Clinical OMICS

MAY-JUN 2018

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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www.clinicalomics.com May/June 2018 Clinical OMICs 9 CellMax Life, IncellDx to Develop CTC-based Liquid Biopsy Diagnostics Liquid biopsy diagnostic developer CellMax Life and single-cell diagnostics company IncellDx announced they will join efforts to develop and market circu- lating tumor cell (CTC) blood tests across multiple solid tumors and indications to provide personal- ized therapy selection and monitoring. CellMax Life's CTC blood test, based on its CMxTM platform, which captures CTCs with a proprietary microfluidic chip with biomimetic coat- ing and custom antibodies, will be combined with IncellDx's proprietary microfluidic reagents BioINK to analyze both protein and/or mRNA expression. BioINK enables highly sensitive and specific quan- tification of protein or mRNA expression at a sin- gle-cell resolution. The first product created under this collaboration is a proprietary blood test to quantify the expression of PD-L1—a key protein involved in suppressing the immune system—used for immunotherapy selection and monitoring. There are close to 3,500 active biomarker-driven cancer clinical trials currently recruiting patients, and many of these trials rely solely on tissue-based biomarkers. Unfortu- nately, tissue tests may be inadequate, putting clinical trials at risk. This is true of tissue testing for PD-L1 expression for immunotherapy selection. According to David Gandara, M.D., oncologist and direc- tor of the Thoracic Oncology Program at University of Cali- fornia, Davis, "PD-L1 can be unevenly distributed in tissue, leading to a false negative, and denying patients the oppor- tunity to receive immunotherapy. A PD-L1 blood test can overcome these issues and would be an attractive alterna- tive to tissue testing." Several published studies have demonstrated the utility of CTC PD-L1 tests for immunotherapy monitoring, includ- ing a study showing that patients without PD-L1+ CTCs after six months of treatment showed a clinical benefit from nivolumab—an immunotherapy used to treat cancer—while patients with PD-L1+ CTCs experienced disease progression. Performance data of the PD-L1 test in non-small cell lung cancer (NSCLC) were presented recently at the American Academy of Cancer Research (AACR) annual meeting. The test was able to capture CTCs for PD-L1 testing in blood in about 90% of patients across all stages of cancer. About 50% of the patients tested for CTCs were PD-L1 positive. This is consistent with previously reported PD-L1 positivity rates in clinical studies. Bruce Patterson, M.D., CEO and founder of IncellDx said, "Cancer is driven at different levels: DNA, RNA, and pro- tein. With CTC-based liquid biopsies, we can analyze all of these analytes simultaneously in intact cells, combining antibodies, quantitative RNA in situ hybridization, and DNA cell cycle. This is not possible with most current liquid biopsies that analyze only DNA from lysed cells. CellMax Life's CTC blood test has unprecedented sensitivity in iso- lating rare CTCs, which can be readily analyzed by the Bio- INK platform at the single-cell level. Our joint efforts will lead to reliable diagnostic solutions throughout the patient treatment continuum." The tests will be processed at CellMax Life's CLIA-CAP accredited lab in Sunnyvale, CA and will be jointly mar- keted in the United States by the companies' sales forces. JUAN GARTNER / Getty Images

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