CellMax Life and IncellDx Partner to Develop Blood Tests to De-Risk Clinical Trials Relying on Tissue-Based Biomarkers

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Tests to be run on CellMax Life’s platform for circulating tumor cells—the only liquid biopsy with proven sensitivity and cost-effectiveness for therapy selection and monitoring

CellMax Life, a leading cancer diagnostics company enabling early cancer detection with affordable non-invasive blood tests, has signed an agreement with IncellDx, Inc., a single-cell molecular diagnostics company, to join efforts in developing and marketing circulating tumor cell (CTC) blood tests across multiple solid tumors and indications, including personalized therapy selection and monitoring.

CellMax Life’s CTC blood test, based on its CMxTM platform, capturing CTCs with a proprietary microfluidic chip with biomimetic coating 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 quantification of protein or mRNA expression at a single-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. Unfortunately, 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 Dr. David Gandara, oncologist and director of the Thoracic Oncology Program at University of California, Davis, “PD-L1 can be unevenly distributed in tissue, leading to a false negative, and denying patients the opportunity to receive immunotherapy. Up to 20 percent of PD-L1 negative patients in tissue tests have been known to respond to immunotherapy. Looking into the future, blood-based testing provides a means for repeat testing and timely monitoring, which would not be possible otherwise. A PD-L1 blood test can overcome these issues and would be an attractive alternative to tissue testing.”

Several published studies have demonstrated the utility of CTC PD-L1 tests for immunotherapy monitoring, including a study showing that patients without PD-L1+ CTCs after 6 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) will be presented in Chicago at the American Academy of Cancer Research (AACR) Annual Meeting, taking place on April 14 through 18. The test was able to capture CTCs for PD-L1 testing in blood in about 90 percent of patients across all stages of cancer. About 50 percent of the patients tested for CTCs were PD-L1 positive. This is consistent with previously reported PD-L1 positivity rates in clinical studies (Abstract 3653/13).

Dr. Bruce Patterson, CEO and founder of IncellDx said, “Cancer is driven at different levels: DNA, RNA and protein. 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 isolating rare CTCs, which can be readily analyzed by the BioINK 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, California and will be jointly marketed in the United States by the company’s sales force.

“We are excited to partner with IncellDx, whose highly accurate reagent platform will bring tremendous added value to our tests,” said Atul Sharan, CEO of CellMax Life. “Together with IncellDx, we will be a valuable partner for pharmaceutical clinical trials looking for multi-analyte blood tests for therapy selection and monitoring. The PD-L1 test is just the beginning of what this joint venture will accomplish.”

To learn more about the partnership, attendees of AACR’s Annual Meeting can visit the joint CellMax Life and IncellDx booth #3506 in Chicago on April 14 through 18.

About CellMax Life
CellMax Life is a leading cancer diagnostics company whose mission is to transform how cancer is diagnosed and managed with globally affordable non-invasive tests for early cancer detection and management. CellMax Life’s unique expertise in circulating tumor cells (CTC) and next generation sequencing (NGS) of DNA, as well as circulating tumor DNA (ctDNA) has enabled it to offer highly effective precision medicine solutions for healthy people, as well as patients diagnosed with cancer.

CellMax Life’s tests include CellMax-DNA Hereditary Cancer Risk Test, CellMax-CRC Colorectal Cancer Screening Test, CellMax-Prostate Cancer Test, CellMax-LBx Liquid Biopsy for immunotherapy and targeted therapy selection and CellMax-PanCa Monitoring Test. All clinical testing is performed at CLIA and CAP accredited laboratories in Sunnyvale, California and Taipei, Taiwan.

For additional information, please visit http://www.cellmaxlife.com.

About IncellDx
IncellDx, Inc., located at Menlo Park, California, USA is a single cell diagnostic company committed to advancing Precision Medicine by offering transformative diagnostic and prognostic clinical patient information based on an innovative technology platform that enables quantitative, simultaneous cell classification and single cell protein analysis, multiplex RNA in situ hybridization, and DNA cell cycle analysis on flow cytometers, microfluidic devices, and microscope slides.

Antenna Group
Michael Simmons (Media Contact)

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