Identify your patient’s actionable lung cancer mutations

Guideline-recommended, blood-based mutation results within 72 hours.

 

 

What is the GeneStrat® test?

  • Delivers guideline-recommended1, blood-based mutation results: EGFR, ALK, ROS1, RET, BRAF, and KRAS
  • Results within 72 hours can reduce treatment delays and expedite clinical trial enrollment
  • Drives treatment strategy and facilitates monitoring
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Testing Platform

  • Measures circulating cell-free DNA and RNA using Droplet Digital PCR (ddPCR)
  • Highly sensitive and specific mutation detection
  • Clinically validated
LEARN MORE ABOUT DDPCR TESTING  
THE GENES TESTED IN THE GENESTRAT® TEST ARE COVERED BY MEDICARE AND MANY PRIVATE PAYERS.

Nearly 80% of patients currently do not have mutation results available at their initial oncology consult.
How do we change this paradigm with blood-based testing?

Source: Lim, C., et.al. 2015. Biomarker Testing and Time to Treatment Decision in Patients with Advanced Non-Small Cell Lung Cancer. Ann Oncol first published online April 28, 2015

Save time, Save tissue

BLOOD-BASED RESULTS WITHIN 72 HOURS EXPEDITE TIME TO TREATMENT IN AS

LITTLE AS 8 DAYS2 FROM DIAGNOSTIC BIOPSY.

Tissue-based Tumor Mutation Testing: Presentation to Treatment

GeneStrat Tumor Mutation Testing: Presentation to Treatment


Reference: 1. NCCN Guidelines 2. Bowling, et al. J Clin Oncol 36, 2018 (suppl; abstr e18519) 3. Hagemann, et al. Cancer. 2015;121:631-9. 4. Vidaver RM et al. J Oncol Pract 2016 Jun 3;12(6):e643-53

Accurate, actionable gemonic results

Available Mutations Clinical Sensitivity Clinical Specificity Concordance Treatment Implications
EGFR Sensitizing
del19, L858R
95.8% 100% 98.8% May benefit from treatment with osimertinib, afatinib, erlotinib, or gefitinib
EGFR Resistance
T790M
86.7% 100% 96.4% May benefit from osimertinib if previously treated with 2nd generation EGFR TKIs
EML4-ALK Fusions
1, 2, 3
85.0% 100% 92.0% May benefit from treatment with alectinib, crizotinib, ceritinib, or brigatinib depending on previous therapies
KRAS 
G12C, G12D, G12V
87.9% 100% 96.0% KRAS mutations are associated with poorer prognosis
ROS1* 
CD74, SDC4, SLC34A2, EZR, TPM3
100% May benefit from treatment with crizotinib or ceritinib
RET*
KIF5B, CCDC6, TRIM33
100% May benefit from treatment with cabozantinib or vandetanib
BRAF*
V600E
100% May benefit from dabrafenib + trametinib, vemurafenib, or dabrafenib
GeneStrat
Combined variant results
90.9% 100% 97.0% See implications listed above for each variant

*Clinical sensitivity and specificity were not calculated for ROS1, RET, and BRAF due to availability of samples with rare mutations (ROS1, RET) and treatment-naïve samples (BRAF)
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We are committed to supporting your treatment strategies and improving the lives of patient’s with lung cancer.

SAVE TIME. 72-HOUR TURNAROUND.

SAVE TISSUE. ONE SIMPLE BLOOD DRAW.

TWO SIDES OF CANCER. GENOMIC & PROTEOMIC TESTING.

$0 OUT OF POCKET EXPENSE FOR MEDICARE AND MEDICAID PATIENTS.

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CLICK HERE TO MAKE AN ONLINE KIT REQUEST  

 

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