Euformatics said Friday that it has received a CE-IVD mark for its OmnomicsNGS variant interpretation and reporting software. The technology previously had CE marking as a Class I medical device under earlier European Union rules.

The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for an at-home sample collection kit for SARS-CoV-2 molecular testing developed by nonprofit digital health firm Audere.

Thermo Fisher Scientific held the unveiling ceremony of the first domestic gas chromatography-mass spectrometry in Suzhou factory. Runda announced that the new generation of clinical mass spectrometer - ARP-6465md triple quadrupole mass spectrometer system has been released.

To improve outcomes for patients with vascular disease, patients need accurate diagnoses and coordinated care early in their “patient journey,” Abbott concluded in its latest Beyond Intervention report.

Danaher said late Wednesday that it has priced its offering of $1 billion principal amount of senior notes.

in November, several IVD companies cooperated with colleges and universities

Ever since the first barcode appeared on a pack of chewing gum in 1974, the now-ubiquitous system has enabled manufacturers, retailers and consumers to quickly and effectively identify, characterize, locate and track products and materials.

Freenome said on Wednesday that it has partnered with German medical technology firm Siemens Healthineers on the identification of blood-based biomarkers for breast cancer detection.

On 1 December 2021, WHO is calling on global leaders and citizens to rally to confront the inequalities that drive AIDS and to reach people who are currently not receiving essential HIV services.

Abbott and BD contend that they continue to monitor emerging COVID-19 variants of concern, such as omicron, and none have impacted the ability of their respective diagnostics to detect the virus.

French diagnostics firm Novacyt said last week that its Genesig COVID-19 Real-Time PCR assay has been approved in the UK under newly implemented regulations on SARS-CoV-2 tests.

IMPACT trial data shows clear benefit in using Roche's CINtec PLUS Cytology test for women who are at higher risk of developing cervical cancer

Currently available polymerase chain reaction (PCR) tests can detect the emerging Omicron variant of the virus that causes COVID-19, according to the World Health Organization.

The European Union's in vitro diagnostic expert panel has published its first opinion on an In Vitro Diagnostic Medical Devices Regulation (IVDR) submission, delivering a glowing opinion of the filing for a test to screen plasma donor samples for hepatitis E virus (HEV).

The world is in a "race against time" with the Omicron coronavirus variant, said European Commission President Ursula von der Leyen on Sunday, warning during a visit to Latvia that scientists and manufacturers will need weeks to fully understand the new variant.