Seegene Introduces First Real-time Molecular Diagnostic Test for Tuberculosis and Multi-drug Resistant Tuberculosis

ROCKVILLE, MD and SEOUL, KOREA–(Marketwire – July 21, 2010) – The emergence and spread of drug-resistant mycobacterium tuberculosis (TB) threatens global TB control efforts, and there is an urgent need for new diagnostic tests that rapidly identify drug sensitivity profiles of TB strains. To help address these concerns, Seegene today 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.

About Seegene

Seegene, Inc. is the leading biotechnology company developing, manufacturing and marketing innovative molecular diagnostic products. The company’s proprietary technologies in both PCR and Real-time PCR named ACP™, DPO™, and READ™, set a new solution for high-throughput and simultaneous multi-pathogen detection called “multiplex PCR”. The novel Real-time PCR technology, READ™, overcomes the limitations of conventional Real-time PCR, providing dramatic improvement in sensitivity and specificity. Seegene holds three novel Molecular diagnostic platforms: Seeplex^®  system adapting DPO™ Technology, Anyplex™ and Magicplex™ systems that are Real-time PCR detection platforms adapting DPO™ and READ™ technologies. Seegene’s products detect multi-pathogens with great reliability and throughput, ultimately providing the most economical basis for saving time, labor and cost. Seegene’s mission is to maintain leadership in molecular diagnostics for infectious diseases, genetics, pharmacogenetics, and oncology using the innovative proprietary technologies.

For more information please visit www.seegene.com or call +301-762-9066.