bioAffinity Technologies Expands Government Healthcare Reach Through Distribution Agreement with AvMEDICAL for CyPath Lung
bioAffinity Technologies, Inc., a biotechnology company focused on developing noninvasive diagnostic solutions for the early detection of lung cancer and other pulmonary diseases, has announced a new distribution agreement with AvMEDICAL, a Service-Disabled Veteran-Owned Small Business (SDVOSB) specializing in medical-surgical and laboratory products and services for government agencies.
The agreement is expected to strengthen bioAffinity Technologies’ commercial strategy for CyPath® Lung, its noninvasive urine-based diagnostic test designed to provide physicians with additional information when assessing patients with indeterminate pulmonary nodules. Through the partnership, AvMEDICAL will use its established government procurement channels, contracting expertise, sales infrastructure, and relationships with federal healthcare customers to promote and facilitate access to CyPath Lung.
The collaboration represents an important step in bioAffinity Technologies’ efforts to expand the availability of its diagnostic technology within the U.S. government healthcare market. It also creates an additional pathway through which veterans and other eligible patients receiving care through federal healthcare systems may potentially gain access to CyPath Lung.
Expanding Access Through the Government Healthcare Market
Government healthcare systems represent a significant potential market for diagnostic technologies that can support earlier detection and more efficient management of serious diseases. For bioAffinity Technologies, the agreement with AvMEDICAL provides an opportunity to leverage an established distribution organization rather than developing an entirely new government procurement and sales infrastructure internally.
AvMEDICAL is a Service-Disabled Veteran-Owned Small Business with experience supplying medical-surgical and laboratory products, equipment, and services to government agencies. Its existing relationships and knowledge of federal procurement processes are expected to help simplify the pathway for government healthcare organizations seeking to obtain CyPath Lung.
As part of the agreement, bioAffinity Technologies and AvMEDICAL plan to develop co-branded marketing materials to support awareness of the diagnostic test. AvMEDICAL’s sales organization will also actively promote CyPath Lung to federal customers, including healthcare organizations associated with the U.S. Department of Veterans Affairs (VA).
The collaboration is intended to increase the visibility of CyPath Lung among physicians and healthcare decision-makers while helping bioAffinity expand its presence in the government healthcare supply chain.
Addressing the Challenge of Lung Cancer Detection
Lung cancer remains one of the most serious forms of cancer, and outcomes are strongly influenced by the stage at which the disease is detected. Early diagnosis can provide patients with more treatment options and may improve the possibility of successful intervention.
One of the challenges in lung cancer diagnosis occurs when imaging identifies pulmonary nodules that cannot immediately be classified as benign or malignant. Physicians may need to consider multiple factors and diagnostic approaches before determining the appropriate course of action.
CyPath Lung is designed to provide additional information in this diagnostic pathway. The test can be used alongside imaging and other clinical assessments to help physicians evaluate patients with indeterminate pulmonary nodules.
The technology is intended to offer a noninvasive approach that could contribute information to the overall assessment of lung cancer risk. This may be particularly valuable in situations where physicians are attempting to determine whether a pulmonary nodule requires additional investigation or intervention.
bioAffinity Technologies believes that providing physicians with additional diagnostic information could support more informed decisions for patients undergoing evaluation for possible lung cancer.
Potential Importance for Veterans
The partnership has particular relevance for the veteran population because lung cancer represents a significant healthcare concern within the VA system.
According to information cited by bioAffinity Technologies from the VA, nearly 8,000 veterans are diagnosed with lung cancer each year, while approximately 5,000 veterans die from the disease annually. These figures highlight the continued importance of improving lung cancer detection and management within veteran healthcare.
Maria Zannes, president and CEO of bioAffinity Technologies, said AvMEDICAL’s established presence in the government healthcare marketplace and its experienced sales organization could help broaden the company’s commercial pathway.
Zannes emphasized the potential role of CyPath Lung in assessing lung cancer risk, managing pulmonary nodules, and monitoring individuals who have previously undergone cancer treatment. She also pointed to case studies in which CyPath Lung demonstrated the ability to detect lung cancer at an early stage, including Stage 1A.
The company believes that earlier detection can play a critical role in improving outcomes, and it views the partnership with AvMEDICAL as an opportunity to expand awareness and access to its diagnostic technology among veterans and other patients served by federal healthcare systems.
AvMEDICAL Sees Opportunity to Address an Unmet Diagnostic Need
AvMEDICAL also expressed confidence in the potential of CyPath Lung to complement its existing portfolio of healthcare products and services.
Troy Mizell, president and CEO of AvMEDICAL, described the diagnostic technology as an attractive addition because it addresses an unmet need within the lung cancer diagnostic pathway.
According to Mizell, the company’s understanding of government contracting and the healthcare supply chain could help provide greater value to federal healthcare customers while expanding access to an innovative diagnostic technology.
AvMEDICAL’s status as an SDVOSB is particularly relevant to the government market, where specialized contracting programs and procurement pathways can influence how healthcare products are purchased and distributed. The company also has access to indefinite-delivery, indefinite-quantity (IDIQ) contracts, which can provide government agencies with flexible mechanisms for procuring products and services over time.
By combining this infrastructure with bioAffinity’s diagnostic technology, the two companies aim to create a more efficient commercial pathway for CyPath Lung within government healthcare systems.
CyPath Lung and Pulmonary Nodule Assessment
CyPath Lung is designed as a noninvasive diagnostic test intended to provide physicians with additional information when evaluating patients who have indeterminate pulmonary nodules.
Pulmonary nodules are relatively common findings on medical imaging. While many nodules are benign, some may represent early-stage lung cancer. Determining the appropriate next step can therefore be challenging, particularly when imaging findings do not provide sufficient certainty.
The diagnostic process can involve additional imaging, monitoring over time, invasive procedures, laboratory testing, and other clinical assessments. A noninvasive diagnostic test that provides additional information could potentially support physicians as they navigate these decisions.
CyPath Lung is not intended to replace imaging or other diagnostic tools. Instead, the test is designed to be used in conjunction with imaging and other clinical information as part of a broader evaluation.
According to bioAffinity Technologies, the test may also have applications in monitoring cancer survivorship, potentially providing another tool for physicians managing patients with a history of lung cancer.
Laboratory Testing Performed by Precision Pathology Laboratory Services
CyPath Lung testing is performed by Precision Pathology Laboratory Services (PPLS), a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited laboratory.
PPLS is a wholly owned subsidiary of bioAffinity Technologies and provides the laboratory infrastructure required to process CyPath Lung tests.
The CLIA certification and CAP accreditation are important components of the laboratory’s operational framework. They support the company’s ability to deliver clinical laboratory services while maintaining established standards for laboratory quality and testing processes.
The integration of PPLS within bioAffinity Technologies also gives the company greater control over the laboratory component of the CyPath Lung testing process as it works to expand commercial adoption.
Building Commercial Momentum
The agreement with AvMEDICAL comes as bioAffinity Technologies continues to develop the commercial potential of CyPath Lung. For a biotechnology company focused on diagnostics, establishing effective distribution and reimbursement pathways can be just as important as developing the underlying technology.
Government healthcare systems represent a substantial and strategically important customer segment. However, accessing these systems can require specialized knowledge of procurement procedures, contracting mechanisms, compliance requirements, and established purchasing relationships.
AvMEDICAL’s experience in these areas is expected to help bioAffinity address some of these challenges.
The partnership also allows bioAffinity to expand its commercial reach without relying exclusively on its own sales organization. AvMEDICAL’s sales team will introduce CyPath Lung to its existing federal customer base and help increase awareness of the test among government healthcare decision-makers.
The companies will also collaborate on marketing initiatives, creating educational and promotional materials designed to communicate the potential role of CyPath Lung in the lung cancer diagnostic pathway.
Potential Impact Beyond the VA
Although the VA is an important target customer, the agreement may provide broader opportunities within the federal healthcare market. AvMEDICAL’s government relationships and procurement capabilities could potentially support adoption across multiple agencies and government healthcare organizations.
Expanding access through federal channels could also help bioAffinity reach military personnel, veterans, and other populations receiving care through government-supported healthcare systems.
For patients at risk of lung cancer, greater availability of noninvasive diagnostic tools could potentially support earlier evaluation and more informed clinical decision-making.
At the same time, the companies recognize that diagnostic technologies must be integrated into existing clinical workflows. CyPath Lung is therefore positioned as an additional source of information rather than a replacement for established imaging techniques or other diagnostic procedures.
Strengthening bioAffinity’s Commercial Strategy
The distribution agreement with AvMEDICAL represents a strategic move for bioAffinity Technologies as it works to expand the commercial footprint of CyPath Lung.
By combining bioAffinity’s diagnostic technology and laboratory capabilities with AvMEDICAL’s government contracting expertise, procurement access, and federal healthcare relationships, the companies aim to create a more accessible route for CyPath Lung within the government healthcare market.
For bioAffinity, the partnership could help accelerate awareness and adoption while allowing the company to focus on continued development of its diagnostic portfolio. For AvMEDICAL, CyPath Lung adds a specialized diagnostic technology to its portfolio and provides an opportunity to address an important healthcare need among veterans and government healthcare populations.
Ultimately, the success of the collaboration will depend on physician awareness, clinical adoption, procurement access, and continued demonstration of the utility of CyPath Lung in real-world healthcare settings.
With lung cancer remaining a major cause of cancer-related illness and mortality, the need for tools that can support earlier detection continues to be significant. Through its agreement with AvMEDICAL, bioAffinity Technologies is taking another step toward expanding access to its noninvasive diagnostic technology and strengthening its position in the U.S. government healthcare market.
As commercialization progresses, the company intends to build on the growing interest in CyPath Lung and explore opportunities to make the test more broadly available to physicians and patients who could benefit from additional information when evaluating pulmonary nodules, assessing lung cancer risk, and supporting long-term cancer survivorship.
About AvMedical
AvMEDICAL is a Service-Disabled Veteran-Owned Small Business (SDVOSB) that sources premium medical-surgical and laboratory supplies and equipment from top-tier manufacturers to the government healthcare system. Since 2020, AvMEDICAL has more than doubled its product portfolio to provide enhanced product offerings to its federal government customers. The portfolio covers key categories, including remote cardiac monitoring, ultrasound, advanced bedside monitors, infusion systems, incontinence products for both hospital and home use, and best-in-class laboratory and respiratory testing solutions.
About CyPath Lung
CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells.
In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.
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. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com.