lung's ability to detect lung cancer at its earliest stages, making our test all the more valuable in Canada where 50% of all lung cancer cases are diagnosed late at Stage IV with the five-year survival rate overall of about 19% in Canada, according to government statistics." The Canadian patent (Patent No. 3,136,245) – titled "System and Method for Determining Lung Health" – protects the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in the sputum. CyPath® Lung is the Company's first commercial product, with clinical study results demonstrating 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. About CyPath® Lung CyPath® Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath® Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company's first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding the benefits to be derived from the patent, the Company's ability to safeguard its intellectual property, and the ability to market CyPath® Lung in Canada. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the benefits to be derived from the patent, the Company's ability to safeguard its intellectual property, and the ability to market CyPath® Lung in Canada, and other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. View source version on Contacts bioAffinity Technologies Julie Anne OvertonDirector of Communicationsjao@ Investor Relations Dave GentryRedChip Companies Inc.1-800-RED-CHIP (733-2447) or 407-491-4498BIAF@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
National Post
22-07-2025
- Business
- National Post
Canada Awards New Patent to bioAffinity Technologies for CyPath® Lung, Company's Noninvasive Lung Cancer Diagnostic
Article content SAN ANTONIO — bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics including CyPath® Lung, the Company's commercially available test for early-stage lung cancer, today announced its patent related to a method to detect lung disease through flow cytometry analysis of sputum has been allowed by the Canadian Patent Office. This patent strengthens the international protection of the Company's diagnostic platform that powers its flagship test, CyPath® Lung. Article content 'As with the recent announcement of the award of our patent in China, this Canadian patent reflects our continued execution toward building long-term shareholder value through innovation, protection of our unique assets, and a clear focus on early cancer detection that can save lives,' said Maria Zannes, President and CEO of bioAffinity Technologies. Lung cancer is the leading cause of cancer death in Canada, according to the Canadian Cancer Society. In 2024, approximately 31,000 Canadians were diagnosed with lung cancer, and approximately 20,700 people died of the disease. More than 70% of the lung cancer deaths were linked to smoking. Article content 'We believe that the award of this patent by the Canadian Patent Office further validates the diagnostic platform behind CyPath® Lung, expands the global footprint of our intellectual property portfolio and highlights the strength of our science,' Ms. Zannes said. 'Recent case studies highlight CyPath Lung's ability to detect lung cancer at its earliest stages, making our test all the more valuable in Canada where 50% of all lung cancer cases are diagnosed late at Stage IV with the five-year survival rate overall of about 19% in Canada, according to government statistics.' Article content The Canadian patent (Patent No. 3,136,245) – titled 'System and Method for Determining Lung Health' – protects the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in the sputum. Article content CyPath® Lung is the Company's first commercial product, with clinical study results demonstrating 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Article content About CyPath® Lung Article content CyPath ® Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath® Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit Article content About bioAffinity Technologies, Inc. Article content bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company's first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit Article content Forward-Looking Statements Article content Certain statements in this press release constitute 'forward-looking statements' within the meaning of the federal securities laws. Words such as 'may,' 'might,' 'will,' 'should,' 'believe,' 'expect,' 'anticipate,' 'estimate,' 'continue,' 'predict,' 'forecast,' 'project,' 'plan,' 'intend' or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding the benefits to be derived from the patent, the Company's ability to safeguard its intellectual property, and the ability to market CyPath ® Lung in Canada. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the benefits to be derived from the patent, the Company's ability to safeguard its intellectual property, and the ability to market CyPath ® Lung in Canada, and other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. Article content Article content Article content Article content Article content Contacts Article content bioAffinity Technologies Article content Article content Julie Anne Overton Article content Article content Director of Communications Article content Article content
Yahoo
20-05-2025
- Business
- Yahoo
BIAF Stock Rises Post Q1 Earnings Despite Revenue Decline
Shares of bioAffinity Technologies, Inc. BIAF have risen 0.04% since the company reported its earnings for the quarter ended March 31, 2025, slightly lagging the broader market, as the S&P 500 Index rose 1.1% over the same period. However, the stock's longer-term performance has been notably weak, with a 54.7% decline over the past month compared to a robust 15.4% increase in the S&P 500. For the first quarter of 2025, bioAffinity reported revenues of $1.9 million, down 22.9% from $2.4 million in the year-ago period. The decline was primarily due to changes in revenue contributions from patient service fees, histology services and medical director fees. Despite the top-line contraction, BIAF's net loss narrowed on a per-share basis to $0.16 compared with a net loss of $0.20 per share in the first quarter of 2024, though the absolute loss widened to $2.7 million from $1.9 million due to a higher share count. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.) Operating expenses increased 2.9% to $4.5 million from $4.4 million in the prior-year quarter. Direct costs and expenses declined 13.1% to $1.4 million from $1.6 million, and R&D expenses fell 6.7% to $367,386 from $393,639. However, clinical development expenses rose sharply from $48,960 to $138,353, reflecting ongoing investments in bioAffinity's pivotal trial strategy. Selling, general and administrative expenses increased 12.2% to $2.5 million from $2.2 million, as the company scaled its commercialization team for CyPath Lung. Sales of bioAffinity's flagship diagnostic, CyPath Lung, surged 276% year over year, reflecting growing market acceptance and operational scaling following the test's 2024 beta launch in Texas. The company emphasized strong demand during the quarter, supported by more than 600 tests delivered in 2024 and continued momentum into 2025. Management attributed the performance to the test's clinical utility, including its ability to detect early-stage lung cancer and prevent unnecessary invasive procedures. The sharp revenue decline appears at odds with the CyPath Lung sales spike, likely indicating a strategic pivot away from low-margin services. This aligns with management's decision to discontinue select pathology services and implement cost-cutting measures expected to save approximately $3.8 million annually. These actions are designed to improve profitability and focus resources on high-margin diagnostics. bioAffinity Technologies, Inc. price-consensus-eps-surprise-chart | bioAffinity Technologies, Inc. Quote CEO Maria Zannes highlighted bioAffinity's operational progress and strategic direction in her remarks. She pointed to a clear focus on commercial execution, including targeted labor reductions and operational changes at the company's subsidiary lab. These efforts are aimed at supporting CyPath Lung's growth while improving the overall cost structure. Zannes also emphasized recent enhancements in CyPath Lung's test processing. Specifically, post-quarter improvements increased data acquisition throughput by 50% and reduced per-test cost by more than 25%, materially enhancing scalability and profitability without compromising clinical performance. bioAffinity ended the quarter with $0.4 million in cash, down from $1.1 million as of Dec. 31, 2024. However, the company has since bolstered its liquidity position, raising $1.4 million through warrant exercises in February and an additional $3.3 million via a public offering in May. These capital raises are expected to support commercialization efforts and ongoing clinical development. bioAffinity did not provide forward-looking financial guidance. However, qualitative commentary suggested a continued strategic pivot toward diagnostics and ongoing expansion of CyPath Lung's market presence. In addition to financial and operational updates, bioAffinity reported progress in strengthening its intellectual property portfolio. During the quarter, the company received acceptance of a patent application from the Australian Patent Office for CyPath Lung. This development enhances the test's international commercialization potential and broadens BIAF's global IP footprint. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report bioAffinity Technologies, Inc. (BIAF): Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
