Seegene said Wednesday that it has obtained CE marking for the use of its Combo Swab self-collection device with four of the firm's SARS-CoV-2 molecular diagnostic assays, enabling its use in the EU and other regions that accept the designation.

As of the end of August 2021, the first-half reports of IVD-related listed companies have basically been released. 64 IVD-related listed companies have achieved steady growth in the first half of 2021, and more than 70% of companies have shown positive growth in net profits.

The second quarter revenues of Burning Rock Biotech were up 19 percent year over year. The Chinese precision oncology firm recorded total revenues of RMB 127.3 million ($19.7 million) for the three months ended June 30, 2021, up from RMB 107 million for the same period in 2020.

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.

On August 17th, Autobio released a semi-annual performance report stating that the operating income was 1.678 billion yuan, an increase of 39.13% year-on-year; the net profit attributable to shareholders of listed companies was 413 million yuan, an increase of 50.63% year-on-year.

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.

LumiraDx reduced the terms of the valuation for its SPAC merger from $5 billion to$3 billion citing a decline in COVID-19 testing

The US Food and Drug Administration this week granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Mount Sinai Hospital and Empire City Laboratories.

Genetron Health collaborates with Yikon Genomics, expanding S5 Platform's reach to reproductive health field; AmoyDx collaborates with Amgen to develop companion diagnostics for Japan market; AcornDx collaborates with BGI to develop accurate diagnosis on urinary system tumors

Thermo Fisher Scientific said on Wednesday that the US Food and Drug Administration has granted pre-market approval to the company's Oncomine Dx Target Test as a companion diagnostic to identify patients with isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma (CCA) who may be candidates for treatment with ivosidenib (Servier Pharmaceuticals' Tibsovo).

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.

August 25, Mindray (300760.SZ) announced financial results for the first half ended June 30, 2021. The first-half sales of CNY 12.778 billion increased 20.96% year-on-year. The net earnings attributable to common stockholders was CNY 4.344 billion, increasing 25.79% than the one in the last 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.

On August 20, Fosun Diagnostics, a holding subsidiary of Fosun Pharma, signed the investment agreement with Suzhou Abcarta. After the completion of the transaction, Fosun Diagnostics will hold about 58.67% equity of Suzhou Abcarta.