TEST:

GeneStrat® test

"Biodesix, Inc...today announced that new data was presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, California. These presentations highlight advancements in liquid biopsy technologies that detect cell free DNA (cfDNA) and the clinical value of rapid turnaround time to detect actionable tumor mutations in a real-world clinical setting....An independent presentation of an exploratory analysis from the FLAURA2 clinical study, sponsored by AstraZeneca, was also presented as a plenary session....Results suggest that baseline detection of plasma EGFRm may identify a subgroup of patients who would derive most benefit from the addition of platinum-pemetrexed chemotherapy to osimertinib as first-line treatment for EGFR-mutated advanced NSCLC."

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

In this observational study cohort, cfDNA yields were significantly higher in late-stage NSCLC patients compared to early-stage. We also observed significantly more and varied mutations in plasma from late-stage patients. These initial findings need to be extended to additional cancers and refined by stage at diagnosis.

The high concordance of the independent workflows for the detection of nucleic acid variants in circulation demonstrates the capability of both systems to be used for testing of clinical specimens. Specifically, actionable variants in the four major mutation classes were successfully detected in the reference and test specimen set. As a part of clinical validation, orthogonal testing of variants will need to be conducted.

"Biodesix, Inc...announced the award of a U.S. Federal Supply Schedule contract which includes the Veterans Health Administration providing care for U.S. Veterans and Military Health System providing care for active-duty service members and their families. The contract covers the company’s entire lung diagnostic portfolio: Nodify XL2®, Nodify CDT®, VeriStrat®, GeneStrat® ddPCR, and GeneStrat NGS™ testing."

"Biodesix, Inc...announced that new data were published in the peer-reviewed journal, Diagnostics (Basel), in an article titled, 'Analytic and Clinical Validation of a Pan-Cancer NGS Liquid Biopsy Test for the Detection of Copy Number Amplifications, Fusions and Exon Skipping Variants.' This peer-reviewed publication further validates the GeneStrat NGS test and the use of multiple classes of tumor markers in circulating free nucleic acid analysis as a surrogate for tumor tissue biopsies."

"PierianDx...today announced that it has partnered with Biodesix to provide its interpretation technology platform for use with the Biodesix newly launched GeneStrat NGS™ genomic test, a blood-based tumor profiling test to detect actionable mutations in patients with non-small cell lung cancer (NSCLC)....The IQLung strategy uses genomic profiling to detect actionable mutations in lung cancer, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner."

"Biodesix, Inc...announced today the national launch of its new GeneStrat NGS™ genomic test, a blood-based tumor profiling test. The 52-gene panel includes guideline recommended mutations to help physicians treating advanced- stage lung cancer patients identify targeted therapy mutations, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner...The Company also announced the launch of its new IQLung™ Treatment Guidance Testing Strategy, which includes the new GeneStrat NGS and a broader view of each patient’s disease state."

"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."

P=N/A, N=5000, Recruiting, Biodesix, Inc. | N=1000 --> 5000 | Trial completion date: Dec 2020 --> Dec 2025 | Trial primary completion date: Jun 2019 --> Dec 2025