Skip to main content
Premium Trial:

Request an Annual Quote

DiaCarta Nabs FDA Emergency Use Authorization for Monkeypox Test

NEW YORK – The US Food and Drug Administration said on Tuesday it has granted Emergency Use Authorization for DiaCarta's monkeypox PCR test.

Pleasanton, California-based DiaCarta's laboratory-use QuantiVirus MPXV Test Kit is intended to qualitatively detect monkeypox virus DNA in human lesion swab samples from people with suspected monkeypox infections, as determined by a healthcare provider. The firm said Thursday that its real-time multiplex PCR test is designed for use on qPCR instruments including Thermo Fisher Scientific's QuantStudio5, its 7500 Fast Dx, Bio-Rad Laboratories' CFX384, and Roche LightCycler 480 II Systems, the firm said.

DiaCarta said the QuantiVirus MPXV test targets two regions of the MPXV genome, as recommended by the US Centers for Disease Control and Prevention, to ensure the test remains effective if the virus mutates in one of the target regions. The FDA said in its letter that while positive test results indicate the virus DNA is present, correlation with a patient's clinical history and other diagnostic information is needed to determine their infection status.

The Scan

Self-Reported Hearing Loss in Older Adults Begins Very Early in Life, Study Says

A JAMA Otolaryngology — Head & Neck Surgery study says polygenic risk scores associated with hearing loss in older adults is also associated with hearing decline in younger groups.

Genome-Wide Analysis Sheds Light on Genetics of ADHD

A genome-wide association study meta-analysis of attention-deficit hyperactivity disorder appearing in Nature Genetics links 76 genes to risk of having the disorder.

MicroRNA Cotargeting Linked to Lupus

A mouse-based study appearing in BMC Biology implicates two microRNAs with overlapping target sites in lupus.

Enzyme Involved in Lipid Metabolism Linked to Mutational Signatures

In Nature Genetics, a Wellcome Sanger Institute-led team found that APOBEC1 may contribute to the development of the SBS2 and SBS13 mutational signatures in the small intestine.