NEW YORK (GenomeWeb) – T2 Biosystems today said that it has filed a 510(k) premarket submission with the US Food and Drug Administration for its T2Dx system and T2Candida assay.

The Lexington, Mass.-based firm said that it has submitted clinical trial data to the agency providing evidence that the instrument and assay can identify specific life-threatening, sepsis-causing pathogens directly from an unpurified blood sample in as fast as three hours. Current culture-based diagnostic methods typically take two to five days to provide an answer, T2 noted.

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In Science this week: caution urged in use of gene drives, and more.

NIH's Sally Rockey examines the tapped and untapped potential of the NIH peer reviewer pool.

PLOS Biology has asked researchers how they envision the future of genetics and genomics.

Representative Lamar Smith brings back a provision to require the National Science Foundation to certify that each study it funds is "in the national interest."

Sep
17
Sponsored by
Omicia

This online seminar will provide examples of how commercial and hospital-affiliated clinical labs are successfully developing and deploying high-throughput next-generation sequencing-based testing services for genetic diseases. 

Oct
15
Sponsored by
Parabase

This webinar will discuss the benefits of a rapid targeted next-generation sequencing (TNGS) panel, using dried blood spots, for second-tier newborn metabolic and hearing loss screening and its immediate utility for high-risk diagnostic testing in the neonatal intensive care unit.