The US Food and Drug Administration has granted 510(k) clearance and a CLIA waiver to a multiplex assay from Visby Medical to detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The assay uses an instrument-free, single-use PCR device.

A federal jury on Friday ruled that Qiagen willfully infringed two patents owned by ArcherDx (now part of Invitae) and Massachusetts General Hospital and ruled that Qiagen must pay royalties and lost profits totaling about $4.7 million.

MDxHealth reported Thursday after the close of the Belgian stock exchange that its revenues for the first half of 2021 increased 9 percent year over year.

AccessDx Holdings said Wednesday that it has acquired 2bPrecise, a service and technology provider that integrates genetic and genomic test results into electronic health records, from EHR giant Allscripts Healthcare Solutions for an undisclosed amount.

Becton Dickinson announced Wednesday that it has received US Food and Drug Administration approval for its automated, sample-to-answer, high-throughput BD Cor system along with the BD Onclarity HPV Assay for extended genotyping of human papillomavirus.

AnPac Bio-Medical Science, a cancer screening and detection company, said on Monday that it has filed for registration testing of its Class III, multi-cancer detection device with China's National Medical Products Administration.

Point-of-care diagnostics firm LumiraDx and special purpose acquisition company CA Healthcare Acquisition said on Monday that they have revised the terms of their previously announced merger to lower the equity value of the combined company.

Partek said that it has entered into an agreement with Santa Clara, California-based Agilent Technologies to integrate its Partek Flow bioinformatics software with the Agilent Alissa Clinical Informatics platform, providing an end-to-end analysis workflow that is customizable for Agilent's customers

South Korean diagnostics company Seegene on Wednesday reported a nearly 11 percent year-over-year increase in its second quarter revenues amid higher sales of its infectious disease testing reagents and PCR equipment in Europe and North America.

Tempus said on Tuesday that it has submitted a premarket approval application for its next-generation sequencing-based xT-Onco tumor profiling assay to the US Food and Drug Administration.