10/26/15 – ClearPrep Obtains TGA approval in Australia
January 1, 2016
ClearPrep Obtains TGA approval in Australia
Australian approval also opens the door in New Zealand.
TUSTIN, CALIFORNIA – ClearPrep Next-Generation Liquid-Based Cytology has been approved by the
Therapeutic Goods Administration (TGA), for use by medical testing laboratories throughout Australia. TGA approval is also recognized by New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe). The approval for the ClearPrep Collection Vial was issued on October 20, 2015, followed by approval for the ClearPrep Laboratory Pack on October 26.
“TGA is recognized as an important regional authority, and their approval opens doors to launching ClearPrep in myriad medical markets throughout Southeast Asia,” stated Michael Friedl, CEO of Resolution Biomedical.
In addition to being registered with the US FDA & CE Marked, ClearPrep has been validated for all types of cytology, which is used to test for certain types of cancer, including cervical, oral, bladder, thyroid, among others. ClearPrep has also been validated on leading molecular-based HPV/STI testing platforms. ClearPrep features a unique patented collection vial that improves patient outcomes by increasing cellularity of samples at the point of collection.
Resolution Biomedical was founded in 2009 to develop and launch ClearPrep Next-Generation Liquid-Based Cytology. ClearPrep is used by medical testing laboratories for preparation of samples for screening of several types of cancer. It is currently available in the United States and multiple countries around the world. The company is licensed by the California Department of Public Health, is ISO 13485 certified and its facility has been registered with the US FDA.