bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid has obtained clearance from the U.S. Food and Drug Administration (FDA). This midplex molecular panel tests for 11 of the most common bacteria, viruses, and parasites associated with gastroenteritis — all from one sample, with results available in approximately one hour.

Abbott last week received 510(k) clearance from the US Food and Drug Administration for its self-collected molecular test for sexually transmitted infections.

In 2019, the BRCA1 and BRCA2 Gene Mutation Detection Kit (Reversible Terminator Sequencing) of Xiamen Amoy Diagnostics Co., Ltd. was approved.

Inflammatix, a pioneering host response diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the TriVerity™ Test System (TriVerity), a first-in-class molecular test for patients with suspected acute infection or sepsis. Using precise measurements of a patient’s immune response, TriVerity combines highly accurate bacterial-viral infection scoring with an all-cause illness severity risk evaluation, giving clinicians a rapid and holistic snapshot of a patient’s status.

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.