Skip to main content
Premium Trial:

Request an Annual Quote

FDA Grants Emergency Use Authorization for Nanobiosym PCR COVID-19 Test

NEW YORK — The US Food and Drug Administration this week granted Emergency Use Authorization for Nanobiosym Precision Testing Services' Nano Test for COVID-19.

The RT-PCR-based test is designed for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens self-collected at home using Nanobiosym's Nano-Saliva Collection Kit. It is based on the FDA-authorized PerkinElmer New Coronavirus Nucleic Acid Detection Kit, which targets the N and ORF1ab gene of SARS-CoV-2.

Use of the Nano Test for COVID-19 is limited to Cambridge, Massachusetts-based Nanobiosym, according to the FDA.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.