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TEST:
GeneStrat® test

Company:
Biodesix
Type:
Laboratory Developed Test
Related tests:
Evidence

News

2ms
Enrollment closed
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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VeriStrat® • GeneStrat® test
1year
Prevalence of four major gene mutation classes in a survey of ctDNA recovery from early and advanced stage NSCLC (AACR 2023)
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.
Circulating tumor DNA • Metastases
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GeneStrat® test
1year
Evaluation of two clinically focused targeted NGS systems for liquid biopsy testing shows a high level of concordance in resulting actionable mutations (AACR 2023)
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.
Clinical • Liquid biopsy • Next-generation sequencing • Biopsy • Discordant
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • EML4 (EMAP Like 4) • FGFR (Fibroblast Growth Factor Receptor)
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KRAS mutation • EGFR mutation • BRAF mutation • NRAS mutation • HER-2 mutation • MET exon 14 mutation • EML4-ALK fusion • ALK fusion
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GeneStrat® test • Oncomine Precision Assay
over1year
Biodesix awarded U.S. Federal Supply Schedule contract for its comprehensive lung cancer diagnostic testing solutions (Biodesix Press Release)
"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."
Licensing / partnership • Commercial
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VeriStrat® • GeneStrat® test • Nodify CDT™ • Nodify XL2™
almost2years
Biodesix announces publication further validating the use of liquid biopsies and NGS techniques to provide clinical information for patients with cancer (Biodesix Press Release)
"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."
Clinical data
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GeneStrat® test
2years
PierianDx and Biodesix Partner to Advance Lung Cancer Diagnostics (PierianDx Press Release)
"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."
Licensing / partnership
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GeneStrat® test
2years
Biodesix announces the launch of its GeneStrat NGS™ test and the IQLung™ Testing Strategy with unprecedented time to results (Biodesix Press Release)
"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."
Launch
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GeneStrat® test
over2years
Biodesix partners with Spesana to streamline digital access to molecular diagnostics for precision medicine in lung cancer (Biodesix Press Release)
"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."
Licensing / partnership
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VeriStrat® • GeneStrat® test • Nodify CDT™ • Nodify Lung • Nodify XL2™
3years
INSIGHT: Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects (clinicaltrials.gov)
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
Enrollment change • Trial completion date • Trial primary completion date
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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VeriStrat® • GeneStrat® test