RICHMOND, BC, June 27 /PRNewswire/ - bioLytical(TM) Laboratories announced today, that their INSTI(TM) kit, a rapid HIV antibody test developed by the company, received CE Mark approval in their European Community.
“We are delighted to have received CE Mark approval for INSTI”, says Robert Mackie, President and CEO. To have CE Mark approval will now allow us to enter the European market and target 28 different countries.”
INSTI is the only test approved by Health Canada for Point of Care testing and is one of four tests approved in the European Union. With the strictest accreditation behind the INSTI kit, these milestones are a true verification of INSTI’s quality and accuracy.
The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives. The letters ‘CE’ are an abbreviation of Conformite Europeenne, French for European conformity.
INSTI(TM) is a highly effective and reliable rapid HIV test that detects the presence of antibodies to HIV in whole blood, serum or plasma in 60 seconds. It has a 99.96% accuracy rate, as demonstrated in extensive clinical trials carried out in multiple centers across Canada. To further ensure INSTI(TM) maintains its high quality, it is manufactured in Canada under strict controls in a state-of-the-art ISO accredited facility. INSTI has gone through extensive clinical trials and is the only HIV kit approved by Health Canada for Point of care testing. They are also registered in Uganda, Kenya, and Vietnam.
bioLytical(TM) Laboratories (Inc.) is a leading developer and manufacturer of diagnostic tests for global health care markets. The company produces the highly accurate and reliable INSTI(TM) kit; the only rapid HIV test kit approved by Health Canada for use in a point of care setting, such as a doctor’s office or hospital. bioLytical(TM) is a privately owned company with headquarters and state of the art manufacturing facility located in Richmond, British Columbia with an office in United Kingdom and Uganda, Africa. For more information about bioLytical and INSTI(TM), please visit www.biolytical.com.
Media Contact: Debbie Collins bioLytical(TM) Laboratories Telephone: (604) 204-6784 ext. 236 Cell: 604 716-7934 Email: dcollins@biolytical.com
bioLytical Laboratories
CONTACT: Media: Debbie Collins, bioLytical(TM) Laboratories, Telephone:(604) 204-6784 ext. 236, Cell: (604) 716-7934, Email:dcollins@biolytical.com