Skip to main content
Premium Trial:

Request an Annual Quote

FDA Grants Emergency Use Authorization for Northeastern University SARS-CoV-2 Test

NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for an RT-PCR-based SARS-CoV-2 test developed by Northeastern University's Life Sciences Testing Center.

The Life Sciences Testing Center COVID-19 Test is designed to detect the SARS-CoV-2 N, ORF1ab, and S genes in anterior nasal specimens self-collected using the Life Sciences Testing Center COVID-19 Home Collection Kit.

The test uses the authorized Thermo Fisher Scientific TaqPath COVID-19 Combo Kit and runs on Thermo Fisher's Applied Biosystems 7500 Fast Dx system. The test may only be used by the Life Sciences Testing Center, according to the FDA.

The Scan

UK Pilot Study Suggests Digital Pathway May Expand BRCA Testing in Breast Cancer

A randomized pilot study in the Journal of Medical Genetics points to similar outcomes for breast cancer patients receiving germline BRCA testing through fully digital or partially digital testing pathways.

Survey Sees Genetic Literacy on the Rise, Though Further Education Needed

Survey participants appear to have higher genetic familiarity, knowledge, and skills compared to 2013, though 'room for improvement' remains, an AJHG paper finds.

Study Reveals Molecular, Clinical Features in Colorectal Cancer Cases Involving Multiple Primary Tumors

Researchers compare mismatch repair, microsatellite instability, and tumor mutation burden patterns in synchronous multiple- or single primary colorectal cancers.

FarGen Phase One Sequences Exomes of Nearly 500 From Faroe Islands

The analysis in the European Journal of Human Genetics finds few rare variants and limited geographic structure among Faroese individuals.