Seegene, Inc. Announces New FluA Subtyping Test

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Rockville, MD, August 31, 2009 – Seegene today released a new influenza A sub-type screening test, Seeplex® FluA ACE Subtyping, that enables simultaneous detection of pandemic novel influenza A (H1N1), seasonal human influenza A H1, seasonal human influenza A H3 and avian influenza A H5 in a single reaction. The Seeplex FluA ACE subtyping test is based on the company’s novel DPOTM-based Multiplex RT-PCR technology, and is in accordance with the World Health Organization (WHO) guidelines for diagnosis of new virus strains.

Currently screening kits available to national health organizations bracing for an expected influenza pandemic this autumn test separately for one viral strain, some using the immunochromatography method, commonly known as ‘rapid test.’ This testing methodology is not being adopted as a standard method due to its low accuracy.

Furthermore, the U.S. CDC provides a real-time PCR protocol with primers and probe sequence information, but this approach can confirm only pandemic novel H1N1 type by conducting four different single-targeted PCR tests of each patient sample.

In contrast, Seegene’s new FluA subtyping test enables simultaneous detection of 4 major influenza A subtypes, including current pandemic novel H1N1, at a price point that makes it a viable tool for thorough mass screenings of a population.

Accurate diagnosis for an exact type of influenza virus A is essential in the coming flu season. While all types of influenza have similar symptoms, the correct antiviral drug must be prescribed for efficacious treatment. Two groups of anti-influenza drugs are currently available, the neuramidase inhibitors (Tamiflu and Relenza), and the M2 inhibitors (Amantadine and Rimantadine).

Because 94% of seasonal influenza A virus type H1 are resistant to Tamiflu, patients infected by this pathogen should be treated with a more appropriate therapy. Better targeting of therapies will prove to be a crucial defense strategy as widespread prescription of a treatment can provoke the early development of resistant variants, rendering an antiviral drug ineffective.

“Accurate testing using our new FluA ACE subtyping kit to match viral strains with antiviral therapies can become a game-changing strategy for many national health organizations,” said Dr. Jong-Yoon Chun, Founder and Chief Executive Officer, Seegene.

“Screening a patient population experiencing the onset of novel flu strains will be complicated by patients presenting with more common, but equally menacing, seasonal illnesses, such as pneumonia. Once a patient becomes infected by a respiratory virus they are vulnerable to successive infections by bacteria causing pneumonia,” added Dr. Chun.

Typically pneumonia patients are treated with antibiotics, yet if a patient infected with bacterial pneumonia is treated with an antiviral drug, the patient can develop serious complications, especially more vulnerable populations such as children, the elderly and individuals with immuno-suppressed conditions.

In the mass screening setting, due to similar symptoms between various respiratory diseases, it can be critical to simultaneously diagnose both new influenza A and bacterial pneumonia to determine the right treatment. The usual detection process at hospitals for pneumonia is the culture method requiring 4-5 days for a result, and which may leave some bacteria undetected.

To remedy this situation Seegene has now developed bacterial pneumonia tests capable of simultaneously detecting viral pneumonia and the new Influenza A virus.

This past month, the Korean government approved Seegene’s multiplex RT-PCR method as a confirmation test for social health insurance. More than 50 university hospitals, including Seoul National University hospital, and major reference laboratories adopted Seegene’s Multiplex RT-PCR respiratory virus detection method.

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