In%20Vitro%20Diagnostics

IVD Services

 

Transfer and Validate Companion Diagnostic Assays (CDx) on any platform

Personalized medicine is an evolving field in which treatments are tailored to the individual patient. The FDA requires a companion diagnostic test (CDx) if a new drug works on a specific genetic or biological target that is present in some, but not all, patients with a certain cancer. The CDx identifies which patients would benefit from the use of, or who could be harmed by use of a certain drug for treatment of their disease.

The CDx process works best when development of the test begins before the drug enters clinical trials. Early collaborations between pharmaceutical companies, test manufacturers, and laboratory services can result in faster access to promising new treatments for cancer patients. NeoGenomics' CDx Pharma Services works with 6 of the 10 manufacturers of FDA-cleared Companion Diagnostic Devices (In Vitro and Imaging Tools)* for convenient and fast CDx transfer and validations. NeoGenomics offers several FDA-Approved Assays and FDA-Cleared Assays for research and clinical use.

FDA-Approved Assays and FDA-Cleared Assays

NeoGenomics' Pharma Services offers a wide variety of assays utilizing FDA-Approved and FDA-Cleared assays and instruments on multiple modalities to help accelerate your drug development. All tests listed have been clinically validated in our laboratories and are available for research or clinical use. NeoGenomics has extensive experience with each of these assays. 

Clinically-validated FDA-cleared or FDA-approved assays:

Molecular

  • cobas® 4800 BRAF V600 (Zelboraf® or Vemurafenib)
  • cobas® EGFR Mutation Test v2 (Tagrisso or Osumertinib, Tarceva® or Erlotinib)
  • therascreen EGFR RGQ PCR (Gilotrif® or Afatinib, Iressa® or Gefitinib)  - offered as LDT
  • therascreen KRAS RGQ PCR (Erbitux® or Cetuximab, Vectibix® or Panitumumab)
  • THxID™ BRAF (Tafinlar® or Dabrafenib, Mekinist® or trametinib)

FISH

  • PathVysion HER-2 (Herceptin or Trastuzumab®)
  • UroVysion® Bladder Cancer Kit
  • Vysis CLL (Venclexta® or Venetoclax)
  • Vysis ALK (Xalkori® or Crizotinib)

IHC

  • ALK, D5F3 (Xalkori® or Crizotinib)
  • ER PharmDx
  • Her2/neu Pathway (4B5) (Herceptin or Trastuzumab®)
  • HercepTest (Herceptin or Trastuzumab®)
  • INFORM HER2 Dual ISH (Herceptin or Trastuzumab, Tykerb®)
  • PD-L1 22C3 PharmDx (Keytruda® or Pembrolizumab)
  • PD-L1 28-8 PharmDX (Opdivo® or Nivolumab)
  • PD-L1 SP142 (Tecentriq® or Atezolizumab)