TEST:

Nodify Lung

Sonali Sethi, Cleveland Clinic, and Dr. Kyle Hogarth, University of Chicago, will review case studies using the Nodify Lung testing strategy through the lens of the patient, detailing the impact that Nodify Lung testing has on the patient experience and their clinical decisions.

"Biodesix, Inc...announced that new data will be presented at the CHEST Annual Meeting 2024 in Boston, Massachusetts on Tuesday, October 8 at 10:20 am ET. The presentation will detail the experience of healthcare providers using the Nodify Lung Nodule Risk Assessment in over 35,000 patients consecutively tested in a real-world clinical setting....At the CHEST conference, 'Use of a blood-based biomarker for indeterminate nodules in community settings,' will be presented by Kathryn Long, MD of the Medical University of South Carolina. It will describe clinical use patterns and national reclassification rates consistent with prior studies, highlighting the high proportion of results that up- or down-classify patients into actionable risk categories with clear, guideline-recommended, diagnostic plans."

P=N/A; Active, not recruiting --> Completed

Nodify Lung is an effective blood test for assessing the risk of malignancy in solitary pulmonary nodules. It enhances diagnostic accuracy when combined with critical thinking and clinical skills. The test improves the detection of malignant nodules, enabling timely diagnosis and treatment of lung cancer.

Corporate Presentation

"Biodesix, Inc...announced...the validation and launch of a new method of collecting blood specimens for Nodify Lung Nodule Risk Assessment testing. The method uses the FDA-cleared Tasso+™ device, a single-use blood lancing device intended for obtaining capillary whole blood samples from a patient’s upper arm."

The Solitary Pulmonary Nodule (SPN) tool by Mayo Clinic is a valuable tool in assessing for malignancy. When used in conjunction with the Nodify blood test, risk of malignancy can be identified, and plans of care can be created based on results. CLINICAL IMPLICATIONS: By identifying risk with both the SPN tool by Mayo Clinic and the Nodify blood test, patients are sent for biopsy and have a diagnosis quickly.

The data showed that participants with a positive PET scan in conjunction with the result of Nodify Lung test ended with a diagnosis of lung cancer. This is suggestive that Nodify Lung test is a useful tool to suggest lung cancer with the providers clinical judgement and PET scan results. CLINICAL IMPLICATIONS: The use of the Nodify Lung test along with PET is a reliable tool to evaluate risk of malignancy and to formulate a diagnosis for the patient.

"Biodesix, Inc...presented original data in four separate poster presentations at the ISPOR (International Society for Pharmaceutical and Outcomes Research) conference, providing evidence of the health economic benefits of the Nodify CDT® and Nodify XL2® tests in the management of pulmonary nodules. The posters, presented May 8-9, 2023, highlighted potential cost savings in both Medicare and commercially insured patient populations with use of the tests."

P=N/A; Enrolling by invitation --> Active, not recruiting | N=1250 --> 842 | Trial completion date: Dec 2023 --> May 2024 | Trial primary completion date: Dec 2023 --> May 2024

"Royal Philips...announced it has teamed up with Biodesix, Inc...to incorporate the results of Biodesix’s Nodify Lung® blood-based lung nodule risk assessment testing into Philips Lung Cancer Orchestrator lung cancer patient management system....Solution adds proteomic analysis of blood-based biomarkers to Philips Lung Cancer Orchestrator to better assess the risk of lung nodule malignancy, enhancing decision-making for diagnosis and treatment."

P=N/A; N=500 --> 1250

"Spesana...and Biodesix Inc...announced today that they have partnered to further streamline and automate the use of molecular diagnostics in clinical workflows across the United States utilizing Spesana’s digital platform solutions for comprehensive lung cancer management...Spesana’s partnership with Biodesix includes a healthcare platform for clinicians that is beyond the various electronic medical records or lab portals. The platform will incorporate electronic ordering of molecular testing including Biodesix’s blood-based Nodify Lung® Nodule Risk Assessment Testing (Nodify XL2® & Nodify CDT ® tests) and IQlung™ Testing (GeneStrat ® ddPCR, GeneStrat NGS™, & VeriStrat ® tests), all part of a Biodesix’s blood-based treatment guidance portfolio with industry-leading turnaround times."