NEW YORK, Jan. 12 (GenomeWeb News) - The European Union's regulatory body cleared the CellCorrect Lab Detection Kit for clinical use, CeMines said today.
EU's State Agency of Medicines-Department of Medical Devices on Dec. 30, 2005, granted the CE Mark for the molecular blood test to detect and diagnose lung cancer. CeMines Estonia OU, a wholly owned subsidiary, filed for CE Mark registration in September 2005.
CeMines Estonia will market and distribute the test under the brand name CellCorrect KvA-40 LAb Kit.
CeMines filed a 501(k) application for CellCorrect Lab with the US Food and Drug Administration in May 2005. Claiming "productive discussions" with the FDA, the company expects "substantial forward progress" in 2006.