News & Events:

April 11, 2008 - HiFi^® DNA Tech filed a Memorandum in Opposition in U.S. Federal District Court against FDA's Motion to dismiss the lawsuit asking the high court to overturn the HPV DNA PCR Denial Order. See also Press Release.

January 22, 2008 - HiFi^® DNA Tech filed a suit against the FDA in U.S. Federal District Court requesting the high court to overturn the FDA denial order on January 11, 2008 and the amended complaint was filed on January 22, 2008. See also Press Release.

December 14, 2007 - FDA issued an order denying the petition for down classification of HPV DNA tests to class II.

October 29, 2007 - HiFi^® DNA Tech Urges FDA to Institute DNA Sequencing as Standard Validation for Human Papillomavirus (HPV) Genotyping. The letter is posted on the FDA Dockets Management website listed under docket no. 2007P-0210, LET1.

October 15, 2007 - A lawsuit was filed by HiFi^® DNA Tech on Oct. 12 in U.S. District Court against the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) related to reclassification of HPV DNA tests from class III to class II devices.

July 2007 - Using the HiFi^® DNA LoTemp™ PCR reagents, Milford Medical Laboratory, a CLIA certified high complexity clinical laboratory, offers the nation’s first HPV genotyping and no-false positive Neisseria gonorhoeae and Chlamydia trachomatis DNA amplification tests by PCR/DNA sequencing on liquid-based cervicovaginal specimens.

June 4, 2007 - Based on HiFi^® DNA LoTemp™ PCR technology, Milford Hospital Department of Pathology published a report entitled “Routine human papillomavirus genotyping by DNA sequencing in community hospital laboratories.”

March 7, 2007 - HiFi^® DNA Tech petitioned the FDA to reclassify HPV DNA tests as class II virology test devices. The petition is published on the FDA Dockets Management website under docket no. 2007P-0210.