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FDA approves Dako’s new test for non-squamous carcinoma

The US Food and Drug Administration (FDA) has granted approval for Dako’s PD-L1 IHC 28-8 pharmDx immunohistochemistry test for its use as a complementary diagnostic for non-squamous non-small cell carcinoma

Quest Diagnostics will provide PD-L1 IHC 28-8 PharmDx test service to Bristol-Myers Squibb to support its FDA-approved Opdivo (nivolumab) to treat patients with previously treated metastatic non-small cell lung cancer (NSCLC).

The FDA approval allows Opdivo to be used for both previously treated squamous and non-squamous NSCLC.

Quest will provide PD-L1 IHC 28-8 pharmDx test service to physicians in all the 50 states of the US.

In the Phase III CheckMate 057 trial, the Dako test has been used to evaluate PD-L1 expression. It showed better overall survival in patients with previously-treated metastatic non-squamous NSCLC compared against chemotherapy.

According to Quest, biomarker testing is not required for Opdivo, but it will offer additional information to physicians.

Quest Diagnostics oncology general manager Dr Christopher Fikry said: "Lung cancer is the leading cause of cancer-related deaths, yet has traditionally been very difficult to combat with conventional therapies.

"The addition of the PD-L1 test to Quest’s oncology diagnostics arsenal will give physicians greater understanding of treatment expectations with Opdivo, a new treatment option, and helpful information to communicate to patients."

Quest provides diagnostics services primarily in oncology and genetics. Its services include screening, diagnosis, treatment selection and monitoring recurrence.

Recently, Quest Diagnostics has obtained FDA 510(k) approval for its Simplexa Flu A/B & RSV Direct Kit to be used for 46 additional influenza A and influenza B virus strains and 7 additional respiratory syncytial virus (RSV) strains.

The test can detect a total of 92 influenza and RSV virus strains, with the approval.