Seegene introduced Anyplex™ MDR-TB Screening Test, the first real-time PCR molecular diagnostic capable of simultaneous detection of TB and genetic mutations leading to multi-drug resistant TB (MDR-TB) within four hours.

Seegene Anyplex™ MDR-TB Test will be introduced at the 2010 Annual Meeting and Clinical Lab Expo of the American Association for Clinical Chemistry (AACC), booth #1800.

According to the World Health Organization (WHO), TB strains that are resistant to all major anti-TB drugs have been documented in every country by the non-governmental organization recent survey. A particularly dangerous form of drug-resistant TB is multi-drug resistant TB (MDR-TB), which is defined as the disease caused by TB bacilli resistant to, among others, the two most powerful anti-TB drugs, isoniazid (INH) and rifampicin (Rif).The rate for successful MDR-TB treatment is extremely low and the progress of the disease is faster than normal TB, resulting in 40-50% of mortality rate. Rates of MDR-TB are troublingly high in some countries, especially in the former Soviet Union, and threaten TB infectious disease control efforts. WHO estimates that more than 440,000 people are infected with MDR-TB.

Using Anyplex™ MDR-TB Screening Test, healthcare workers will be able to quickly determine whether or not a patient is infected with a strain of TB that is resistant to INH and Rif. The Anyplex™ MDR-TB is a real-time detection test of M. tuberculosis that quickly and comprehensively determines the levels of targets in a patient’s various sample types, and identifies mutations of drug resistant genes to better inform a diagnosis.

Because genetic mutations that lead to antibiotic resistance are minute and sit close together, so far conventional PCR or conventional real-time PCR tests are not able to discriminate these mutations accurately within the same test procedure. In contrast, the Anyplex MDR-TB test can detect the mutations of drug resistant genes to Rif (rpoB: D516V/Y, H526D/Y, S531L) and INH (katG: S315T (2 cases); inhA promoter: -15(C/T)). The unprecedented speed and accuracy of the Anyplex MDR-TB Tests will enable doctors and clinicians to quickly provide an appropriate treatment to prevent the spread of MDR-TB.

Seegene’s new MDR-TB test takes TB diagnostics to a new level. Current TB test methods are hindered by speed (culture typically required 2-8 weeks for results), low sensitivity (acid-fast bacilli smear microscopy produced results in 24 hours but at the cost of missing a significant portion of TB cases) and low specificity (culture and microscopy methods not being able to efficiently differentiate between M. tuberculosis and non-tuberculosis mycobacteria). Furthermore, none of these approaches are able to rapidly and efficiently identify a patient’s resistance to the major drugs for treating TB — INH and Rif. Even if sequencing and Line Probe Assay are available to test drug resistance, the procedures are quite complicated and time-consuming.

"Making a fast and accurate diagnosis of the type of TB infection a patient may have is the most important step to curing a patient. Because MDR-TB is difficult to treat, preventing its spread throughout the population is essential. The Anyplex™ MDR-TB Test is a powerful new tool that healthcare workers can use to rapidly determine MDR-TB infections, which will both help stop it from spreading and allow health care professionals to set a course of alternative medications for infected patients," said Jong-Yoon Chun, chief executive officer of Seegene.

Anyplex™ MDR-TB Test will not be available in the USA until regulatory clearance.

Source: Seegene