Hematogenix, an industry leader in the field of integrated pathology services for drug development and immuno-oncology testing, announced the availability of the Ventana PD-L1 (SP142) and the PD-L1 (SP263) assays.
In May 2016, the Ventana PD-L1 (SP142) assay was approved by the US Food and Drug Administration (FDA) as a complementary diagnostic to provide PD-L1 status on patients with metastatic urothelial cancer (mUC) who are considering treatment with the FDA approved Roche immunotherapy Tecentriq (atezolizumab). The Ventana PD-L1 (SP263) is indicated as an aid in the assessment of PD-L1 expression in non-small cell lung cancer (NSCLC) and other tumor types.
"With the addition of these new PD-L1 assays SP142 and SP263, Hematogenix continues to lead the way in immuno-oncology testing," said Hytham Al-Masri, M.D., CEO and medical director of Hematogenix. "Our comprehensive PD-L1 offering has been expanded to include all four commercially available clones offered by Dako and Ventana. We feel by providing broad access to high quality PD-L1 testing, we will continue to help our physicians identify the most appropriate treatment options for their patients."
In April of this year, Hematogenix announced the availability of the FDA-approved PD-L1 companion diagnostic assays: PD-L1 IHC 22C3 pharmDx for Keytruda, Merck's anti-PD-1 therapy for metastatic non-small cell lung cancer, and PD-L1 IHC 28-8 pharmDx, a complementary diagnostic assay to support Bristol-Myers Squibb's Opdivo anti-PD-1 therapy for non-squamous non-small cell lung cancer and melanoma.