The test is a key component of icScore, an immune monitoring tool designed to help patients gain the most benefit from immunotherapy options in the treatment of cancer.

 Significantly, clinicians will now be able to use the blood test to help select the best treatment pathways and drug combinations for their patients.

The treatment of cancer has been revolutionized by the development of immunotherapies including PD-1 inhibitors and other checkpoint blockades. However, response rates are variable and better response rates are seen in patients with lower levels of Myeloid Derived Suppressor Cells (MDSC).

Therefore patients with elevated MDSC may benefit from supplemental drugs, and many combination therapies are currently in clinical development. Some of these combinations are thought to work by inhibiting MDSCs and thereby creating a permissive environment for activated T cells.

Dr. Jedd Wolchok, MD, PhD, Chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center (MSK); Associate Director of the Ludwig Center at MSK, and Director of the Parker Institute for Cancer Immunotherapy at MSK, is actively testing novel combinations of immunotherapy.

“In the future, oncologists will have a range of immunotherapy combinations available to them,” he said, “and this CLIA approved MDSC test will provide some guidance as physicians seek to optimize these novel treatment options.” Dr. Wolchok is Chair of the Scientific Advisory Board at Serametrix.

The assay, which utilizes flow cytometry and is carried out at a testing facility in Carlsbad, CA, was developed at the Ludwig Center at MSK and licensed by Serametrix in 2013. Already available as a service, the test is widely used by the pharmaceutical industry in clinical trials.

“Our mission is to standardize immune monitoring technologies developed in academic laboratories and to provide drug companies and physicians with access to these technologies,” said Henry Hepburne-Scott, Director of Business Development at Serametrix.

 “This CLIA approval will pave the way for the clinical application of icScore™, our single-sample battery of immune-based tests for cancer patients,” he added. Serametrix is part owned by the Ludwig Institute for Cancer Research in New York.

Also under development is a blood test for PD-L1-positive peripheral immune cells, which will be incorporated into CLIA testing as part of icScore™ later this year.

 As immuno-oncology drugs and their combinations continue to gain approval, Serametrix aims to meet demand for simple and effective monitoring of patient immuno-competency in the clinic.