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The Korean molecular diagnostics firm, a spinoff from genomic services provider Macrogen, also announced plans for an IPO early next year.
The assay combines Twist's Human Comprehensive Exome with customized content for rare and inherited diseases from Australia-based VCGS.
Under the non-exclusive deal, Natera will use matched tumor and normal exome sequencing data from Personalis to validate the design of its Signatera ctDNA assays.
The Helix Laboratory Platform is the first whole-exome sequencing platform to receive do novo authorization by the agency and paves the way for others.
NSIGHT2 researchers surveyed the parents and doctors of sick babies to see how useful they found positive and negative findings from genome sequencing tests.
During a session at the ASHG 2020 virtual meeting, representatives from both organizations laid out the reasons for their contrasting guidelines.
The firm said the New York State approval for the two tests comes soon after it launched Sema4 Signal, a family of precision oncology products and services.
ArcherDx will develop sequencing-based circulating tumor DNA assays for use in AstraZeneca's recently launched Phase III MERMAID-1 trial of durvalumab (Imfinzi).
Blueprint Genetics, recently acquired by Quest Diagnostics in January, will base the 600-gene panel on its whole-exome sequencing capability.
Nearly 3,500 patients were referred to the Roberts Individualized Medical Genetics Center for exome sequencing or other testing during the clinical program's first four years.