Serametrix announced that its test to predict cancer patients’ likely response to immunotherapy — by measuring their myeloid-derived suppressor cells (MDSC) — has received Clinical Laboratory Improvement Amendments (CLIA) approval for laboratory use in people.
The test, which determines the number of MDSC cells in the blood of cancer patients, is a key component of icScore, an immune monitoring tool that predicts and monitors responses to immunotherapies, helping patients gain the most from the currently available immunotherapy options for cancer treatment.
“Our mission is to standardize immune monitoring technologies developed in academic laboratories and to provide drug companies and physicians with access to these technologies,” Henry Hepburne-Scott, director of Business Development at Serametrix, said in a news release. “This CLIA approval will pave the way for the clinical application of icScore, our single-sample battery of immune-based tests for cancer patients.”
Although the development of immunotherapies, including immune checkpoint inhibitors like Opdivo, Keytruda, or Yervoy, has considerably advanced the treatment of cancer, many patients still exhibit poor responses. Identifying those patients will not respond to immunotherapies is critical, as it helps ensure they receive other treatment options in a timely manner.
MDSCs are immune cells that block the function of tumor-killing T-cells. Consistently, studies have reported that MDSC levels correlate with patients’ response to immunotherapies; those with lower levels of MDSCs are often the ones with better treatment outcomes.
This suggests that patients with high levels of MDSCs may benefit from supplemental drugs. A number of combination therapies are currently being tested for patients with high levels of MDSCs, and researchers believe that some of these combinations work by inhibiting MDSCs, which creates a permissive environment for activated T-cells.
“In the future, oncologists will have a range of immunotherapy combinations available to them, and this CLIA approved MDSC test will provide some guidance as physicians seek to optimize these novel treatment options,” said 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.
Wolchok, who is also chair of the Scientific Advisory Board at Serametrix, is currently testing new immunotherapy combinations.
Serametrix is also developing a new blood test for PD-L1-positive immune cells that it expects to incorporate into CLIA testing as part of icScore later this year.