Biodesix Announces Publication of a New Nodify CDT® Clinical Validation Study
Biodesix (NASDAQ: BDSX) announced the publication of a new post-market clinical validation study in CHEST Pulmonary Journal for their Nodify CDT® blood-based lung nodule test. The study, involving 447 patients, reaffirmed the test's performance in detecting lung cancer through blood sample analysis of seven autoantibodies.
Key findings show that 33% of patients with cancerous nodules received diagnoses more than three months after detection when managed conventionally. The study demonstrated the test's high specificity, with very few benign nodules misclassified as high risk. When compared to PET scans in 222 patients, Nodify CDT® showed higher specificity with significantly fewer false positives.
The test is often used alongside Nodify XL2® as part of the Nodify Lung® Nodule Risk Assessment, helping identify appropriate diagnostic pathways for patients with indeterminate lung nodules.
Biodesix (NASDAQ: BDSX) ha annunciato la pubblicazione di un nuovo studio di validazione clinica post-commercializzazione nel CHEST Pulmonary Journal per il loro test per noduli polmonari basato su sangue Nodify CDT®. Lo studio, che ha coinvolto 447 pazienti, ha confermato le prestazioni del test nella rilevazione del cancro ai polmoni attraverso l'analisi del campione di sangue di sette autoanticorpi.
I risultati chiave mostrano che il 33% dei pazienti con noduli cancerosi ha ricevuto una diagnosi più di tre mesi dopo la rilevazione quando gestiti in modo convenzionale. Lo studio ha dimostrato l'elevata specificità del test, con pochissimi noduli benigni classificati erroneamente come ad alto rischio. Rispetto alle PET scans su 222 pazienti, Nodify CDT® ha mostrato una specificità superiore con significativamente meno falsi positivi.
Il test è spesso utilizzato insieme a Nodify XL2® come parte della valutazione del rischio dei noduli polmonari Nodify Lung®, contribuendo a identificare i percorsi diagnostici appropriati per i pazienti con noduli polmonari indeterminati.
Biodesix (NASDAQ: BDSX) anunció la publicación de un nuevo estudio de validación clínica post-comercialización en el CHEST Pulmonary Journal para su prueba para nódulos pulmonares basada en sangre Nodify CDT®. El estudio, que involucró a 447 pacientes, confirmó el rendimiento de la prueba en la detección de cáncer de pulmón a través del análisis de muestras de sangre de siete autoanticuerpos.
Los hallazgos clave muestran que el 33% de los pacientes con nódulos cancerosos recibieron diagnósticos más de tres meses después de la detección cuando fueron manejados de manera convencional. El estudio demostró la alta especificidad de la prueba, con muy pocos nódulos benignos clasificados erróneamente como de alto riesgo. En comparación con las exploraciones PET en 222 pacientes, Nodify CDT® mostró una mayor especificidad con significativamente menos falsos positivos.
La prueba a menudo se utiliza junto con Nodify XL2® como parte de la evaluación de riesgo de nódulos pulmonares Nodify Lung®, ayudando a identificar los caminos diagnósticos apropiados para pacientes con nódulos pulmonares indeterminados.
Biodesix (NASDAQ: BDSX)는 CHEST Pulmonary Journal에 Nodify CDT® 혈액 기반 폐 결절 테스트에 대한 새로운 시장 출시 후 임상 검증 연구 발표를 알렸습니다. 447명의 환자가 포함된 이번 연구는 혈액 샘플 분석을 통해 폐암을 탐지하는 테스트의 성능을 재확인했습니다.
주요 발견에 따르면, 암성 결절이 있는 환자의 33%가 전통적인 방식으로 관리되었을 때, 발견 후 3개월 이상 진단을 받지 못했습니다. 연구는 매우 적은 수의 양성 결절이 고위험으로 잘못 분류된 테스트의 높은 특이성을 입증했습니다. 222명의 환자에서 PET 스캔과 비교했을 때, Nodify CDT®는 현저히 적은 수의 잘못된 긍정으로 더 높은 특이성을 보였습니다.
이 테스트는 종종 Nodify XL2®와 함께 Nodify Lung® 결절 위험 평가의 일환으로 사용되며, 불확실한 폐 결절을 가진 환자에게 적절한 진단 경로를 식별하는 데 도움을 줍니다.
Biodesix (NASDAQ: BDSX) a annoncé la publication d'une nouvelle étude de validation clinique post-commercialisation dans le CHEST Pulmonary Journal pour leur test de nodule pulmonaire basé sur le sang Nodify CDT®. L'étude, impliquant 447 patients, a réaffirmé les performances du test dans la détection du cancer du poumon grâce à l'analyse d'échantillons de sang portant sur sept autoanticorps.
Les résultats clés montrent que 33 % des patients ayant des nodules cancéreux ont reçu leur diagnostic plus de trois mois après la détection lorsqu'ils étaient gérés de manière conventionnelle. L'étude a démontré la forte spécificité du test, avec très peu de nodules bénins classés à tort comme à haut risque. Comparé aux scintigraphies PET chez 222 patients, le Nodify CDT® a montré une spécificité supérieure avec significativement moins de faux positifs.
Le test est souvent utilisé avec le Nodify XL2® dans le cadre de l'évaluation du risque de nodule pulmonaire Nodify Lung®, aidant à identifier les voies diagnostiques appropriées pour les patients présentant des nodules pulmonaires indéterminés.
Biodesix (NASDAQ: BDSX) gab die Veröffentlichung einer neuen post-marketing klinischen Validierungsstudie im CHEST Pulmonary Journal für ihren Nodify CDT® blutbasierten Lungenknoten-Test bekannt. Die Studie, an der 447 Patienten beteiligt waren, bestätigte die Leistung des Tests bei der Erkennung von Lungenkrebs durch die Analyse von Blutproben von sieben Autoantikörpern.
Wichtige Ergebnisse zeigen, dass 33 % der Patienten mit krebsartigen Knoten Diagnosen mehr als drei Monate nach der Entdeckung erhielten, wenn sie konventionell behandelt wurden. Die Studie zeigte die hohe Spezifität des Tests, da nur sehr wenige gutartigen Knoten fälschlicherweise als hochriskant eingestuft wurden. Im Vergleich zu PET-Scans bei 222 Patienten zeigte Nodify CDT® eine höhere Spezifität mit deutlich weniger falsch-positiven Ergebnissen.
Der Test wird häufig zusammen mit Nodify XL2® als Teil der Nodify Lung® Knotenrisikobewertung verwendet und hilft dabei, geeignete diagnostische Wege für Patienten mit unklaren Lungenknoten zu identifizieren.
- Clinical validation study confirms high specificity of Nodify CDT test
- Test demonstrates superior performance compared to PET scans with fewer false positives
- Potential to reduce unnecessary invasive procedures and associated costs
- None.
Insights
The publication of this validation study in CHEST Pulmonary Journal represents a significant clinical milestone for Biodesix's Nodify CDT® test. The study of 447 patients demonstrates superior specificity compared to PET scans, with notably fewer false positives - a critical factor for clinical adoption and reimbursement decisions.
The data revealing that 33% of cancer patients faced diagnostic delays exceeding three months underscores a substantial market opportunity. The test's validated performance in accurately identifying high-risk nodules could accelerate diagnosis timelines and improve patient outcomes, potentially expanding market share in the
Simple explanation: Imagine having a tool that's better than current methods at telling which suspicious spots in lungs are actually cancer. This test proves it can do that with fewer false alarms than expensive PET scans, potentially saving patients from unnecessary procedures and anxiety while helping doctors make faster, more accurate decisions.
This peer-reviewed validation study strengthens Biodesix's market position in two critical ways. First, the demonstrated superior specificity versus PET scans positions the Nodify CDT® test favorably for insurance coverage expansion, as payers increasingly focus on cost-effective diagnostic solutions. Second, the robust clinical data supports broader clinical adoption, particularly important given the test's complementary use with Nodify XL2®.
The 33% delayed diagnosis rate in conventional care represents a compelling commercial opportunity. With approximately 1.6 million new lung nodules detected annually in the US, accelerated market penetration could significantly impact Biodesix's revenue growth. The reduction in false positives compared to PET scans also presents a strong health economics argument for payer adoption.
Analysis of 447 patients receiving the Nodify CDT blood-based lung nodule test published in CHEST Pulmonary Journal reaffirms test performance
LOUISVILLE, Colo., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company with a focus in lung disease, announced a new post-market clinical validation study was published in CHEST Pulmonary Journal that reaffirms the previously established performance of the Nodify CDT® blood-based lung nodule test. Clinical data is one of the foundational pillars driving the success of Biodesix through market adoption and payor coverage of its diagnostic tests.
The Nodify CDT test measures levels of seven autoantibodies associated with lung cancer that can be detected in blood samples of patients with indeterminate lung nodules. Prior studies have demonstrated that elevated levels of the autoantibodies indicate a likely cancerous nodule (referred to as a “rule in” test) and may lead to escalation of care to diagnose lung cancer earlier. The test is often ordered in conjunction with the Nodify XL2® blood-based lung nodule test, designed to identify likely benign nodules (referred to as a “rule out” test). The combination of the two tests, marketed as Nodify Lung® Nodule Risk Assessment, reclassifies the risk of lung cancer to help identify the most appropriate diagnostic pathway.
The newly published study included 447 patients with lung nodules managed conventionally without the use of the Nodify CDT or Nodify XL2 tests. In this cohort,
The primary findings of the study demonstrated that the Nodify CDT test maintained a high specificity, meaning that a very low percentage of benign nodules were misclassified as high risk. The Nodify CDT test performance was also compared to that of positron emission tomography (PET) scans, an imaging modality commonly used to assess lung nodule risk. In the 222 patients receiving PET scans, the Nodify CDT test demonstrated higher specificity, meaning that PET scans had significantly more false positive results. Because PET scans are often used to guide clinical decision making in patients with lung nodules, a false positive can lead to an unnecessary invasive procedure that carries the risk of complications and cost to the patient and healthcare system.
“It is very encouraging to see that the performance of the test is robust in further validation studies,” commented Gerard A. Silvestri, MD, MS, Hillenbrand Professor of Thoracic Oncology at the Medical University of South Carolina. “Clinicians often rely on PET scans for risk classification, but this study demonstrates that the performance of PET alone is insufficient for diagnostic decision making. In comparison, the Nodify CDT test may be a useful adjunct in clinical practice given its high specificity and low false positive rate. The goal of using this rule in test is to avoid delays in getting patients with cancer to definitive treatment options.”
About Biodesix
Biodesix is a leading diagnostic solutions company with five Medicare-covered tests available for patients with lung diseases. The blood-based Nodify Lung® Nodule Risk Assessment, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood-based IQLung™ test portfolio for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS® test, and the VeriStrat® test to support treatment decisions across all stages of lung cancer and expedite personalized treatment. In addition, Biodesix collaborates with the world’s leading biopharmaceutical companies to provide biomarker discovery, diagnostic test development, and clinical trial support services. For more information about Biodesix, visit biodesix.com.
Trademarks: Biodesix, Biodesix Logo, Nodify Lung, Nodify XL2, Nodify CDT, IQLung, GeneStrat, GeneStrat NGS, and VeriStrat are trademarks or registered trademarks of Biodesix, Inc. ddPCR is a trademark of Bio-Rad Laboratories, Inc.
Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. Biodesix has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions. Forward-looking statements may include information concerning the impact of backlog and the timing and assumptions regarding collection of revenues on projections, availability of funds and future capital including under the term loan facility, expectations regarding revenue and margin growth and its impact on profitability, and the impact of a pandemic, epidemic, or outbreak, including the COVID-19 pandemic, on Biodesix and its operations and financial performance. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. The Company's ability to continue as a going concern could cause actual results to differ materially from those contemplated in this press release and additionally, other factors that could cause actual results to differ materially from those contemplated in this press release can be found in the Risk Factors section of Biodesix most recent annual report on Form 10-K, filed March 1, 2024 or subsequent quarterly reports on Form 10-Q during 2024, if applicable. Biodesix undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.
Media:
Natalie St. Denis
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Investors:
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FAQ
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