Seegene announced that Anyplex™plus MTB/NTM/DR-TB Real-time Test, a total solution for diagnosing Mycobacterium tuberculosis (MTB), was introduced at the 2011 Annual Meeting and Clinical Lab Expo of the American Association for Clinical Chemistry in Atlanta, GA, July 26-28, 2011.
Every year 9.4 million people are newly infected with MTB, and 1.7 million people die yearly from the disease. The emergence and spread of drug-resistant MTB threatens global MTB control efforts, and there is an urgent need for a one-stop diagnostic test that rapidly detects and differentiates MTB from non-tuberculosis mycobacteria (NTM), and detects resistance associated mutations to various anti-MTB drugs.
Seegene's new product, Anyplex™plus MTB/NTM/DR-TB Real-time Test, provides a one-stop solution in the diagnosis of -- and treatment selection for -- mycobacteria infections. Anyplex plus MTB/NTM/DR-TB detects Mycobacterium tuberculosis, non-tuberculosis mycobacteria, and the presence of key resistance mutations to anti-MTB drugs in a single test.
The Anyplex™plus MTB/NTM/DR-TB firstly detects MTB and discriminates it from NTM in less than 2 hrs. In the case of MTB-positive, further analysis for drug-resistance to Isoniazid (INH), Rifampicin (RIF), all fluoroquinolone (FQ), and the injectable drugs (i.e., amikacin, kanamycin, or capreomycin) is performed to identify whether the MTB is multi drug-resistant MTB (MDR-TB), or extensively drug-resistant MTB (XDR-TB) in less than 40 min. In the case of NTM-positive, the identification of the three most associated with human disease, M. avium complex (MAC), M. kansasii, and M. abscessus, is carried out. This testing process will provide an effective one-stop diagnostic workflow for prompt mycobacteria detection and treatment.
Seegene's innovative DPO™ and READ technologies enable the test to perform multi-target detection with high specificity and sensitivity. There are a multitude of genetic mutations in MTB that are associated with drug resistance. To date conventional PCR methods have not been able to accurately discriminate all of these mutations. However, with Anyplex™plus MTB/NTM/DR-TB each drug-resistant mutation targeted is amplified by the corresponding DPO primer pair and detected specifically by READ technology, which is neither a probe-based method nor a melting temperature analysis method.
"Making an accurate diagnosis quickly is crucial to curing a MTB infection and limiting its spread to others. By providing a 'one-stop' test for MTB and MTB drug resistance based on the DPO and READ technologies, the Anyplex™plus MTB/NTM/DR-TB Real-time Test gives healthcare workers a powerful tool for rapid detection of a comprehensive range of MTB strains and mycobacteria," said Dr. Jong-Yoon Chun, Chief Executive Officer of Seegene.
Anyplex™plus MTB/NTM/DR-TB Real-time Test will not be available in the USA until regulatory clearance is obtained.