10/20/15 – ClearPrep Obtains ANVISA approval in Brazil
December 31, 2015
ClearPrep Obtains ANVISA approval in Brazil
TUSTIN, CALIFORNIA – Resolution Biomedical, Inc. announced today that its ClearPrep Next- Generation Liquid-Based Cytology products have been approved by the Brazilian Health Surveillance Agency (ANVISA), for use by medical testing laboratories throughout Brazil.
“ANVISA approval opens the door to launching ClearPrep in the largest medical market in South America, and provides an important pathway to other markets in the region,” 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.