On February 6th, the Equipment Review Center of the National Medical Products Administration released the results of the priority approval application for medical devices (No. 2 of 2025), and the products of Aoran Biotechnology (Shanghai) Co., Ltd. (hereinafter referred to as "Aoran Biotechnology") - Mycobacterium tuberculosis complex and rifampicin resistant nucleic acid detection kit (PCR fluorescence probe method) entered the priority approval green channel.

It is worth mentioning that this product belongs to the category of medical devices listed in the National Science and Technology Major Special Project, and is also the 7th IVD related product to enter the priority channel this year.

Domestic pioneering technology
At present, tuberculosis is still one of the most widely spread and lethal infectious diseases in the world. China is the second country with high burden of tuberculosis in the world. The World Health Organization has proposed the action goal of ending the prevalence of tuberculosis by 2035, and China has also released the Action Plan to Stop tuberculosis (2019-2022). However, there are still many difficulties in tuberculosis prevention and control, and achieving the goal of ending the prevalence of tuberculosis by 2035 faces serious challenges.

The diagnosis of tuberculosis is mainly based on pathogenic detection. The commonly used pathogen detection methods include sputum smear microscopy, mycobacterial isolation and culture detection, and molecular biology detection. Sputum smear microscopy has simple operation, rapid detection, and low hardware requirements, but its sensitivity and specificity are relatively low; The isolation, cultivation, and detection of Mycobacterium have high sensitivity and are the gold standard for laboratory diagnosis of pulmonary tuberculosis, but the detection cycle is too long; The timeliness of molecular biology technology is superior to sputum smear microscopy and mycobacterial isolation and culture methods, and it has high sensitivity and specificity.

The products entering the green channel this time - Mycobacterium tuberculosis complex and rifampicin resistant nucleic acid detection kit (PCR fluorescence probe method) adopt the first seven color fluorescence system in China, which can achieve multi-target detection in one tube, greatly improving the efficiency of tuberculosis detection. Moreover, its nucleic acid extraction and amplification analysis are fully automated, avoiding human errors, with good repeatability of results, and can be tested on a single sample at any time.

In addition, the results of the kit are accurate, and internal standard quality control is involved in the entire process, including ultrasonic lysis, magnetic bead nucleic acid extraction, and fluorescence PCR analysis. The reagent has high sensitivity, good specificity and multiple detection, and can be used for early and rapid diagnosis of tuberculosis and drug resistance detection. The innovative technological advantages of convenient operation, efficient detection and accurate results make the diagnosis of tuberculosis more widely used and help to achieve the goal of ending tuberculosis as soon as possible.

According to the description of Aoran Biology, the reagent kit is equipped with Galaxy's fully automatic nucleic acid detection and analysis system under the contract company. With only 4 steps of operation, the entire process of nucleic acid extraction, purification, and fluorescence PCR amplification can be fully automated and enclosed. It is suitable for auxiliary detection of tuberculosis infection and rifampicin resistant mutations.

It is worth mentioning that the reagent kit has been certified for medical device registration in Thailand in September 2023.

Focusing on real-time molecular diagnostic technology
Founded in 2015, Aoran Biotechnology focuses on real-time molecular diagnostic technology. As a representative of the molecular POCT platform, it has exclusive advantages in seven color fluorescence, platform open compatibility, and market competitiveness. So far, we have successfully developed a series of fully automated detection devices, reagents, intelligent reagent kits, and supporting fully automated production lines suitable for microbial detection, personalized drug genetic testing, cancer detection, forensic evidence, food safety, and other fields. Widely used in medical institutions at all levels, disease control centers, third-party forensic centers, inspection and quarantine bureaus, etc.

At present, the fully automatic and fully sealed fluorescence PCR analysis system independently developed by Auran Biotech conforms to the development trend of global molecular diagnostics "Sample in, Results Out". As a representative of the new generation PCR technology platform, it has technical advantages and market competitiveness, and is widely used in various levels of medical institutions, disease control centers, third-party clinical inspection institutions, forensic centers, inspection and quarantine bureaus, etc.

According to the official website of Auran Biotech, its product pipeline is currently relatively rich, divided into seven categories: instruments, manual nucleic acid extraction reagents, forensic reagents, intestinal disease detection reagents, sexually transmitted disease detection reagents, respiratory disease detection reagents, and insect borne infectious disease detection reagents, as well as Galaxy fully automatic nucleic acid detection and analysis system and Sniffer fully automatic nucleic acid detection and analysis system.

At the Medlab 2025 conference that ended yesterday, Aoran Biotech showcased multiple products. In addition to the Galaxy fully automated nucleic acid detection and analysis system mentioned earlier, it also showcased its heavyweight technology - iCasette ® Smart box.

It is reported that, iCassette ® The smart box has unique openness and compatibility, which can integrate third-party traditional fluorescent PCR detection reagents into the smart box to form an integrated molecular POCT detection product, greatly saving development time and costs. In conjunction with the Galaxy fully automated nucleic acid testing and analysis system, the entire process of nucleic acid testing is completed in a fully enclosed and integrated manner. It is widely used in diverse scenarios such as medical institutions at all levels, disease control centers, third-party inspection agencies, forensic centers, and inspection and quarantine bureaus for rapid pathogen nucleic acid testing.

Conclusion
As a leader in real-time molecular diagnostics, Auran Biotech's independently developed technology has obtained more than 140 intellectual property patent authorizations at home and abroad, and its products have obtained nearly 120 domestic and foreign medical device registration certificates or access licenses.

Source: https://news.yaozh.com/archive/44950.html