Seegene, Inc. Introduces Highly Sensitive Multiplex Tuberculosis Detection

ROCKVILLE, MD--(Marketwire - March 03, 2009) - Early detection and treatment of tuberculosis (TB) is an international health care priority, as rapidly migrating populations in a globalized economy ensure the continuation of this highly treatable disease. TB is highly contagious and requires early testing to initiate treatment, improve patient outcomes, interrupt transmission of the disease and put into place more effective public health interventions. Seegene promises to help achieve earlier laboratory confirmation of the TB pathogen (Mycobacterium tuberculosis) with its introduction of Seeplex® MTB ACE detection test. Seeplex® MTB ACE provides simple and fast detection in a single multiplex PCR that uses multiple genetic targets -- IS6110 and MPB64.

TB is a significant enough threat to public health worldwide to warrant the US Centers for Disease Control (CDC) to recognize the importance of prompt laboratory results in TB diagnosis and control, and to convene a panel to evaluate and draw up guidelines to testing approaches to the disease. The World Health Organization (WHO) has even established a “Stop TB Strategy” program with the goal of eliminating tuberculosis by 2015; testing and detection of TB in a fast and accurate manner will be a key to success.

Seegene’s new TB test aims to be helpful tool in these eradication efforts by offering a significant improvement over previous testing methods. For example, current methods are hindered by speed (culture typically required 2-8 weeks for results) and 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 differentiate between M. tuberculosis and non-tuberculosis mycobacteria).

The Seeplex MTB ACE detection test uses a single multi-target amplification for specific detection of M. tuberculosis, and is based on the company’s novel DPO™ (Dual Priming Oligonucleotides) PCR technology. IS6110 is the most widely used target gene for detecting M. tuberculosis, however several M. tuberculosis strains lack the insertion sequence IS6110. By simultaneously amplifying IS6110 and MPB64, Seeplex MTB ACE is able to identify infections that would otherwise go undiagnosed in a procedure that produces no false positive and false negative results.

The Seeplex MTB ACE Detection detects both extra-pulmonary and pulmonary TB from various specimens, such as sputum, body fluid, bronchial washing, urine, stool, CSF, and bone marrow aspiration. Another important feature of the test is that internal control is co-amplified and co-detected with M. tuberculosis. When detecting M. tuberculosis from various specimens PCR inhibition can occur, resulting in false negative results. The internal control minimizes erroneous test results.

In a study highlighted at the 49th Annual Meeting of the Korean Society for Laboratory Medicine 2008, a Korea-national university hospital tested 188 respiratory specimens for TB using culture, AFB stain, Roche’s Amplicor MTB and the Seeplex MTB ACE test. This study concluded that Seeplex MTB ACE test was more sensitive with higher specificity than the Amplicor PCR test, while having the same reaction time as the Amplicor test.

In addition to the new Seeplex MTB ACE Detection, Seegene offers three other products for detecting M. tuberculosis:

-- Seeplex MTB/NTM ACE Detection uses culture sample to differentiate between M. tuberculosis and non tuberculosis mycobacteria (NTM) group. -- Seeplex MTB Nested ACE Detection guarantees the highest sensitivity using paraffin-embedded tissue, fresh tissue or CSF. -- Seeplex MTB/BCG ACE Detection is specially designed to discriminate between M. tuberculosis and M. bovis BCG, which is an attenuated strain of M. bovis that is used for vaccination. Even though the symptoms from either infection of M. tuberculosis or M. bovis BCG are similar, the treatment is different. Therefore, the incidence of prescribing wrong medicine can happen resulting in developing drug resistance to the infection. 

About Seeplex® System: Frontier of Multi-pathogen Detection

Seeplex is a breakthrough multiplexing PCR technology that enables a new standard in simultaneous multi-pathogen detection. Seeplex works in combination with automatic detection systems such as capillary electrophoresis and delivers a benchmark in testing accuracy, efficiency and cost-effectiveness.

About Seegene

Seegene, Inc. is a biotechnology company specialized in molecular diagnostics and research applications. It holds a novel detection platform named “Seeplex,” which sets a standard in high-throughput and simultaneous multi-pathogen detection called “multiplexing.” Seeplex technology accurately detects multi-pathogens with high-throughput speed, ultimately providing the most economical basis for saving time, labor and cost. Seegene develops, manufactures and markets innovative molecular diagnostic products and services to a worldwide community. The company has more than 47 distributors in 28 countries, including 2 subsidiary offices in the US and Japan. Its mission is to maintain leadership in molecular diagnostics for infectious diseases, genetics, pharmacogenetics, and oncology, and chromosomal analyses using innovative proprietary technologies. For more information please visit www.seegene.com or call +301-762-9066.