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FDA Issues Emergency Use Authorizations for QDx Pathology, Biocan Diagnostics Coronavirus Tests

NEW YORK — The US Food and Drug Administration on Tuesday granted separate Emergency Use Authorizations for SARS-CoV-2 tests developed by QDx Pathology Services and Biocan Diagnostics.

The QDx SARS-CoV-2 Assay is a RT-PCR-based assay designed to detect the N gene of the virus in nasal swab specimens self-collected using the Cranford, New Jersey-based medical lab's Qdetect home collection kit or other authorized home collection kits. It is performed using ChromaCode's HDPCR SARS-CoV-2 assay, which received EUA from the FDA in June, and may only be performed in QDx's CLIA-certified lab. 

Biocan's Tell Me Fast Novel Coronavirus IgG/IgM Antibody Test is an immunochromatography-based lateral flow assay designed to detect immunoglobulin G and M antibodies against SARS-CoV-2 in serum, plasma, and venous whole blood samples. Results are provided within 15 minutes, according to the British Columbia, Canada-based company.

The test may be used by any lab CLIA-certified to perform moderate- or high-complexity tests.

The Scan

Interfering With Invasive Mussels

The Chicago Tribune reports that researchers are studying whether RNA interference- or CRISPR-based approaches can combat invasive freshwater mussels.

Participation Analysis

A new study finds that women tend to participate less at scientific meetings but that some changes can lead to increased involvement, the Guardian reports.

Right Whales' Decline

A research study plans to use genetic analysis to gain insight into population decline among North American right whales, according to CBC.

Science Papers Tie Rare Mutations to Short Stature, Immunodeficiency; Present Single-Cell Transcriptomics Map

In Science this week: pair of mutations in one gene uncovered in brothers with short stature and immunodeficiency, and more.