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).

Xcell Therapeutics is expanding the business scope of its exosome isolation and purification device, “EXODUS,” into the diagnostics market.

Alveo Technologies, Inc. (Alveo), a leader in decentralized molecular diagnostics with its proprietary IntelliSense™ molecular detection technology, today announced that it received an agreement issued by the United States Centers for Disease Control and Prevention (CDC) on a competitive basis to develop a rapid, molecular, point of need diagnostic to detect and differentiate between Influenza A + B, and A/H5 in humans.

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.

In 2020, NMPA approved 18 types of class III molecular diagnostic instruments, and the provincial medical product administration approved 11 types of class II molecular diagnostic instruments, a total of 29.

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.

The clinical application of molecular diagnostic technology is mainly in the form of detecting nucleic acid markers, including reagents and instruments, which are regulated by the National Medical Product Administration (hereinafter referred to as NMPA).