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.

bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel has received U.S. Food and Drug Administration (FDA) Special 510(k) clearance. This innovative polymerase-chain reaction (PCR) testing solution offers fast and accurate pathogen identification in patients with unexplained fever, helping to optimize treatment overall.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of two new tools for designing and ordering custom solutions that can be used to support microbial analysis of bacterial, fungal and viral targets.

QIAGEN today announced the inclusion of the QIAcuityDx digital PCR System in the Australian Register of Therapeutic Goods (ARTG). This pivotal addition to QIAGEN’s portfolio is now expanding digital PCR into clinical diagnostics, enabling labs to harness its precision and efficiency for applications in oncology and infectious diseases. The instrument and accessories are IVDR-certified.

The miniaturization of fluorescent PCR instruments is also a trend. Small PCR cyclers are portable and realize mobile detection.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Meningitis/Encephalitis Panel for clinical use.

According to the statistics published on the website of the NMPA, in 2020, NMPA approved eight models, one is for fluorescent PCR data analysis, one is for chip data analysis, five are for sequencing data analysis, and one is for interpretation of tumor and genetic disease gene detection results.

Seegene Inc., a leading South Korean company providing a total solution for PCR molecular diagnostics, announced today the finalization of a partnership agreement with Werfen, a worldwide leader in specialized diagnostics, on the technology-sharing initiative. Under the agreement, Seegene and Werfen will set up a NewCo in Spain, Werfen-Seegene, upon the conclusion of mandatory government approvals anticipated by the first half of 2025.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the cobas® Respiratory flex test, the first to use Roche’s novel and proprietary TAGS (Temperature-Activated Generation of Signal) technology.

Seegene Inc., a leading provider of total solution for PCR molecular diagnostics based in South Korea, announced today that it will introduce a new type of research-use-only (RUO) PCR assay to address the spread of the mpox virus variant, Clade Ib, which is currently prevalent in Africa.