NEW YORK ─ Sema4 said on Wednesday that it has secured approval from the New York State Department of Health to conduct its Sema4 Signal Whole Exome/Transcriptome Sequencing (WES/WTS) and PanCancer somatic tests.
The firm said it believes it is the first company with a commercial laboratory to be approved by the NYS DOH for WES/WTS for solid and hematologic malignancies using tumor-normal analysis.
The New York State approval comes shortly after the company launched Sema4 Signal, a new family of products and services providing data-driven precision oncology solutions, including a 112-gene hereditary cancer panel.
"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," Eric Schadt, the firm's founder and CEO, said in a statement.
Stamford, Connecticut-based Sema4 has been offering WES/WTS outside of New York state, which is the only state in the US that requires an independent regulatory review for laboratory-developed tests, the firm noted.
Its Sema4 Signal WES/WTS test provides clinically actionable information across the whole exome about a broad range of genomic variants, gene fusions and alternative splicing, tumor mutational burden, and microsatellite instability for solid and hematologic cancers. Sema4 Signal PanCancer, a panel of approximately 2,200 genes, delivers a targeted approach to DNA and RNA sequencing for solid and hematologic cancers.
The tests provide both somatic and germline findings supported by genetic counseling and digital tools, and they can be combined with the Sema4 Signal Hereditary Cancer test and informatics tools, including those used for clinical trial recruiting.
The company said it is beginning to engage with the US Food and Drug Administration to secure the agency's approval for its tests. Sema4 said it is also collaborating with clinician-researchers, investigators, and pharmaceutical companies on initiatives related to its WES/WTS tests.