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.
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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Experienced management team co-invests with leading private investors to acquire premier oncology diagnostics and informatics services company
CARLSBAD, Calif., March 7, 2017 — An experienced management team, led by Joseph M. Limber, in partnership with Ampersand Capital Partners and 1315 Capital, has completed the acquisition of Genoptix, Inc. from Novartis. The financial terms of the transaction are not being disclosed. Headquartered in Carlsbad, California, Genoptix is a recognized leader in its field, and is one of the largest hematopathology centers in the United States. Since 1999, Genoptix has worked with thousands of oncologists and pathologists across the country, providing a comprehensive suite of testing solutions in hematology and solid tumor molecular profiling. More recently, Genoptix pioneered the development and commercialization of a number of proprietary technologies, such as Next Generation Sequencing (NGS) panels based on clinically validated markers.
Joseph M. Limber, who previously served as CEO of Prometheus Laboratories, will lead the new Genoptix as Chief Executive Officer. He will be joined by Mark Spring as Chief Financial Officer and Juan Estruch as Head of Corporate Development, both of whom served with Limber on the executive team at Prometheus Laboratories.
“We are extremely excited to continue to build on the Genoptix brand and renowned history in the field of oncology molecular diagnostics,” said Limber. “Together with the committed employees of Genoptix, we look forward to continuing to innovate and expand our outstanding suite of services and solutions that provide powerful informational tools for clinicians to ultimately improve patient care.”
About Ampersand Capital Partners
Ampersand is a private equity firm with a focus on growth equity investments in the healthcare sector. Over the past two decades, Ampersand has managed more than $1 billion in private equity partnerships. Ampersand leverages its unique blend of private equity and operating experience to build value and drive superior long-term performance alongside its portfolio company management teams. Additional information about Ampersand is available at www.ampersandcapital.com.
About 1315 Capital
1315 Capital provides expansion and growth capital to commercial-stage specialty pharmaceutical, medical technology, and healthcare services companies. 1315 Capital leverages experienced investors and proven operating teams to work alongside portfolio company management to rapidly grow platform companies into high value businesses that positively impact patients, physicians, and the broader healthcare system. For more information, visit www.1315capital.com.
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Medical Director: Derek Lyle, MD
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