Molecular diagnosis is performed at the gene level with nucleic acids as the object for detection, with high sensitivity and accuracy.

Gene Solutions and Topgen Biomedical Technology said Thursday that they have entered a partnership under which Shaoxing, China-based Topgen will offer various genomic tests developed by Gene Solutions for cancer early detection and monitoring.

QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or “QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, today announced a refocusing of its molecular diagnostics strategy. This strategy includes the intent to acquire full ownership of LEX Diagnostics after 510(k) clearance by the U.S. Food and Drug Administration ("FDA") for consideration at closing of approximately $100 million and plans to discontinue the Company's Savanna platform development.

Singapore-based microRNA diagnostics firm MiRxes said Thursday that it has launched an initial public offering on the Hong Kong Stock Exchange, selling 46,620,000 Hong Kong offer shares and 41,958,000 international offer shares at HK$23.30 (US$2.98) per share for approximately HK$880.5 million (US$112.8 million) in net proceeds.

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

The World Health Organization on Thursday issued the first global guidelines for meningitis diagnosis, treatment, and care.

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.