New cancer testing product from Ann Arbor company

ANN ARBOR—Strata Oncology, a developer of cancer testing technology for hospitals and the pharmaceutical industry, announced the launch of version 3.0 of StrataNGS, its pan-cancer assay for solid tumors.

The updated 500-gene assay uses DNA and RNA from tumor samples to detect all clinically actionable biomarkers—including microsatellite instability (MSI), tumor mutational burden (TMB), and PD-L1—recommended by leading guidelines, in a single test. Test results are provided in a streamlined report that facilitates rapid, confident interpretation and identification of potential treatment options and clinical trials.

“Our expanded assay, providing deep cancer insights and leading performance, represents our commitment to bring a best-in-class diagnostic to oncologists and pathologists across the Strata network of health systems,” said Scott Tomlins, Strata’s chief medical officer. “In addition to providing physicians with all relevant genomic information needed to make an informed treatment decision, the test will help inform new trial design and accelerate drug development.”

StrataNGS is provided at no cost to advanced cancer patients enrolled in the Strata Trial at the company’s partner health systems. Results are returned in less than 10 business days using industry-low sample input requirements. The test employs RNA and DNA sequencing to simultaneously detect important information about the tumors such as mutations, small frame-preserving insertions/deletions (indels), amplifications, deep deletions, de novo deleterious mutations, gene fusion events, MSI, TMB, and PD-L1.

In addition, the updated assay includes analytical validation of 36 gene expression markers that represent emerging immuno-oncology and antibody-drug conjugate targets. Although these biomarkers are not yet reported clinically, the data is available to Strata Oncology and investigators at partner cancer centers for correlative analyses and new trial design.

Strata Oncology was founded in 2016 by leaders in the fields of cancer genomics, molecular pathology, and clinical oncology from Harvard Medical School and the University of Michigan. The company is funded by Ann Arbor-based Arboretum Ventures, Milwaukee-based Baird Capital, San Francisco-based Deerfield Partners, Whitehouse Station, N.J.-based Merck Health Innovation Fund, and New York City-based Pfizer Ventures.

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