Precise Diagnosis for Precision Lung Cancer Drug: GE Healthcare’s Clarient Diagnostics Offering FDA approved PD-L1 companion diagnostic for Merck’s Keytruda®

Clarient to conduct companion diagnostic test to identify patients for  promising lung cancer drug

California, USA – 2 October 2015 –  Clarient Diagnostic Services, Inc. a division of GE Healthcare (NYSE:GE) announced it will be offering the FDA approved PD-L1 companion diagnostic which will help identify patients most likely to benefit from Merck’s newly-approved lung cancer drug, Keytruda.


With diagnostic analysis from Clarient, physicians will be able to understand the PD-L1 expression status for their patients with metastatic non-small cell lung cancer (NSCLC): Merck’s clinical trials suggest that the level of PD-L1 expression in a person’s tumor correlates with response to Keytruda.


To help identify eligible patients, Clarient will perform an FDA-approved assay that Merck developed with Dako, an Agilent Technologies Company. The assay (PD-L1 IHC 22C3 pharmDx) determines the expression status of the biomarker protein PD-L1 from a patient’s biopsy tissue sample, and can identify those patients that will likely respond most effectively to Keytruda.


“There are so many characterizations of cancers that we test for and classify at Clarient, that this type of precision diagnostics is what we do best,” said Dr. Kenneth Bloom, Chief Medical Officer of Clarient . “In a world where individualized medicine is the new norm, the information we glean from running the PD-L1 assay will be invaluable for physicians looking to include Keytruda as an option for their patients.”


“We believe that testing for the PD-L1 biomarker can provide important information that will help guide treatment decisions for patients with non-small cell lung cancer, “ said Frank Clyburn, president, Merck Oncology.  “We are pleased that GE Healthcare’s Clarient Diagnostics is making PD-L1 testing available to physicians and patients across the country given their  experience and capabilities in oncology diagnostics.”


Clarient’s pathologists have undergone in-depth training and are certified to perform the PD-L1 assay, ensuring a high level of accuracy and confidence in the results. Nationwide, physicians can submit patient biopsies to Clarient for testing to determine whether Keytruda is a feasible option for their patients.


About GE Healthcare

GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at


About Clarient Diagnostic Services, Inc.
Clarient Diagnostic Services, Inc.  is diagnostic laboratory licensed under CLIA and is a leading provider of comprehensive, cancer–diagnostic laboratory services. With its advanced technologies, Clarient is able to provide pathologists and oncologist with more accurate and detailed information to better characterize and assess cancer which can lead to more accurate diagnoses and more effective treatment.

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Erin Bryant

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