Seegene Introduces Anyplex plus MTB/NTM/DR-TB Real-time Test, a One-stop Solution for Diagnosing Tuberculosis

Seegene announce the release of Anyplex™ MTB/NTM/DR-TB Real-time Test, multiplex diagnostic test simultaneously identifies tuberculosis, non-tuberculosis mycobacterium, multidrug-resistant TB (MTB), and extensively drug-resistant TB. The new test will be showcased 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.

The new Anyplex™ MTB/NTM/DR-TB Real-time Test provides a solution for the diagnosis and treatment of mycobacteria infections. Anyplex MTB/NTM/DR-TB detects non-tuberculosis mycobacteria, and the presence of key resistance mutations to anti-MTB drugs in a single test.

The Anyplex™ MTB/NTM/DR-TB detects MTB and discriminates it from NTM in less than 2 hours. In the case of MTB-positive, further analysis for drug-resistance to Isoniazid (INH), Rifampicin (RIF), all fluoroquinolone (FQ), and the injectable drugs (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. 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 thesemutations. However, with Anyplex™ 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.

Anyplex™ MTB/NTM/DR-TB Real-time Test will not be available in the USA until regulatory clearance is obtained.