Different medical institutions have selected different imported and domestic brand instruments: 38 domestic and 58 imported.

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

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.

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.