Gene-modified TB diagnosing drug gets market approval in China

HEFEI -- A gene-modified diagnosing drug for testing mycobacterium tuberculosis infections (MTI) has attained China's new drug certificate and production license.

Anhui Zhifei Longcom Biopharmaceutical Co Ltd, the developer of the new product, said the new product can avoid false positives for MTI when a person has received a BCG vaccine, a 100-year-old vaccine for preventing serious forms of tuberculosis.

It is estimated that about a quarter of the world's population is infected with mycobacterium tuberculosis, according to a report by the World Health Organization in 2019. Around 5 to 10 percent of the infected may break down with the disease, while others remain clinically latent. Effective mycobacterium tuberculosis diagnosis is the first step to eradicating the disease worldwide.

"The new product makes the early detection and treatment of tuberculosis possible. It also provides an effective way to conduct mass population screening for the disease," said Cheng Shiming, secretary general of the Chinese Antituberculosis Association.

Pu Jiang, general manager of the company based in East China's Anhui province, said researchers use gene recombination technology to fuse and express ESAT6-CFP10 protein with the product, which can detect the pathogen by a skin test and distinguish it from BCG vaccinations.

He said countries with high incidences of tuberculosis such as the Philippines, Indonesia and Brazil have contacted the company, hoping to introduce the product to their markets.