Tests Can Identify More Cancer Patients Eligible for Merck’s KEYTRUDA® Therapy

CARLSBAD, Calif., July 6, 2017 — Genoptix, Inc., a leading oncology diagnostics laboratory and informatics company, today announced that it offers three diagnostic tests that support immunotherapy decisions for solid tumor cancers.

The tests include a companion diagnostic test for PD-L1 22C3 pharmDx, plus two complementary tests – one for microsatellite instability (MSI Analysis) and another for DNA mismatch repair (MMR). PD-L1 IHC 22C3 pharmDx is an immunohistochemical (IHC) test that detects the PD-L1 protein in non-small cell lung cancer (NSCLC) tissue. It was the first U.S. Food and Drug Administration (FDA) approved companion diagnostic to assess eligibility of NSCLC patients for Merck’s KEYTRUDA® (pembrolizumab) lung cancer drug .

According to the FDA, MSI-High and mismatch repair deficient (dMMR) tumors contain abnormalities that affect the proper repair of DNA inside the cell. Tumors with these biomarkers are most commonly found in colorectal, endometrial and gastrointestinal cancers, but also less frequently appear in cancers of the breast, prostate, bladder, thyroid gland and other places. Approximately five percent of patients with metastatic colorectal cancer have MSI-H or dMMR tumors. On May 23rd, 2017, the FDA announced the expanded indication of pembrolizumab for tumors with these two specific biomarkers.[1]

These tests represent an important component of Genoptix’s personalized medicine strategy to provide physicians with clinically actionable information to help them prescribe the right medicine for the right patient at the right time.

“We maintain our commitment as a leader in diagnostic testing for precision medicine, where genetic information from the tumor guides therapeutic choices,” said Joseph M. Limber, Chief Executive Officer and President of Genoptix.


1. U.S. Food and Drug Administration (FDA) Press Release, May 23, 2017, FDA Approves First Cancer Treatment for any Solid Tumor with a Specific Genetic Feature.

About Genoptix, Inc.

Genoptix is a leading clinical oncology laboratory specializing in hematology and solid tumors, and operates one of the largest hematopathology centers in the U.S. It provides personalized and comprehensive diagnostic services to hematologists, oncologists and pathologists, with a specialization in diagnosing cancers and disorders in bone marrow, blood, and lymph nodes, as well as in solid tumor workups using molecular testing. Through an integrated approach to case management, Genoptix delivers individualized, actionable results for each patient to help the referring physician make the best treatment decision. For more information, please visit http://genoptix.com.

Notes: Genoptix is a registered trademark of Genoptix, Inc. Any other names of actual companies, organizations, entities, products or services may be the trademarks of their respective owners.

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