New York State’s approval comes shortly after Sema4’s launch of Sema4 Signal, a new family of products and services providing data-driven precision oncology solutions, including a market-leading hereditary cancer panel composed of a comprehensive 112 gene panel
Sema4, a patient-centered health intelligence company, has announced that it has secured approval from the New York State Department of Health (NYS DOH) to conduct its Sema4 Signal Whole Exome/Transcriptome Sequencing (WES/WTS) and PanCancer somatic tests. Sema4 becomes the first company with a commercial laboratory to be approved by the NYS DOH for WES/WTS for solid and hematologic malignancies utilizing tumor-normal analysis. New York State’s approval comes shortly after Sema4’s launch of Sema4 Signal, a new family of products and services providing data-driven precision oncology solutions, including a market-leading hereditary cancer panel composed of a comprehensive 112 gene panel.
Until now, Sema4 has been offering WES/WTS outside of New York. New York is the only state in the U.S. requiring an independent regulatory review for laboratory-developed tests, which represents one of the most rigorous levels of validation.
Sema4’s WES/WTS test provides clinically-actionable information across the whole exome about a broad range of genomic variants, gene fusion and alternative splicing, and tumor mutational burden and microsatellite instability for solid and hematologic cancers. Sema4 Signal PanCancer, with a ~2,200 gene panel that is the largest in the market, delivers a targeted approach to DNA and RNA sequencing for solid and hematologic cancers. These tests inform on both somatic and germline findings, supported by genetic counseling and digital tools, and can be combined with the Sema4 Signal Hereditary Cancer test and Informatics tools, including clinical trial recruiting.
“New York State’s approval of our somatic profiling solutions is testament to the outstanding accuracy of the tests and reinforces that we have a market-leading solution for clinical care, research, and clinical trials,” said Eric Schadt, PhD, Founder and Chief Executive Officer of Sema4. “Following our announcement about Sema4 Signal, this development further highlights our commitment to using data science to improve cancer treatment. The data we generate from Sema4 Signal WES/WTS and PanCancer will be critical to delivering actionable insights that providers can use to administer care to their current patients while building better predictive models for future treatments.”
Sema4 is now starting to engage with the U.S. Food and Drug Administration (FDA) on securing federal government approval for the tests. As part of its mission to improve the diagnosis, treatment, and prevention of disease, Sema4 is also already collaborating with several clinician researchers and investigators, and pharmaceutical companies on initiatives related to its WES/WTS tests.
Source: Company Press Release