Peer-Reviewed Study: bioAffinity Technologies’ CyPath® Lung Test Shows Potential Significant Healthcare Savings by Reducing Unnecessary Follow-Up, Medical Complications and Overdiagnosis
A peer-reviewed economic study published in the Journal of Health Economics and Outcomes Research has found that incorporating bioAffinity Technologies' CyPath® Lung test into the standard care for Medicare patients with positive lung cancer screenings could lead to significant healthcare savings. The study, conducted by researchers from Brooke Army Medical Center and South Texas Veterans Health Care Systems, estimates potential savings of $2,773 per patient, totaling $379 million in 2022.
The savings are attributed to reduced follow-up diagnostic assessments, expensive procedures, and related complications. For private-payer patients, the potential savings are even higher at $6,460 per patient, with a total estimated savings of $895 million if all screened individuals in 2022 were privately insured. The study highlights CyPath® Lung's potential to improve early lung cancer diagnosis while reducing unnecessary procedures and medical complications.
Uno studio economico revisionato da esperti pubblicato nel Journal of Health Economics and Outcomes Research ha scoperto che l'inserimento del test CyPath® Lung di bioAffinity Technologies nella cura standard per i pazienti Medicare con screening positivi per il cancro ai polmoni potrebbe portare a significativi risparmi sanitari. La ricerca, condotta da studiosi del Brooke Army Medical Center e dei Sistemi Sanitari dei Veterani del Sud Texas, stima risparmi potenziali di $2,773 per paziente, per un totale di $379 milioni nel 2022.
I risparmi sono attribuiti alla riduzione delle valutazioni diagnostiche di follow-up, delle procedure costose e delle complicazioni correlate. Per i pazienti con assicurazione privata, i risparmi potenziali sono ancora più elevati, pari a $6,460 per paziente, con un risparmio totale stimato di $895 milioni se tutti gli individui sottoposti a screening nel 2022 avessero avuto un'assicurazione privata. Lo studio sottolinea il potenziale di CyPath® Lung nel migliorare la diagnosi precoce del cancro ai polmoni, riducendo al contempo procedure non necessarie e complicazioni mediche.
Un estudio económico revisado por pares publicado en el Journal of Health Economics and Outcomes Research ha encontrado que incorporar el test CyPath® Lung de bioAffinity Technologies en la atención estándar para pacientes de Medicare con pruebas de detección positiva de cáncer de pulmón podría resultar en significativos ahorros en el cuidado de la salud. El estudio, llevado a cabo por investigadores del Brooke Army Medical Center y de los Sistemas de Salud de Veteranos del Sur de Texas, estima ahorros potenciales de $2,773 por paciente, totalizando $379 millones en 2022.
Los ahorros se atribuyen a la reducción de evaluaciones diagnósticas de seguimiento, procedimientos costosos y complicaciones relacionadas. Para los pacientes de pagadores privados, los ahorros potenciales son aún mayores, alcanzando $6,460 por paciente, con un ahorro total estimado de $895 millones si todos los individuos examinados en 2022 tuvieran seguro privado. El estudio destaca el potencial de CyPath® Lung para mejorar el diagnóstico temprano del cáncer de pulmón mientras reduce procedimientos innecesarios y complicaciones médicas.
동료 검토된 경제 연구가 Journal of Health Economics and Outcomes Research에 발표되었으며, Medicare 환자들에 대한 bioAffinity Technologies의 CyPath® Lung 테스트를 표준 치료에 포함시키는 것이 양성 폐암 스크리닝을 받은 환자에게 상당한 의료 비용 절감으로 이어질 수 있음을 발견했습니다. Brooke Army Medical Center와 South Texas Veterans Health Care Systems의 연구원들이 수행한 이 연구는 한 환자당 $2,773의 잠재적인 비용 절감을 추정했으며, 이는 2022년에 총 $379백만 달러가 됩니다.
이 절감은 추적 진단 평가, 비싼 절차 및 관련 합병증의 감소에 기인합니다. 민간 보험 환자의 경우, 잠재적인 절감액은 환자당 $6,460로 더욱 높아지며, 2022년에 스크리닝을 받은 모든 개인이 민간 보험에 가입했다면 총 $895백만 달러의 절감 효과를 기대할 수 있습니다. 이 연구는 CyPath® Lung이 조기 폐암 진단을 개선하면서 불필요한 절차와 의학적 합병증을 줄일 수 있는 잠재력을 강조합니다.
Une étude économique évaluée par des pairs publiée dans le Journal of Health Economics and Outcomes Research a révélé que l'intégration du test CyPath® Lung de bioAffinity Technologies dans les soins standards pour les patients Medicare ayant des dépistages positifs du cancer du poumon pourrait entraîner des économies substantielles en matière de santé. L'étude, réalisée par des chercheurs du Brooke Army Medical Center et des Systèmes de Soins de Santé des Anciens Combattants du Sud du Texas, estime des économies potentielles de $2,773 par patient, totalisant $379 millions en 2022.
Les économies sont attribuées à la réduction des évaluations diagnostiques de suivi, des procédures coûteuses et des complications associées. Pour les patients avec assurance privée, les économies potentielles sont encore plus élevées, atteignant $6,460 par patient, avec une économie totale estimée à $895 millions si tous les individus dépistés en 2022 étaient assurés par le privé. L'étude souligne le potentiel de CyPath® Lung pour améliorer le diagnostic précoce du cancer du poumon tout en réduisant les procédures non nécessaires et les complications médicales.
Eine peer-reviewed wirtschaftliche Studie, veröffentlicht im Journal of Health Economics and Outcomes Research, hat festgestellt, dass die Integration des CyPath® Lung-Tests von bioAffinity Technologies in die Standardversorgung für Medicare-Patienten mit positiven Lungenkrebs-Screenings zu erheblichen Einsparungen im Gesundheitswesen führen könnte. Die Studie, die von Forschern des Brooke Army Medical Center und des South Texas Veterans Health Care Systems durchgeführt wurde, schätzt die potenziellen Einsparungen auf $2,773 pro Patient, insgesamt $379 Millionen im Jahr 2022.
Die Einsparungen werden durch reduzierte Folgediagnosetests, kostspielige Verfahren und verwandte Komplikationen erreicht. Bei privat versicherten Patienten sind die potenziellen Einsparungen mit $6,460 pro Patient sogar noch höher, mit einer geschätzten Gesamteinsparung von $895 Millionen, falls alle 2022 gescreenten Personen privat versichert waren. Die Studie hebt das Potenzial von CyPath® Lung hervor, die frühzeitige Diagnose von Lungenkrebs zu verbessern und gleichzeitig unnötige Verfahren und medizinische Komplikationen zu reduzieren.
- Potential savings of $2,773 per Medicare patient and $6,460 per private-payer patient
- Estimated total healthcare savings of $379 million for Medicare patients and $895 million for privately insured patients in 2022
- CyPath® Lung test demonstrates high sensitivity, specificity, and accuracy in lung cancer detection
- Potential to reduce unnecessary follow-up procedures and related medical complications
- Noninvasive and easy-to-use test for patients
- None.
Insights
The economic study on CyPath® Lung presents a potentially significant financial impact on healthcare costs. With projected savings of
However, investors should note that these are projected savings, not direct revenue for the company. The actual financial benefit to bioAffinity Technologies will depend on factors such as market adoption, pricing strategy and reimbursement rates. The Medicare payment set by CMS for CyPath® Lung's specific CPT code will be important in determining the test's profitability.
While the potential cost savings are impressive, it's essential to consider the market penetration required to achieve these figures and the competitive landscape in lung cancer diagnostics. The study's credibility, backed by respected medical professionals and published in a peer-reviewed journal, adds weight to these projections, potentially positively influencing investor sentiment and market adoption.
The CyPath® Lung study highlights a significant advancement in lung cancer diagnostics. The test's potential to reduce unnecessary follow-ups and complications addresses a critical gap in current screening protocols. With a high sensitivity, specificity and accuracy, CyPath® Lung could become an essential tool in the diagnostic pathway.
The study's focus on patients with pulmonary nodules between 6 to 29 millimeters is particularly noteworthy, as this size range often presents diagnostic challenges. By providing clearer guidance for these indeterminate cases, CyPath® Lung could streamline the diagnostic process, potentially leading to earlier detection and treatment of lung cancer.
However, it's important to note that while the economic model is compelling, real-world clinical outcomes data will be necessary to fully validate the test's impact on patient care and survival rates. The non-invasive nature of the test and its potential to reduce medical complications are significant advantages that could drive adoption among both patients and healthcare providers.
The economic evaluation of CyPath® Lung presents a compelling case for healthcare policy consideration. By potentially reducing unnecessary procedures and their associated complications, this test aligns with the broader goals of value-based healthcare and cost containment in the US healthcare system.
The study's differentiation between Medicare and private insurance savings is particularly relevant for policy discussions. The
However, policymakers will need to consider the broader implications of integrating such a test into standard care protocols. This includes evaluating the potential impact on health disparities, ensuring equitable access and assessing the long-term effects on lung cancer mortality rates. The involvement of military and veterans' healthcare professionals in the study may also influence discussions about implementing this technology in government-run healthcare systems.
Study by BAMC’s Michael Morris, M.D., and VA’s Sheila Habib, M.D., evaluated potential economic impact of CyPath® Lung for the early detection of lung cancer
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
The study found that adding CyPath® Lung to the standard of care for private-payer patients with a positive lung cancer screening result could have saved even more, an average of
“Our study suggests the potential for a very positive economic impact on healthcare costs with the widespread use of CyPath® Lung in the early diagnosis of lung cancer,” Dr. Morris said. “CyPath® Lung closes a widely recognized gap in the screening and diagnosis of lung cancer. From the patient perspective, it is noninvasive and easy to use. From the physician perspective, CyPath® Lung’s demonstrated high sensitivity, specificity and accuracy give us a clearer picture of how to proceed.”
“Most important, integrating companion tests like CyPath® Lung into the standard of care for high-risk patients has the potential to help us diagnose lung cancer earlier when treatment is more effective, saving or extending lives,” Dr. Habib said. “The study demonstrates CyPath® Lung’s potential to improve outcomes by reducing delays in diagnosis and reducing both the number of unnecessary procedures and any medical complications they could cause.”
Since the National Lung Cancer Screening Trial (NLCST) released initial findings in 2010, multiple studies similarly concluded that annual screening by low dose computed tomography (LDCT) for high-risk patients reduces lung cancer mortality. But LDCT also has a relatively low positive predictive value, and there is often not a clear diagnostic recommendation for smaller, indeterminate pulmonary nodules. The common choices are to “wait and see” what the next scan reveals or proceed with an invasive procedure, including biopsy, that may turn out to be unnecessary.
The economic model used in the Morris, et al., study evaluated the impact of adding CyPath® Lung to the diagnostic pathway for individuals with a positive LDCT, including patients with a primary lung cancer diagnosis. Cost calculations included procedure expenses, the cost of complications and adverse events due to a procedure, and diagnostic assessment costs.
The study considers the likelihood of clinicians’ use of five specific follow-up procedures based on published, peer-reviewed studies (CT, positron emission tomography (PET), CT-guided biopsy, bronchoscopy, and surgical biopsy), the documented rate of complications for each procedure, and the cost of post-procedure diagnostic assessments. The most common complications included pneumothorax, pneumothorax requiring a tube, and hemorrhage.
The economic model for the study assumed two cohorts: one in which all patients were covered by Medicare and one in which all patients were covered by commercial insurance. The total savings related to each cohort are not additive. An independent and validated source for the percentage of patients who had Medicare, private insurance or a combination of insurance coverage in 2022 was not available for the analysis.
Base prices for the Medicare analysis were based on Medicare 2023 national payment data by Current Procedural Terminology (CPT) codes, and costs for the private payer analysis were determined by using a 2.64 multiplier. The Medicare payment set by the Centers for Medicare and Medicaid Services (CMS) for the CPT code specific to CyPath® Lung was used in the study. The projected cost savings reported in the study are primarily due to reductions in follow-up diagnostic procedures after adding CyPath® Lung to the diagnostic pathway between screening and diagnostic follow-up procedures. bioAffinity Technologies funded the work of Avalon Health Economics. Dr. Morris and Dr. Habib were not compensated for their work on the study.
The views expressed in this press release do not necessarily reflect the official policy or position of the Defense Health Agency, the Department of Defense, the Veterans Health Administration, the Department of Veterans Affairs or any other government agencies.
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
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 the potential economic impact of adding CyPath® Lung to the standard of care for patients with a positive lung cancer screening for an average of
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Julie Anne Overton
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FAQ
What are the potential cost savings of using CyPath® Lung test for Medicare patients with positive lung cancer screenings?
How much could private-payer patients save with the CyPath® Lung test for lung cancer detection?
What are the main benefits of using CyPath® Lung test in lung cancer screening?
Who conducted the economic study on CyPath® Lung test by bioAffinity Technologies (BIAF)?
