Biodesix Launches GeneStrat Targeted Liquid Biopsy Mutation Test For Patients With Advanced Lung Cancer
22 May 2015 - 12:00AM
Business Wire
Diagnostic Test Reveals Actionable Mutations;
Results Returned Within 72 Hours
Biodesix, Inc. today announced the launch of GeneStrat™, a
targeted liquid biopsy mutation test for genotyping tumors of
patients with advanced non-small cell lung cancer (NSCLC). The
blood test results are available within 72 hours, providing
physicians actionable diagnostic information prior to making
treatment decisions. GeneStrat is focused exclusively on the
clinically actionable EGFR, KRAS, and BRAF mutations often used to
guide targeted therapy treatment decisions. GeneStrat also captures
the EGFR T790M mutation, which can be used for monitoring the
emergence of the primary resistance mutation in the EGFR gene. It
is anticipated that two drugs targeting the resistance mutation may
be available later this year. GeneStrat uses the ddPCR platform to
analyze cell-free tumor DNA and is highly concordant with tissue
analysis, currently considered the gold standard.
Roughly 30% of lung cancer patients either have insufficient
biopsy tissue or are not candidates for a biopsy for tumor mutation
profiling. Even in cases where tissue biopsy is available, the
sense of urgency to treat is great, with one recent study showing
that one out of four patients begin cancer treatment before
receiving mutation test results. Requiring only a blood draw,
GeneStrat offers a fast, minimally invasive alternative to a
high-risk tissue biopsy or re-biopsy in patients with insufficient
tissue.
In addition to providing a minimally-invasive source of mutation
status, liquid biopsy can be more cost-effective than traditional
tissue biopsies. The mean cost of each tissue biopsy is $14,634
across all patients. The cost of a tissue biopsy can be up to four
time higher in the 19.3% of patients who have complications
associated with the biopsy. GeneStrat liquid biopsy can help avoid
the cost and complications of repeat tissue biopsy.
“Being diagnosed within 72 hours of a blood test is critical to
rapid treatment decisions, as over half of people with lung cancer
die within one year of their initial diagnosis,” said David Brunel,
Biodesix’ CEO. “GeneStrat provides the tumor mutation profile at
the time of diagnosis and can be used to monitor resistance by
tracking the rise of the EGFR T790M mutation. For a more complete
picture of the patient’s disease, GeneStrat can also be paired with
VeriStrat®, which captures the host response to the tumor –
prognostic information early in treatment planning and predictive
information for patients who are ineligible for platinum doublet
chemotherapy or after progression on first line treatment. These
tests help physicians offer personalized treatment plans and enable
more informed disease management strategy discussions with
patients, without the need for more invasive and costlier tissue
biopsies.”
Biodesix, VeriStrat and GeneStrat are trademarks or registered
trademarks of Biodesix, Inc. All other trademarks referenced herein
are property of their respective owners.
About Biodesix
Biodesix® is a molecular diagnostics company advancing the
development of innovative blood-based tests – GeneStrat™ and
VeriStrat® - in oncology for precision medicine. The company
provides physicians with diagnostic tests for earlier disease
detection, more accurate diagnosis, disease monitoring and better
therapeutic guidance, which can lead to improved patient outcomes.
Biodesix discovers, develops and commercializes multivariate
protein and genomic diagnostic tests on various discovery
platforms. In addition to developing novel diagnostics
independently, the company partners with biotechnology and
pharmaceutical companies to develop companion diagnostics to
improve utility of therapeutic agents.
For more information about Biodesix, please visit
www.Biodesix.com.
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Chempetitive Group for BiodesixPatrick French,
858-457-2436biodesix@chempetitive.com