Melbourne, Dec 17, 2007 (ABN Newswire) - Cellestis Limited (ASX: CST) is pleased to announce it has been advised by the Korean Food and Drug Administration (KFDA) that QuantiFERON(R)-TB Gold In-Tube has received regulatory approval in the Republic of Korea (South Korea); allowing sale of the test in the Republic of Korea.
This approval comes after detailed examination of the regulatory submission by the regulatory authorities of the Republic of Korea. Cellestis will market the test in the Republic of Korea via its distributor, Woongbee MeDiTech Inc., who has been instrumental in obtaining the regulatory approval.
The prevalence of tuberculosis in the Republic of Korea has been reported as 135 per 100,000 pop/yr and BCG vaccination is mandatory. South Korean researchers have shown a keen interest in QFT and have utilised the test in clinical trials in different TB testing populations, such as health care workers and the military.
"We are pleased by this approval and the availability of QFT in South Korea expands the Asian market." said Dr Tony Radford, CEO of Cellestis. "We are very grateful for the assistance provided by Woongbee MeDiTech Inc, in navigating the intricacies of the regulatory process and look forward to working with them to develop and grow the market. The regulatory approval involved detailed analysis of the clinical performance and quality compliance of our test, and is another official ratification of QFT. South Korea now joins the growing list of countries that have approved QFT."
Details on Woongbee MeDiTech Inc. may be found on: http://www.woongbee.com and within South Korea they may be contacted on 031 776 330
Cellestis is a listed Australian biotechnology company commercializing QuantiFERON(R) technology for diagnosing tuberculosis and other diseases worldwide. QuantiFERON(R)-TB Gold tests for the presence or absence of a protein (gamma-interferon) produced by a patient's white blood cells after stimulation with specific tuberculosis proteins. The test has received regulatory and policy approvals in the USA, Japan, Europe and elsewhere. The Company operates through subsidiaries in the USA, Europe, Australia and Japan.