Perceptronix Received Medical Device Licenses for CLEARCYTE™ and CLEAR2C™ From Health Canada
February 8, 2006
VANCOUVER, CANADA (February 8, 2006) – Perceptronix Medical Inc. (“Perceptronix”) announced today that it has been issued Medical Device Licenses from Health Canada for its first two products – the ClearCyte™ Quantitative Cytology System and its associated Clear2C™ Quantitative DNA Staining Kit. Perceptronix can now market these two products in Canada.
ClearCyte™ is a high throughput automated image cytometer used to measure DNA properties in cell samples of different tissues, such as bladder washings, breast nipple aspirates, oesophagus touch preparations, bronchial washings/brushings, oral brush-biopsies, etc. Combined with interactive review of cells, ClearCyte™ tests may provide pathologists with valuable information related to the clinical diagnosis and prognosis of cancer.
ClearCyte™ has also recently received CE Mark allowing it to be marketed in the European Union.
Clear2C™ is a Quantitative DNA Staining Kit, designed to deliver convenient, repeatable and reliable DNA staining for absorbance microscopy. While optimized for DNA quantification with ClearCyte™, it may also be effectively used with other cytometry platforms. Perceptronix has also recently filed for a CE Mark for Clear2C™.
“We are delighted to have gained the market access these licenses imply and are very impressed with Health Canada’s efficiency in dealing with these two applications,” said Dr. Bojana Turic, Perceptronix Vice President and Director of Clinical and Regulatory Affairs. “ClearCyte™ is designed for high throughput clinical laboratory testing and will be a core offering of the Quantitative Pathology Services Laboratory that Perceptronix plans to open in Vancouver early this year. The Health Canada Medical Device License is a requirement for the commercial offering of ClearCyte™ DNA tests.”
“Receiving these Medical Device Licenses from Health Canada is of paramount importance to Perceptronix because we are operating in a global market. Potential customers outside of Canada closely scrutinize a medical device’s acceptance by its country-of-origin marketplace and regulators,” added Dr. David Garner, Perceptronix President and Chief Operating Officer.
About Perceptronix Medical Inc. (www.perceptronix.com) Perceptronix (Vancouver, Canada) is developing a suite of technologies to approach cancer diagnosis comprehensively: early detection, localization, diagnosis and follow-up. The first of these to receive regulatory approval are ClearCyte™ Quantitative Cytology System and its associated Clear2C™ Quantitative DNA Staining Kit which assist physicians with clinical diagnosis and prognosis of cancer. The Perceptronix product pipeline also includes ClearSign™, a sputum based early lung cancer detection test, ClearVu™ and ClearVu™ Elite simultaneous and spectral fluorescence/white light endoscopy systems, and ClearPath™, an aid to definitive diagnosis of biopsy sections. Perceptronix
commercializes early cancer detection technologies developed in partnership with the BC Cancer Agency (www.bccancer.bc.ca), a world-leader in cancer care and research, with a particularly notable track record in pioneering early cancer detection programs.
Contact:
Susan Grose, Corporate Secretary
Perceptronix Medical Inc.
Ste. 400, 555 West 8Avenue
Vancouver, Canada V5Z 1C6
Phone: (604) 707 – 9037
info@perceptronix.com
