Skip to main content
Premium Trial:

Request an Annual Quote

Atila Biosystems Gets FDA Emergency Use Authorization for SARS-CoV-2 Test

NEW YORK – The US Food and Drug Administration on Friday granted Emergency Use Authorization for Atila Biosystems' SARS-CoV-2 test.

The iAMP COVID-19 Detection Kit, a qualitative real-time RT-PCR test, detects SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swabs. The kit includes the company's primer mix, buffer mix, positive and negative control templates, and the sample collection device, which has fiber swabs, collection tubes, and buffer mix.

According to the Mountain View, California-based company, the test is unique because it can detect SARS-CoV-2 RNA directly from samples without a prior RNA extraction process. The test takes less than two hours for results, the company added. 

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

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.