Diasorin (FTSE MIB: DIA) announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company’s NxTAG® Respiratory Pathogen Panel (RPP) v2. This updated panel, an addition to Diasorin’s expanding molecular multiplexing portfolio, responds to customer needs by enhancing test usability.

Published by Springer-Verlag, In Vitro Diagnostic Industry in China is a specialized English monograph that fills a gap and provides a detailed introduction to the history, current status, outstanding companies and products of China's IVD industry.

Instead of a traditional speculum-involved pelvic exam to screen for cervical cancer, the US Food and Drug Administration has given the go-ahead for patients to have the option to collect their own vaginal samples for screening in a health care setting, such as at their doctor’s office, an urgent care or even a mobile clinic.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the FDA approval of its human papillomavirus (HPV) self-collection solution, one of the first available in the United States. Screening for HPV can help identify women who are at risk of developing cervical cancer so that the disease can be found and treated early before cervical cancer has a chance to develop.

As of 30 April 2024, there were 82 Chinese IVD listed companies, of which 61 were listed companies with main IVD business (IVD business accounted for more than 50% of the total business), and 21 were listed companies with IVD-related business.

The US Food and Drug Administration (FDA) has warned users not to use Cue Health’s at-home Covid-19 tests, just one week after the agency issued a warning letter saying that Cue was not following the conditions specified in the emergency use authorisations for its tests.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced an updated version of its clinical decision support platform, QIAGEN Clinical Insight Interpret for NGS molecular profiling of hereditary and somatic diseases, has received the European Union (EU) Technical Documentation Assessment and Quality Management System certificate under the European In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR).

Against the background of the current rapid development of life science and technology, with the development of clinical biochemical test technologies, there are more and more product categories and test items in the biochemical detection platform.

CareDx, Inc. (Nasdaq: CDNA) – today reported financial results for the first quarter ended March 31, 2024.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today reported financial results for the quarter ended March 31, 2024.

The Board of Directors of DiaSorin S.p.A. (FTSE MIB: DIA), examined and approved the Group’s Consolidated Financial Statements at March 31, 2024.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today reported its financial results for the first quarter ended March 31, 2024.

Danaher Corporation (NYSE: DHR), a global science and technology innovator ("Danaher"), today launched a collaboration with Johns Hopkins University aiming to develop new methods for diagnosing mild TBI. As part of the Danaher Beacons program, researchers at Johns Hopkins University will leverage technology from Beckman Coulter Diagnostics, a Danaher subsidiary and leader in clinical diagnostics, to potentially establish correlations between a new biomarker panel and clinical outcomes.