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FDA clearance

May 13, 2020

Adaptive Eyes NGS-Based Test for T Cell Response in COVID-19

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The diagnostics firm is conducting a 1,000-person study to find T cell profiles associated with the immune response to COVID-19 and recovery from the disease.

Apr 27, 2020

FDA Clears Cancer Genomic Profiling Kit From Personal Genome Diagnostics

The firm said the FDA clearance was supported by data across several lab sites and all variant classes in clinical samples from 35 tumor types.

Apr 13, 2020

Rutgers Gets FDA EUA for Modified Thermo Fisher Coronavirus Assay for Use With Saliva Samples

Originally developed by Thermo Fisher Scientific, the test is modified for use on additional specimen types, including saliva, as well as with alternative nucleic acid extraction and amplification systems.

Apr 01, 2020

FDA Proposes Reclassification of HCV RNA, Antibody Tests

If the proposal is finalized, the tests will go through a less burdensome process to obtain marketing clearances.

Mar 31, 2020

Qiagen Receives FDA Emergency Use Authorization for SARS-CoV-2 Respiratory Panel

The panel can detect and differentiate SARS-CoV-2 and 20 other pathogens known to cause serious respiratory disease from nasopharyngeal swabs in symptomatic patients.

Mar 13, 2020

FDA Issues Emergency Use Authorization for Roche SARS-CoV-2 Test

The test is the third to receive EUA, following tests from the CDC and New York state, and it runs on Roche's Cobas 6800 and 8800 systems.

Feb 23, 2020

Asuragen Fragile X Diagnostic Test Gets FDA Authorization

The firm's AmplideX Fragile X Dx and Carrier Screen Kit is intended to help diagnose fragile X syndrome and assess parental risk of having a child with the syndrome.

Jan 22, 2020

OraSure's DNA Genotek Gets FDA Clearance for Sample Collection Kits

The devices are used for collection and stabilization of saliva samples for genetic testing, such as diagnostic testing or direct-to-consumer use.

Dec 17, 2019

FDA Clears DiaSorin Molecular VZV Test

The firm said that with this clearance it now provides a comprehensive menu of VZV and HSV tests from swab and cerebrospinal fluid specimens.

Dec 04, 2019

FDA Approves Foundation Medicine CDx for Novartis Breast Cancer Drug Piqray

The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.

Breaking News

The Scan

Preprints During Lockdown

New analyses indicate female researchers are publishing less during the coronavirus pandemic than male researchers, according to Nature News.

ApoE and COVID-19

A study suggests people with the ApoE e4 genotype may be more likely to have severe COVID-19 than those with other genotypes, the Guardian says.

Search for Genetic Clues to COVID-19 Severity

Direct-to-consumer genetic testing companies are searching for a genetic reason for why some people, but not others, become gravely ill with COVID-19, the Detroit Free Press reports.

PNAS Papers on Retinal Development, Adoptive T Cell Transfer, Blood Cell Differentiation

In PNAS this week: forward genetics-base analysis of retinal development, interactions of T cell receptors with neoantigens in colorectal cancer, and more.

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