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The other two finalists were PixCell, for its lab-on-cartridge and AI technology, and Singlera Genomics, for its ColonES assay. Singlera’s test uses next-generation sequencing-based targeted methylation haplotyping of bisulfite-treated cell-free DNA for early colorectal cancer screening.

FDA approves Rozlytrek, targets ROS1 and NTRK

The Food and Drug Administration approved Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer. The FDA also granted accelerated approval to Rozlytrek for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

These approvals are based on results from the integrated analysis of the pivotal phase two STARTRK-2, phase one STARTRK-1, and phase one ALKA-372-001 trials, and data from the phase one/two STARTRK-NG study. In the integrated analysis, Rozlytrek was studied in several solid tumor types, including breast, cholangiocarcinoma, colorectal, gynecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma, and thyroid cancers. In ROS1-positive, metastatic NSCLC, Rozlytrek shrank tumors in 78 percent of people with the disease (N = 51) and the duration of response ranged from 1.8 to 36.8+ months (N = 40 of 51). Rozlytrek also shrank tumors in more than half of people with NTRK gene fusion-positive, locally advanced or metastatic solid tumors (N = 54), and objective responses were observed across 10 tumor types. Objective responses to Rozlytrek were seen in people with central nervous system metastases at baseline.

“Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and, importantly, has also shown responses in these rare cancer types that have spread to the brain,” Sandra Horning, MD, Genentech chief medical officer and head of global product development, said in an Aug. 15 statement.

Foundation Medicine will submit FoundationOne CDx to the FDA for approval as a companion diagnostic for Rozlytrek. An FDA-approved companion diagnostic for Rozlytrek is not available at this time.

Exact Sciences and Genomic Health to combine

Exact Sciences and Genomic Health have entered into a definitive agreement under which Exact Sciences will combine with Genomic Health for $72 per share in a cash and stock transaction valued at $2.8 billion. The transaction is expected to be completed by the end of this year.

The combined company will offer Cologuard and Oncotype DX, “providing a robust platform for continued growth,” Exact Sciences said in a July 29 statement.

“Together, with our collective resources and broader platform, we will be able to provide our existing tests to more people, while also accelerating the development and launch of future cancer diagnostic tests,” Kevin Conroy, chairman and CEO of Exact Sciences, said in the statement.

Sysmex releases PS-10 Sample Preparation System

Sysmex America has made available its PS-10 Sample Preparation System for use in flow cytometry. Sysmex says the highly automated and flexible PS-10 provides clinical labs a new level of workflow ​efficiency and confidence in results.

The PS-10 automates sample preparation and eliminates variability among operators. It also offers programmable sample preparation for antibody cocktailing and reduces the amount of manual transfer of samples performed by laboratory staff.