Case Study: bioAffinity Technologies’ Positive CyPath® Lung Result Leads to Detecting Breast Cancer Recurrence
bioAffinity Technologies (NASDAQ: BIAF) released a case study demonstrating how their CyPath® Lung test successfully identified a breast cancer recurrence in an 80-year-old high-risk patient. The test's real-time assessment of lung microenvironment led to the discovery when evaluating indeterminate lung nodules.
The patient, a former smoker with COPD and previous breast cancer history, underwent the test after a CT scan detected an eight-millimeter non-calcified nodule. The CyPath® Lung test's positive result prompted further investigation, leading to a mammogram that confirmed new breast cancer.
A recent study in the Journal of Health Economics Outcomes and Research indicated significant potential cost savings: $2,773 per Medicare patient and $6,460 per private-payer patient if CyPath® Lung were included in standard care. This could amount to total savings of $379 million for Medicare and $895 million for private insurance patients based on 2022 screening numbers.
bioAffinity Technologies (NASDAQ: BIAF) ha pubblicato uno studio di caso che dimostra come il loro test CyPath® Lung abbia identificato con successo una recidiva di cancro al seno in una paziente di 80 anni ad alto rischio. La valutazione in tempo reale del microambiente polmonare ha portato alla scoperta durante la valutazione di noduli polmonari indeterminati.
La paziente, una ex fumatrice con BPCO e una storia di cancro al seno, ha effettuato il test dopo che una TAC aveva rilevato un nodulo non calcificato di otto millimetri. Il risultato positivo del test CyPath® Lung ha spinto a ulteriori indagini, portando a una mammografia che ha confermato un nuovo cancro al seno.
Un recente studio pubblicato nel Journal of Health Economics Outcomes and Research ha indicato significativi potenziali risparmi sui costi: $2,773 per paziente Medicare e $6,460 per paziente con assicurazione privata se il CyPath® Lung fosse incluso nelle cure standard. Ciò potrebbe comportare risparmi totali di $379 milioni per Medicare e $895 milioni per pazienti con assicurazione privata basati sui numeri di screening del 2022.
bioAffinity Technologies (NASDAQ: BIAF) publicó un estudio de caso que demuestra cómo su prueba CyPath® Lung identificó con éxito una recurrencia de cáncer de mama en una paciente de 80 años de alto riesgo. La evaluación en tiempo real del microambiente pulmonar llevó al descubrimiento al evaluar nódulos pulmonares indeterminados.
La paciente, una exfumadora con EPOC y antecedentes de cáncer de mama, se sometió a la prueba después de que una tomografía computarizada detectara un nódulo no calcificado de ocho milímetros. El resultado positivo de la prueba CyPath® Lung llevó a una investigación adicional, que resultó en una mamografía que confirmó un nuevo cáncer de mama.
Un estudio reciente en el Journal of Health Economics Outcomes and Research indicó un ahorro potencial significativo en costos: $2,773 por paciente de Medicare y $6,460 por paciente con seguro privado si se incluyera CyPath® Lung en la atención estándar. Esto podría suponer un ahorro total de $379 millones para Medicare y $895 millones para pacientes con seguro privado basado en los números de detección de 2022.
bioAffinity Technologies (NASDAQ: BIAF)는 그들의 CyPath® Lung 테스트가 80세 고위험 환자에서 유방암 재발을 성공적으로 식별한 사례 연구를 발표했습니다. 폐 미세 환경에 대한 실시간 평가가 불확실한 폐 결절을 평가할 때 발견으로 이어졌습니다.
이 환자는 COPD와 이전 유방암 병력이 있는 전 흡연자로, CT 스캔에서 8mm 비석회화 결절이 발견된 후 테스트를 받았습니다. CyPath® Lung 테스트의 긍정적인 결과는 추가 조사를 촉발하여 새로운 유방암을 확인한 유방촬영술로 이어졌습니다.
최근 Journal of Health Economics Outcomes and Research에 발표된 연구에 따르면 상당한 비용 절감 가능성이 있는 것으로 나타났습니다: 메디케어 환자당 $2,773 및 민간 보험 환자당 $6,460 CyPath® Lung이 표준 치료에 포함될 경우. 이는 2022년 검진 수치를 기반으로 메디케어에서 $379백만 및 민간 보험 환자에서 $895백만의 총 절감액에 이를 수 있습니다.
bioAffinity Technologies (NASDAQ: BIAF) a publié une étude de cas démontrant comment leur test CyPath® Lung a réussi à identifier une récidive de cancer du sein chez une patiente de 80 ans à haut risque. L'évaluation en temps réel du microenvironnement pulmonaire a conduit à la découverte lors de l'évaluation de nodules pulmonaires indéterminés.
La patiente, une ancienne fumeuse avec une BPCO et des antécédents de cancer du sein, a subi le test après qu'un scanner CT ait détecté un nodule non calcifié de huit millimètres. Le résultat positif du test CyPath® Lung a conduit à des investigations supplémentaires, entraînant une mammographie qui a confirmé un nouveau cancer du sein.
Une étude récente publiée dans le Journal of Health Economics Outcomes and Research a indiqué des économies potentielles significatives : 2 773 $ par patient Medicare et 6 460 $ par patient avec assurance privée si CyPath® Lung était inclus dans les soins standard. Cela pourrait représenter des économies totales de 379 millions $ pour Medicare et 895 millions $ pour les patients avec assurance privée sur la base des chiffres de dépistage de 2022.
bioAffinity Technologies (NASDAQ: BIAF) hat eine Fallstudie veröffentlicht, die zeigt, wie ihr CyPath® Lung Test erfolgreich ein Wiederauftreten von Brustkrebs bei einer 80-jährigen Hochrisikopatientin identifiziert hat. Die Echtzeiteinschätzung des Lungenmikroenvironment führte zu der Entdeckung bei der Bewertung von unbestimmten Lungenknoten.
Die Patientin, eine ehemalige Raucherin mit COPD und einer Vorgeschichte von Brustkrebs, unterzog sich dem Test, nachdem ein CT-Scan einen acht Millimeter großen nicht verkalkten Knoten entdeckt hatte. Das positive Ergebnis des CyPath® Lung Tests führte zu weiteren Untersuchungen, die zu einer Mammographie führten, die einen neuen Brustkrebs bestätigte.
Eine aktuelle Studie im Journal of Health Economics Outcomes and Research wies auf erhebliche potenzielle Kosteneinsparungen hin: 2.773 $ pro Medicare-Patient und 6.460 $ pro Privatpatient, wenn CyPath® Lung in die Standardversorgung aufgenommen würde. Dies könnte zu Gesamteinsparungen von 379 Millionen $ für Medicare und 895 Millionen $ für Privatversicherte basierend auf den Screening-Zahlen von 2022 führen.
- CyPath® Lung demonstrated effectiveness in detecting cancer recurrence, expanding its potential use beyond lung cancer
- Significant cost savings potential: $2,773 per Medicare patient and $6,460 per private-payer patient
- Technology reduces need for costly invasive procedures while improving diagnostic accuracy
- None.
Insights
bioAffinity Technologies' case study demonstrates their CyPath® Lung test's expanded utility beyond lung cancer detection. The test successfully identified a breast cancer recurrence in an elderly high-risk patient initially being evaluated for lung nodules. This finding showcases the test's potential broader application in oncological care management.
What makes this particularly significant is how the test appears to offer value as a non-invasive alternative in high-risk cases where traditional diagnostic methods present challenges. For an 80-year-old patient with multiple risk factors (former smoker, COPD history, previous cancer), avoiding invasive procedures represents a meaningful clinical advantage.
The accompanying economic analysis cited in the release estimates substantial cost savings of
However, investors should note this represents a single case study rather than comprehensive clinical trial data. While it demonstrates the test's potential versatility, broader validation through larger studies would be needed to confirm consistent performance across diverse patient populations. The case study format, while valuable for hypothesis generation, provides anecdotal rather than statistical evidence of efficacy beyond the primary indication.
The economic case for bioAffinity's CyPath® Lung diagnostic strengthens with this case study, particularly as it demonstrates potential value beyond its primary lung cancer indication. The cited Journal of Health Economics study quantifies substantial per-patient savings of
For a micro-cap company with approximately
The reduction of invasive procedures represents a significant value proposition in healthcare economics. Each avoided invasive diagnostic procedure not only reduces direct procedural costs but also eliminates potential complications and their associated expenses. Additionally, earlier detection of recurrence typically leads to more cost-effective treatment options.
While no direct revenue projections or commercialization updates were provided, this type of evidence strengthens the company's case to payers and providers. For investors, the expanded utility could potentially increase the addressable market beyond lung cancer screening, though regulatory and reimbursement pathways for broader applications remain undefined in the release. The company will need to translate these promising case studies into widespread clinical adoption to generate meaningful revenue growth.
Case Demonstrates CyPath® Lung’s Potential in Guiding Oncological Care
“This case exemplifies how CyPath® Lung can play a crucial role not only in lung cancer diagnostics but also in broader oncological decision-making, helping to guide clinical strategies and improve patient outcomes while reducing risky invasive procedures,” bioAffinity Technologies’ President and Chief Executive Officer Maria Zannes said.
The patient, a former smoker with COPD who was treated successfully for breast cancer in 2019, was under surveillance for lung cancer due to her history. A routine low-dose CT scan detected indeterminate nodules, including an eight-millimeter non-calcified nodule in her left upper lung lobe. “Given her risk factors and the fact that I’ve been following her with CT scans, this finding was very worrisome,” Gordon H. Downie, MD, PhD, Director of the Pulmonary Nodule Clinic at
Traditional diagnostic approaches presented challenges. A PET scan was unlikely to provide clarity due to the lesion's small size, and serum markers were contraindicated because of her prior cancer. “The CyPath® Lung test afforded me the ability in real time to assess a small nodule in a high-risk patient,” Dr. Downie said. “The result was likely malignant which launched an aggressive, forward-looking diagnostic approach.”
Recognizing the patient's history, her care team conducted a follow-up mammogram, which revealed a new breast cancer confirmed by biopsy.
“Each case study underscores the benefit of adding CyPath® Lung to the standard of care for evaluating indeterminate lung nodules,” Zannes said. “By providing earlier and more accurate diagnostic insights, CyPath® Lung can help reduce the need for costly, invasive follow-up procedures, ultimately lowering healthcare costs while improving patient outcomes. This growing body of evidence strengthens the case for broader adoption of CyPath® Lung, highlighting the significant financial and clinical benefits of our technology.”
A study published in the Journal of Health Economics Outcomes and Research and authored by pulmonologists Michael Morris, MD, and Sheila Habib, MD, found that an average cost savings of
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
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 www.bioaffinitytech.com.
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 playing a crucial role in lung cancer diagnostics and broader oncological decision-making, helping to guide clinical strategies and improve patient outcomes while reducing risky invasive procedures, and adding CyPath® Lung to the standard of care for indeterminate nodules lowering healthcare costs for both Medicare and private payers. 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 increase diagnostic accuracy, lower healthcare costs, 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 cost savings can CyPath® Lung (BIAF) provide for Medicare patients?
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What are the potential cost savings for private insurance patients using BIAF's CyPath® Lung?
How does BIAF's CyPath® Lung test improve the diagnostic process for lung nodules?
