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bioAffinity Technologies Awarded U.S. Federal Supply Schedule Contract for CyPath® Lung Test

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bioAffinity Technologies has been awarded a U.S. Federal Supply Schedule contract for its CyPath® Lung test, a noninvasive diagnostic tool for early-stage lung cancer detection. This contract enables the Veterans Health Administration (VHA) and Military Health System to access the test for their patients. The VHA, serving 9.1 million Veterans annually, is the largest integrated healthcare system in the U.S.

Lung cancer is the leading cause of cancer-related death in Veterans, who are 25% more likely to receive a lung cancer diagnosis compared to non-Veterans. The CyPath® Lung test is particularly effective for patients with indeterminate pulmonary nodules detected during low dose computed tomography (LDCT) scans. A recent economic impact study suggests that incorporating CyPath® Lung into the current standard of care could result in significant healthcare cost savings.

bioAffinity Technologies ha ottenuto un contratto del Federal Supply Schedule degli Stati Uniti per il suo test CyPath® Lung, uno strumento diagnostico non invasivo per la rilevazione precoce del cancro ai polmoni. Questo contratto consente alla Veterans Health Administration (VHA) e al Military Health System di accedere al test per i loro pazienti. La VHA, che serve annualmente 9,1 milioni di Veterani, è il più grande sistema sanitario integrato degli Stati Uniti.

Il cancro ai polmoni è la principale causa di morte per cancro tra i Veterani, che hanno una probabilità del 25% maggiore di ricevere una diagnosi di cancro ai polmoni rispetto ai non Veterani. Il test CyPath® Lung è particolarmente efficace per i pazienti con noduli polmonari indeterminati rilevati durante le scansioni di tomografia computerizzata a bassa dose (LDCT). Uno studio recente sull'impatto economico suggerisce che l'integrazione di CyPath® Lung negli attuali standard di cura potrebbe portare a significativi risparmi sui costi sanitari.

bioAffinity Technologies ha sido galardonada con un contrato del Federal Supply Schedule de EE. UU. para su prueba CyPath® Lung, una herramienta de diagnóstico no invasiva para la detección temprana del cáncer de pulmón. Este contrato permite a la Veterans Health Administration (VHA) y al Military Health System acceder a la prueba para sus pacientes. La VHA, que atiende anualmente a 9.1 millones de Veteranos, es el sistema de salud integrado más grande en EE. UU.

El cáncer de pulmón es la principal causa de muerte relacionada con el cáncer entre los Veteranos, quienes tienen un 25% más de probabilidades de recibir un diagnóstico de cáncer de pulmón en comparación con los no Veteranos. La prueba CyPath® Lung es particularmente eficaz para pacientes con nódulos pulmonares indeterminados detectados durante tomografías computarizadas de baja dosis (LDCT). Un estudio reciente sobre el impacto económico sugiere que la incorporación de CyPath® Lung en el estándar actual de atención podría resultar en ahorros significativos en los costos de salud.

bioAffinity Technologies는 미국 연방 공급 일정 계약을 체결하였으며, 그 계약에 따라 비침습적인 조기 폐암 탐지 도구인 CyPath® Lung 테스트를 제공합니다. 이 계약은 Veterans Health Administration (VHA)와 군 의료 시스템이 환자들을 위해 이 테스트를 이용할 수 있도록 합니다. VHA는 매년 910만 명의 재향군인을 서비스하며 미국에서 가장 큰 통합 의료 시스템입니다.

폐암은 재향군인들 사이에서 암 관련 사망 원인 1위로, 재향군인이 비재향군인보다 폐암 진단을 받을 가능성이 25% 더 높습니다. CyPath® Lung 테스트는 저선량 컴퓨터 단층촬영(LDCT) 스캔 중 발견된 불확실한 폐 결절이 있는 환자에게 특히 효과적입니다. 최근 경제적 영향 연구에 따르면 CyPath® Lung을 현재 치료 표준에 통합하면 의료 비용 절감으로 이어질 수 있습니다.

bioAffinity Technologies a reçu un contrat du Federal Supply Schedule des États-Unis pour son test CyPath® Lung, un outil de diagnostic non invasif pour la détection précoce du cancer du poumon. Ce contrat permet à la Veterans Health Administration (VHA) et au Military Health System d'accéder au test pour leurs patients. La VHA, qui sert annuellement 9,1 millions de vétérans, est le plus grand système de santé intégré aux États-Unis.

Le cancer du poumon est la première cause de décès par cancer chez les vétérans, qui ont 25 % plus de chances de recevoir un diagnostic de cancer du poumon par rapport aux non-vétérans. Le test CyPath® Lung est particulièrement efficace pour les patients présentant des nodules pulmonaires indéterminés détectés lors de scans de tomographie par ordinateur à faible dose (LDCT). Une étude récente sur l'impact économique suggère que l'intégration de CyPath® Lung dans le standard de soins actuel pourrait entraîner des économies significatives sur les coûts de santé.

bioAffinity Technologies hat einen Vertrag des U.S. Federal Supply Schedule für ihren CyPath® Lung Test erhalten, ein nicht-invasives Diagnosetool zur frühzeitigen Erkennung von Lungenkrebs. Dieser Vertrag ermöglicht es der Veterans Health Administration (VHA) und dem Military Health System, den Test für ihre Patienten zu verwenden. Die VHA bedient jährlich 9,1 Millionen Veteranen und ist das größte integrierte Gesundheitssystem in den USA.

Lungenkrebs ist die häufigste Todesursache durch Krebs bei Veteranen, die 25% wahrscheinlicher als Nicht-Veteranen mit einer Diagnose von Lungenkrebs konfrontiert werden. Der CyPath® Lung Test ist besonders effektiv für Patienten mit unbestimmten Lungenknoten, die bei Niedrigdosis-Computertomografie (LDCT) Scans entdeckt wurden. Eine aktuelle Studie zu den wirtschaftlichen Auswirkungen legt nahe, dass die Integration von CyPath® Lung in den aktuellen Standard der Versorgung zu erheblichen Einsparungen im Gesundheitswesen führen könnte.

Positive
  • CyPath® Lung test added to U.S. Federal Supply Schedule, expanding access to 9.1 million Veterans
  • Potential for significant healthcare cost savings by reducing unnecessary follow-up procedures
  • Addresses a critical need for early lung cancer detection in high-risk Veteran population
Negative
  • None.

Insights

The addition of CyPath® Lung to the U.S. Federal Supply Schedule marks a significant development in lung cancer detection for Veterans and military personnel. This noninvasive test could potentially improve early-stage lung cancer detection rates among a population with 25% higher risk of diagnosis compared to civilians.

The impact on the Veterans Health Administration (VHA) could be substantial, given that it serves 9.1 million Veterans annually and diagnoses about 8,000 lung cancer cases each year. By providing a less invasive option between LDCT scans and biopsies, CyPath® Lung may help streamline the diagnostic process and potentially reduce healthcare costs.

The economic implications are noteworthy, with a recent study suggesting significant cost savings by incorporating CyPath® Lung into standard care. This aligns with the VA's efforts to improve healthcare efficiency while enhancing patient outcomes. However, the actual adoption rate and long-term impact on veteran health outcomes remain to be seen.

The introduction of CyPath® Lung to the Federal Supply Schedule is a promising development in lung cancer diagnostics, particularly for high-risk populations like veterans. This noninvasive test addresses a critical gap in the current diagnostic pathway, especially for patients with indeterminate pulmonary nodules detected by LDCT scans.

The test's potential to reduce unnecessary invasive procedures is significant. By providing a middle ground between watchful waiting and invasive biopsies, it may lead to earlier detection and treatment initiation for true positives while sparing false positives from risky procedures.

However, it's important to note that while this test shows promise, its real-world performance and impact on patient outcomes in the VA system will need to be closely monitored. The integration of CyPath® Lung into existing lung cancer screening programs like LPOP could potentially enhance the overall effectiveness of early detection efforts in this high-risk population.

Noninvasive diagnostic test for lung cancer available to U.S. Veterans, other federal health services patients

SAN ANTONIO--(BUSINESS WIRE)-- bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer, today announced that CyPath® Lung, its noninvasive test to detect early-stage lung cancer, will be added to the U.S. Federal Supply Schedule, a procurement system that provides the Veterans Health Administration (VHA) and the Military Health System streamlined access to state-of-the-art healthcare products and services.

The VHA, part of the U.S. Department of Veterans Affairs (VA), serves 9.1 million Veterans each year and is the largest integrated health care system in the country, providing care at 1,380 health care facilities, including 170 medical centers and 1,193 outpatient sites of care of varying complexity (VHA outpatient clinics). Approximately 8,000 Veterans are diagnosed and treated for lung cancer annually, according to the VA.

“Lung cancer is the leading cause of cancer-related death in Veterans, despite being one of the most preventable cancers in the world. The University of California, Irvine School of Medicine reports that an estimated 15 Veterans die of lung cancer each day, and Veterans are 25% more likely to receive a lung cancer diagnosis compared to non-Veterans,” bioAffinity President and CEO Maria Zannes said. “My father was one such Veteran who died from lung cancer at age 39. That is just one of many reasons I am immensely proud that VA and Department of Defense physicians will be able to order CyPath® Lung for their patients to help detect early-stage lung cancer with the goal of leading to better treatment and longer lives.”

Retired Col. Roby Joyce, M.D., Medical Director of bioAffinity’s subsidiary laboratory, Precision Pathology Laboratory Services, and a bioAffinity board member, served in the Army Medical Corps for 15 years. “Both as a Veteran who was honored to serve and as the Medical Director for the lab that developed CyPath® Lung to detect this deadly cancer, I am proud to partner with the VA and the Military Health System to help improve health outcomes for the millions of Veterans and active-duty military who are at higher risk for lung cancer,” Joyce said. “It’s incredibly gratifying to see the VA acknowledge CyPath® Lung as a valuable tool for the early diagnosis of lung cancer, which affects far too many past and present members of our military.”

Veterans are at higher risk for lung cancer due to older age, smoking and environmental exposure during and after military service. Through programs like the Lung Precision Oncology Program (LPOP), the VA promotes annual lung cancer screening for high-risk individuals. CyPath® Lung is especially effective for patients who receive a positive screening result. When a low dose computed tomography (LDCT) scan reveals indeterminate pulmonary nodules, CyPath® Lung helps close the gap between a “wait and see” option and an invasive procedure, including biopsy, that may turn out to be unnecessary.

A recent economic impact study found that adding CyPath® Lung to the current standard of care could save hundreds of millions of dollars per year in healthcare costs by reducing follow-up diagnostic assessments, expensive follow-up procedures and procedure-related complications. 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 and Assistant Professor at the University of Texas Health Science Center at San Antonio, were lead co-authors of the study.

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, meso-tetra (4-carboxyphenyl) porphyrin (TCPP), 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 www.cypathlung.com.

About bioAffinity Technologies, Inc.

bioAffinity Technologies, Inc. (Nasdaq: BIAF) 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. For more information, visit www.bioaffinitytech.com and follow us on LinkedIn, Facebook and X.

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 CyPath® Lung for helping to detect early-stage lung cancer with the goal of leading to better treatment and longer lives, adding CyPath® Lung to the current standard of care saving hundreds of millions of dollars per year in healthcare costs by reducing follow-up diagnostic assessments, expensive follow-up procedures and procedure-related complications, and diagnosing and treating early-stage lung cancer improving outcomes and increasing patient survival. 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 ability of CyPath® Lung to aid in helping to detect early-stage lung cancer and to save hundreds of millions of dollars per year in healthcare costs by reducing follow-up diagnostic assessments, expensive follow-up procedures and procedure-related complications 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.

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 is the CyPath® Lung test developed by bioAffinity Technologies (BIAF)?

CyPath® Lung is a noninvasive diagnostic test developed by bioAffinity Technologies to detect early-stage lung cancer. It is particularly effective for patients with indeterminate pulmonary nodules detected during low dose computed tomography (LDCT) scans.

How will the U.S. Federal Supply Schedule contract benefit bioAffinity Technologies (BIAF)?

The contract allows bioAffinity Technologies' CyPath® Lung test to be accessible to the Veterans Health Administration (VHA) and Military Health System, potentially expanding its use to 9.1 million Veterans served annually by the VHA.

Why is the CyPath® Lung test particularly important for Veterans?

Veterans are at higher risk for lung cancer due to older age, smoking, and environmental exposure during and after military service. They are 25% more likely to receive a lung cancer diagnosis compared to non-Veterans, making early detection crucial.

What potential cost savings could the CyPath® Lung test by bioAffinity Technologies (BIAF) provide?

A recent economic impact study suggests that incorporating CyPath® Lung into the current standard of care could save hundreds of millions of dollars per year in healthcare costs by reducing follow-up diagnostic assessments, expensive procedures, and procedure-related complications.

bioAffinity Technologies, Inc.

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