This new class of diagnostic testing — liquid biopsy — is enabling our understanding of the genomic landscape and functionality of cancer as well as developing enhanced precision medicine approaches to patient treatment and management.

PlasmaDx: A Class Apart

Because tumors release their DNA and tumor cells (primary or metastatic) into the bloodstream, sensitive techniques have been developed to detect these distinct signatures (biomarkers), yielding actionable diagnostic information. The two types of biomarkers are most often interrogated through liquid biopsy are:

  • Circulating tumor DNA (ctDNA), a component of cell-free DNA (cfDNA)
  • Circulating tumor cells (CTCs)

Of the two types, ctDNA is more accessible in plasma. Levels of ctDNA have been found to correlate with tumor burden, treatment response, relapse or surgery and to indicate disease proliferation. With the development of sensitive techniques enabling detection of rare mutations and genetic alterations (SNVs, CNVs, fusions, indels), liquid biopsy makes it possible to understand the heterogeneous landscape of the tumor and identify therapeutic targets for treatment planning purposes.

Methodology: ctDNA is extracted from peripheral blood plasma and analyzed on a panel of genes selected and targeted to the clinical scenario.

 

PlasmaDx

PlasmaDx is a collection of circulating tumor (ct)DNA tests validated for use in our CAP/CLIA certified laboratory covering a wide variety of clinical oncology scenarios including support for biopharmaceutical clinical trials and biomarker testing for individual cancer patients.

TEST FEATURES

  • 14-day turn-around-time (TAT)
  • High (> 90 percent sensitivity) at low ≥ 0.5 percent allele frequencies
  • Broad coverage across tumor types

CLINICAL FEATURES

Each assay provides information about the status of clinically-actionable genomic alterations (SNVs, indels, fusions, CNAs) including those targeted by FDA-approved therapeutics. A matched tissue/plasma testing option is also available.

PlasmaDx Liquid Biopsy Options

PlasmaDx 17

  • Analyzes hotspot areas of 17 cancer-related genes
  • Optimized for non-small cell lung cancer (NSCLC) and colorectal cancer (CRC)
  • Applicable for pan-cancer applications
  • Best choice for on-label therapeutic decision-making or plasma monitoring of tumors with known EGFR, KRAS, BRAF genomic alterations

PlasmaDx 197

  • Analyzes hotspot and whole exon targets of 197 cancer-related genes
  • Includes guideline driven and emerging tumor biomarkers for therapeutic decision making
  • Applicable for longitudinal monitoring of tumor burden and identification of targetable genomic alterations
  • Best choice for detecting a patient’s cancer personalized profile by deep sequencing (CAPP-Seq)

PlasmaDx 77

  • Analyzes hotspot areas of 77 cancer-related genes
  • Optimized for NSCLC and CRC with expanded gene list and hotspot coverage
  • Applicable for plasma monitoring of tumor burden and identification of targetable genomic alterations
  • Best choice for higher coverage for pan-cancer applications and biomarker discovery

PlasmaDx 500

  • Analyzes multiple variant types including tumor mutational burden (TMB) and microsatellite instability (MSI)
  • Applicable for small high grade tumors at the time of diagnosis and pre/post-surgery tumor burden monitoring
  • Best choice for biomarker identification in tissue followed by monitoring in plasma ctDNA

What is a Liquid Biopsy?

A liquid biopsy is any type of clinical specimen other than solid tissue including blood, urine, cerebrospinal fluid (CSF) or other body fluids that can be evaluated for diagnostic purposes, particularly cancer genomics. Most liquid biopsies refer to non-invasive genomic blood tests that can provide valuable information and reduce the need for invasive tumor tissue biopsy.

Limitations of Tissue Biopsy

DNA obtained from tissue biopsies represents a snapshot in time of an ever-changing tumor genome. However, due to inherent risks to the patient for obtaining serial invasive tissue biopsies, molecular pathologists have relied on archival diagnostic tumor tissue to search for chemotherapeutic drug targets in the patient’s tumor genome. Until recently there were no alternative methods for viewing the tumor genome, but now with advances in biotechnology, we have the tools to capture and analyze tumor DNA from a patient’s blood and other body tissues in the form of a liquid biopsy.

Contact us today to learn more about our extensive array of clinical, esoteric, and consulting laboratory services for biopharmaceutical and clinical diagnostics laboratories. Or visit our companion diagnostics company, ResearchDx, to learn how our IVD and biopharma development services can simplify delivery of your FDA-approved companion diagnostics on time.