China will adjust tariffs on imported U.S. products from 12:01 p.m. Wednesday, the Customs Tariff Commission of the State Council announced on Tuesday.

The immunoassay segment accounts about 35% of the market, with no growth compared to the previous year. Domestic brands account for over 35%.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). The certification from TÜV SÜD Product Service is for tumor mutation profiling in patients with any solid cancerous tumor and for companion diagnostic indications to identify patients who may benefit from certain targeted therapies for advanced non-small cell lung cancer and breast cancer.

The UK Medicines & Healthcare Products Regulatory Agency on Tuesday published a proposed framework for the recognition of in vitro diagnostics that have already been cleared in other jurisdictions.

With the application of the latex-enhanced immunoturbidimetry and the enzyme immunoassay amplification, the sensitivity of biochemical test items is greatly improved. Representative products applied in the biochemical technology platform in 2019-2020 are as follows:

The American Society of Clinical Oncology on Friday released guidelines to help guide use of multigene germline genetic testing panels for cancer patients.

Karius®, Inc., a leader in genomic diagnostics for infectious diseases, announced today that the Karius Test® has been granted designation as a Breakthrough Device from The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA), for use in the diagnosis and management of immunocompromised patients with suspected lung infections including lower respiratory infection and pneumonia.

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

OSF HealthCare, a 16-hospital integrated health system that serves patients in Illinois and Michigan, and DELFI Diagnostics, Inc., a developer of accessible blood-based tests that deliver a new way to enhance cancer detection, today announced a collaboration to utilize DELFI's FirstLook Lung blood-based cancer screening test to help improve screening rates. DELFI's collaboration with OSF was recently highlighted by the Biden Cancer Moonshot to expand accessibility to lung cancer screening.

CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced findings from the SHORE (Surveillance HeartCare Outcomes Registry) study, one of the largest heart transplant studies of its kind, published in The Journal of Heart and Lung Transplantation.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the launch of its first trimester preeclampsia screening test to be performed between 11 and 14 weeks gestation to determine the risk of developing preeclampsia before 34 weeks of pregnancy. It is the only test of its kind available in the United States and is relevant for all pregnant individuals, including those with a low- to average-risk for preeclampsia or first-time pregnancies.

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.