Skip to main content
Premium Trial:

Request an Annual Quote

FDA Grants EUAs for Audere SARS-CoV-2 Sample Collection Kit, LGC Biosearch Tech COVID-19 Test

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for a SARS-CoV-2 testing sample collection kit developed by Audere and a PCR-based SARS-CoV-2 test from LGC Biosearch Technologies.

Audere's [email protected] Fusion collection kit is designed for the self-collection of anterior nasal swab specimens, either at home or in a healthcare setting, for molecular diagnostic testing at Audere-designated labs that are CLIA-certified to perform high-complexity tests.

In late 2021, Seattle-based Audere received EUA from the FDA for a similar COVID-19 testing specimen collection kit.

The Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test is designed to detect SARS-CoV-2 nucleic acid in anterior nasal swab specimens collected by a healthcare provider or self-collected under a healthcare provider's supervision. It is also authorized for use with samples collected using the [email protected] Fusion kit.

Use of the test is limited to labs CLIA-certified to perform high-complexity tests, according to the FDA.

About a year ago, LGC Biosearch Technologies, the genomics division of UK-based LGC, received EUA from the FDA for another PCR-based COVID-19 test.

The Scan

Cell Signaling Pathway Identified as Metastasis Suppressor

A new study in Nature homes in on the STING pathway as a suppressor of metastasis in a mouse model of lung cancer.

Using Bees to Gain Insights into Urban Microbiomes

As bees buzz around, they pick up debris that provides insight into the metagenome of their surroundings, researchers report in Environmental Microbiome.

Age, Genetic Risk Tied to Blood Lipid Changes in New Study

A study appearing in JAMA Network Open suggests strategies to address high lipid levels should focus on individuals with high genetic risk and at specific ages.

Study Examines Insights Gained by Adjunct Trio RNA Sequencing in Complex Pediatric Disease Cases

Researchers in AJHG explore the diagnostic utility of adding parent-child RNA-seq to genome sequencing in dozens of families with complex, undiagnosed genetic disease.