In%20Vitro%20Diagnostics

IVD Services

 

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)