Skip to main content
Premium Trial:

Request an Annual Quote

GeneFirst Gets CE-IVD Mark for Coronavirus, Flu, RSV Combo Test Kit

NEW YORK — UK molecular diagnostics firm GeneFirst said on Tuesday that it has received CE-IVD marking for its COVID-19 Plus Detection Kit for the detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus.

The test kit, which provides results in under two hours, is PCR system-agnostic and is suitable for use with a range of instruments including Roche's LightCycler, and Thermo Fisher Scientific's Applied Biosystems 7500, according to a GeneFirst spokesperson.

The spokesperson added that the COVID-19 Plus Detection Kit is now available is Europe and Asia, and that GeneFirst expects to seek Emergency Use Authorization from the US Food and Drug Administration for the test in 2021.

GeneFirst is also leading a consortium called RAPID-COVID, funded with €2.8 million ($3.4 million) from Europe's Innovative Medicines Initiative, that is developing a diagnostic kit for the detection of SARS-CoV-2 plus 30 other common respiratory bacterial and viral pathogens, the spokesperson said. The test will be designed for point-of-care and laboratory use.

The Scan

Study Reveals New Details About Genetics of Major Cause of Female Infertility

Researchers in Nature Medicine conducted a whole-exome sequencing study of mote than a thousand patients with premature ovarian insufficiency.

Circulating Tumor DNA Shows Potential as Biomarker in Rare Childhood Cancer

A study in the Journal of Clinical Oncology has found that circulating tumor DNA levels in rhabdomyosarcoma may serve as a biomarker for prognosis.

Study Recommends Cancer Screening for Dogs Beginning Age Seven, Depending on Breed

PetDx researchers report in PLOS One that annual cancer screening for dogs should begin by age seven.

White-Tailed Deer Harbor SARS-CoV-2 Variants No Longer Infecting Humans, Study Finds

A new study in PNAS has found that white-tailed deer could act as a reservoir of SARS-CoV-2 variants no longer found among humans.