Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas® liat sexually transmitted infection (STI) multiplex assay panels. These panels, including tests for chlamydia and gonorrhea (CT/NG) and chlamydia, gonorrhea and Mycoplasma genitalium (CT/NG/MG), enable clinicians to diagnose and differentiate between multiple STIs with a single sample. These tests will be exclusively available in the U.S. market in the coming months, with commercialisation under CE mark expected to follow shortly.

High-throughput sequencing (HTS) has started to be applied in tumor companion diagnosis in recent years.

Kryptos Biotechnologies said this week that the Research Investment for Global Health Technology (RIGHT) Foundation has awarded it $1.2 million to further develop its molecular diagnostic testing system for use at the point of care.

The U.S. Preventive Services Task Force (USPSTF) recommends four types of screening for cancers: lung cancer, colorectal cancer, breast cancer, and cervical cancer.

OraSure Technologies, Inc. (“OTI”) (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced the acquisition of Sherlock Biosciences, Inc., a global health company bringing next-generation diagnostics to consumers and healthcare providers.

Akoya Biosciences on Tuesday said it has inked an exclusive global license agreement with German molecular diagnostics firm NeraCare to develop and commercialize NeraCare’s Immunoprint test for early-stage melanoma on Akoya's immunofluorescence platform.

In 2019, there were about ten million TB patients worldwide and 1.5 million deaths, and China ranks third in the world with 895,000 new cases of TB each year, most of which are pulmonary TB. The diagnosis of pulmonary TB is based on pathogen detection. Molecular diagnostic is one of the methods of pathogen detection, and the target of the test is the Mycobacterium tuberculosis complex (MTBC). Most of the molecular diagnostic reagents for tuberculosis are based on fluorescent PCR technology.

Latent tuberculosis infection (LTBI) is defined as a state of persistent immune response to stimulation by Mycobacterium tuberculosis antigens with no evidence of clinically manifested active TB.

The World Health Organization (WHO) has granted prequalification to the molecular diagnostic test for tuberculosis (TB) called Xpert® MTB/RIF Ultra. It is the first test for TB diagnosis and antibiotic susceptibility testing that meets WHO's prequalification standards.

In 2020, the DNBSEQ-T7 Gene Sequencer of Wuhan MGI Technology Co., Ltd. (hereinafter referred to as “MGI”) was approved (Registration No.: G.X.Z.Z. 20,203,220,061).