bioAffinity Technologies Reports Positive Results from Texas Beta Launch of CyPath® Lung
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 (NASDAQ: BIAF) ha riportato risultati positivi dal lancio beta del suo test CyPath® Lung in Texas, con oltre 600 test effettuati nel 2024. Il test diagnostico per il cancro ai polmoni dell'azienda ha mostrato un'accuratezza del 92% e una specificità dell'87% nei pazienti ad alto rischio con noduli di dimensioni inferiori a 20 millimetri.
Il test è stato aggiunto al Federal Supply Schedule (FSS) degli Stati Uniti, rendendolo disponibile per i veterani e le forze armate attive all'interno dei sistemi sanitari governativi degli Stati Uniti. Uno studio economico sottoposto a peer review ha dimostrato un potenziale risparmio di 379 milioni di dollari per i pazienti Medicare e 895 milioni di dollari per i pazienti con assicurazione privata se il CyPath® Lung fosse stato lo standard di cura nel 2022, rappresentando risparmi per paziente di $2,700 e $6,400 rispettivamente.
L'azienda riporta una crescita delle vendite trimestre dopo trimestre che continua nel 2025, con un'adozione crescente da parte dei medici e delle pratiche polmonari.
bioAffinity Technologies (NASDAQ: BIAF) informó sobre resultados exitosos del lanzamiento beta de su prueba CyPath® Lung en Texas, con más de 600 pruebas realizadas en 2024. La prueba de diagnóstico de cáncer de pulmón de la compañía ha mostrado un 92% de sensibilidad y un 87% de especificidad en pacientes de alto riesgo con nódulos menores de 20 milímetros.
La prueba se ha añadido al Federal Supply Schedule (FSS) de los EE. UU., haciéndola disponible para veteranos y personal militar activo en los sistemas de salud del gobierno de EE. UU. Un estudio económico revisado por pares demostró ahorros potenciales de 379 millones de dólares para pacientes de Medicare y 895 millones de dólares para pacientes con seguro privado si el CyPath® Lung hubiera sido el estándar de atención en 2022, representando ahorros por paciente de $2,700 y $6,400 respectivamente.
La compañía reporta un crecimiento de ventas de trimestre a trimestre que continúa en 2025, con una adopción creciente por parte de médicos y prácticas pulmonares.
bioAffinity Technologies (NASDAQ: BIAF)는 텍사스에서 CyPath® Lung 베타 출시의 성공적인 결과를 보고했으며, 2024년 동안 600건 이상의 검사를 진행했습니다. 이 회사의 폐암 진단 테스트는 92%의 민감도와 87%의 특이도를 보였으며, 20밀리미터 미만의 결절이 있는 고위험 환자들에게 적용되었습니다.
시험은 미국 연방 조달 일정(FSS)에 추가되어 미국 정부의 건강 시스템을 통한 재향 군인 및 현역 군인에게 제공됩니다. 동료 검토를 거친 경제 연구는 CyPath® Lung이 2022년 치료 표준이었다면 Medicare 환자에게 3억 7900만 달러, 민간 보험 환자에게 8억 9500만 달러의 잠재적 절감을 나타내는 것으로 나타났습니다. 이는 각각 환자당 $2,700 및 $6,400의 절감을 의미합니다.
회사는 2025년까지 분기별 매출 성장이 지속되며, 의사 및 호흡기 전문의들에 의해 점점 더 많이 채택되고 있다고 보고했습니다.
bioAffinity Technologies (NASDAQ: BIAF) a rapporté des résultats positifs de son lancement beta du test CyPath® Lung au Texas, avec plus de 600 tests effectués en 2024. Le test de diagnostic du cancer du poumon de l'entreprise a montré 92% de sensibilité et 87% de spécificité chez des patients à haut risque présentant des nodules de moins de 20 millimètres.
Le test a été ajouté au Federal Supply Schedule (FSS) aux États-Unis, le rendant disponible pour les vétérans et le personnel militaire actif au sein des systèmes de santé du gouvernement américain. Une étude économique revêtue de pairs a démontré des économies potentielles de 379 millions de dollars pour les patients Medicare et 895 millions de dollars pour les patients assurés privés si le CyPath® Lung avait été le standard de soins en 2022, représentant des économies de 2 700 $ et 6 400 $ par patient respectivement.
L'entreprise rapporte une croissance des ventes trimestre après trimestre qui se poursuit jusqu'en 2025, avec une adoption croissante par les médecins et les pratiques pulmonaires.
bioAffinity Technologies (NASDAQ: BIAF) berichtete über erfolgreiche Ergebnisse beim Beta-Start seines CyPath® Lung-Tests in Texas, mit über 600 durchgeführten Tests im Jahr 2024. Der Lungenkrebsdiagnosetest des Unternehmens zeigte eine Empfindlichkeit von 92% und eine Spezifität von 87% bei Hochrisikopatienten mit Knoten, die kleiner als 20 Millimeter sind.
Der Test wurde dem Federal Supply Schedule (FSS) der USA hinzugefügt, was ihn für Veteranen und aktive Militärangehörige in den Gesundheitssystemen der US-Regierung verfügbar macht. Eine peer-reviewed wirtschaftliche Studie zeigte ein potenzielles Einsparpotenzial von 379 Millionen Dollar für Medicare-Patienten und 895 Millionen Dollar für privatversicherte Patienten, wenn CyPath® Lung 2022 der Standard der Versorgung gewesen wäre, was Einsparungen pro Patient von 2.700 und 6.400 Dollar darstellt.
Das Unternehmen berichtet von einem anhaltenden Umsatzwachstum von Quartal zu Quartal, das bis ins Jahr 2025 andauert, mit einer zunehmenden Akzeptanz durch Ärzte und Lungenspezialisten.
- Delivered over 600 CyPath® Lung tests in Texas beta launch during 2024
- High diagnostic accuracy with 92% sensitivity and 87% specificity in high-risk patients
- Inclusion in U.S. Federal Supply Schedule (FSS) expanding market to Veterans and military
- Potential cost savings of $379M for Medicare and $895M for private insurance patients
- Quarter-over-quarter sales growth continuing into 2025
- None.
Insights
The beta launch results of CyPath® Lung showcase compelling clinical and commercial potential. The test's 92% sensitivity and 87% specificity for nodules under 20mm is particularly noteworthy, especially considering the detection of early-stage (I and II) lung cancers. The ability to detect multiple cancer types (adenocarcinoma, squamous cell carcinoma and small cell lung cancer) demonstrates broad clinical utility.
The economic analysis revealing potential savings of
For a micro-cap company with a market cap of
The economic benefits demonstrated in the peer-reviewed study provide strong leverage for negotiations with private insurers and healthcare systems. The potential annual savings of
“We are extremely pleased with the exponential growth and our 2024 achievements in delivering a quality diagnostic that makes a difference in patient care. We already see more and more physicians and pulmonary practices incorporating CyPath® Lung into their practices, and we are excited that this year we will launch sales to Veteran and military medical systems,” bioAffinity Technologies President and CEO Maria Zannes said. “The sales growth we saw quarter-over-quarter in 2024 is continuing in 2025 and is supported by the addition of CyPath® Lung to the
Ms. Zannes was recently featured on Nasdaq’s Amplify Spotlight, a series focused on leaders in the small-cap community, where she explained the unique attributes of CyPath® Lung and the strategy for expanding its position in the lung cancer diagnostics market. CyPath® Lung has shown
“In addition to the high sensitivity and specificity of CyPath Lung, physicians reported they were impressed by the findings of the peer-reviewed economic study by two prominent pulmonologists. This study demonstrated total savings of
Michael J. Morris, M.D., Brooke Army Medical Center (BAMC) pulmonology and critical care physician and Assistant Dean of Research at San Antonio Uniformed Services Health Education Consortium (SAUSHEC), and Sheila A. Habib, M.D., Director of the Pulmonary Lung Nodule Clinic and the Lung Cancer Screening Program at the South Texas Veterans Health Care Systems’ Audie L. Murphy Memorial Veterans Hospital were first and second authors on the study published in the Journal of Health Economics and Outcomes Research.
“As more physicians order more CyPath® Lung tests for their patients, doctors are sharing their stories of early detection and the individual patients who are more likely to have a positive outcome despite a diagnosis of lung cancer,” Ms. Zannes said. “Needless to say, this is one of the most gratifying parts of the work we do, and we are looking forward to expanding our marketing effort working with our Key Opinion Leaders in 2025 to grow our market share and improve early diagnosis of lung cancer and provide peace of mind to patients at risk.”
About CyPath® Lung
CyPath® Lung uses 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. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and 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. Diagnosing and treating early-stage cancer can improve outcomes and increase patient survival.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and 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. Research and optimization of the Company’s platform technologies are conducted in its laboratories at Precision Pathology and The University of
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 continued sales growth in 2025, launching sales to Veteran and military medical systems in 2025, and looking forward to working with Key Opinion Leaders in 2025 to expand the Company’s market to improve early diagnosis of lung cancer and provide peace of mind to patients at risk.
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 Company’s ability to continue sales growth in 2025 and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, 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.
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bioAffinity Technologies
Julie Anne Overton
Director of Communications
jao@bioaffinitytech.com
Investor Relations
Dave Gentry
RedChip Companies Inc.
1-800-RED-CHIP (733-2447) or 407-491-4498
BIAF@redchip.com
Source: bioAffinity Technologies, Inc.
FAQ
What are the accuracy rates of BIAF's CyPath® Lung cancer test?
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