Our Genomic Technologies

Droplet Digital PCR (ddPCR™)*

Droplet Digital PCR (ddPCR™) is an ultra-sensitive PCR technique founded on the precise partitioning of DNA into microdroplets. ddPCR testing enables us to pinpoint genetic mutations across various specimen types, including plasma cell-free DNA and RNA, tissue, and cells. ddPCR testing also offers exceptional sensitivity, cost-effectiveness, and rapid results. Whether you require custom assay design or prefer our ready-to-use tests, we provide a versatile toolkit.

ddPCR Applications

  • Targeted/Reflex Mutational Screening, Therapy Response Tracking (ctDNA), Molecular Residual Disease (ctDNA), Molecular Relapse Monitoring (ctDNA)
  • Quantification of Low Abundant Genes
  • Absolute Molecular Quantification
  • ctDNA and cfDNA Detection
  • Mutation Detection (SNVs, INDELS, FUSIONS, etc.)
  • CNV (Gene Copy Number Variation)
  • VCN (Vector Copy Number)
  • Viral Titer
  • Gene Editing Analysis

Biodesix has years of experience with ddPCR based clinical diagnostics with the use of our GeneStrat® Test.

The GeneStrat® Test: This is a clinically validated and NYS CLEP approved ddPCR assay that evaluates 4 mutations, EGFR, ALK, KRAS, BRAF and ROS1 and RET upon request. This assay can be run with select markers or the full panel, whichever your testing needs require.
 
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Biodesix offers the GeneStrat Test as a Medicare covered commercial test for non-small cell lung cancer patients to help identify those that may benefit from adjuvant targeted therapy or clinical trial enrollment.

We have conducted 300,000+ variant-specific tests with ddPCR technology (the GeneStrat test).

  • Biodesix has a proven track record of regulatory approvals in NYS with 20+ successful submissions and approvals for commercial and clinical assays.
  • Fast turnaround within 3 business days of sample receipt
  • 0.02% Minor Variant Frequency (MVF)

MICROSATELLITE INSTABILITY (MSI)

  • The ddPCR Microsatellite Instability (MSI) Kit provides sensitive, reproducible, qualitative results for the detection of deletions and insertions in five mononucleotide microsatellite markers in plasma or tumor tissue samples.
  • Enables liquid biopsy monitoring
  • FFPE and plasma analysis from a single kit
  • Analyze up to 28 samples per instrument run
  • Improved workflow and cost efficiency over current methods
  • Automated data analysis with user-defined parameters
  • Excellent concordance with gold standard IHC and PCR-CE methods

Breast ESR1 Kit

Custom Assay Options

We can develop a custom ddPCR assay or validate an off the shelf ddPCR assay to measure your unique genetic mutations.

*Droplet Digital PCR and ddPCR and are trademarks of Bio-Rad Laboratories, Inc.

Next-generation Sequencing (NGS)

Next Generation Sequencing (NGS) is a high-throughput, massively parallel sequencing method renowned for generating substantial volumes of clinically pertinent data. Our extensive amplicon-based NGS testing solutions encompass both blood and tissue samples, featuring comprehensive cell-free nucleic acid assays, tumor mutation burden testing, and in-depth immune response analyses. Our comprehensive toolkit of NGS systems empowers precision medicine and diagnostic excellence.
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Our NGS Assay Solutions: 

Biodesix has years of experience with NGS testing based clinical diagnostics with the use of our GeneStrat NGS® Test.

The GeneStrat NGS® Test: This is a clinically validated/NYS CLEP approved 52 gene panel NGS assay.

  • Actionable driver and resistance mutations with our targeted panel, boasting a remarkable low detection limit of 0.1%.52 genes, 272 amplicons, spanning over 900 hotspots, indels, fusions, and copy number variations.
  • Benefit from a streamlined 3 business day workflow for rapid results.
  • Biodesix has a proven track record of regulatory approvals in NYS with 20+ successful submissions and approvals for commercial and clinical assays.

Biodesix offers the GeneStrat NGS Test as a Medicare covered commercial test for advanced stage non-small cell lung cancer patients to help identify those that may benefit from targeted therapy or clinical trial enrollment.

 

Cancer-Specific Assays: Targeted plasma-based assays for the detection of actionable driver and resistance mutations with a low limit of detection of 0.1%.
  • Lung cfTNA Assay
  • Lung cfDNA Assay
  • Breast cfDNA Assay v2
  • Breast cfDNA Assay
  • Colon cfDNA Assay
  • Myeloid Assay
  • Childhood Cancer Assay
  • Tumor Mutation Load Assay
  • Immune Response Assay
  • Immune Repertoire TCR Beta Assay