FDA to Review Two Roche Genotyping Tests That Detect, Strain-Type HPV
Roche Diagnostics said this week that the US Food and Drug Administration will review for clearance a pair of its genotyping-based tests that detect and strain-type human papillomavirus.
According to Roche, the first test, called Amplicor HPV, will detect 13 high-risk HPV genotypes from clinical samples, while the other test, the Linear Array, will identify “which of those 13 types are in a particular sample.
Daniel O’Day, head of Roche Molecular Diagnostics, said HPV tests could help doctors “identify and manage persistent, high-risk HPV infections before they progress to more serious forms of the disease.”
Recent studies have shown that women infected with HPV are at increased risk for developing cervical cancer.
SensiGen Exercise Option to HPV Test Developed By University of Michigan
SensiGen announced this week that it has exercised its option to exclusively license Human Papillomavirus detection test, called the AttoSense HPV Test, developed at the University of Michigan.
The technology has demonstrated the ability to detect one to three copies of HPV DNA in any blood or tissue sample, and to identify in a single assay each of the 15 unique genotypes of HPV that cause cervical cancer in women.
“Clinically, our research has shown that this assay can virtually eliminate errors, in terms of false negative or false positive results, commonly associated with current testing methods,” said David Kurnit, professor of pediatrics and communicable diseases at the University of Michigan Medical Center, whose lab developed the test.
XDx Licenses U. of Minnesota IP to Develop Lupus Dx
XDx will in-license IP from the University of Minnesota that will enable the company to use gene expression technology to assess the status of systemic lupus erythematosus in patients, it said last week.
XDx also said it has entered a separate agreement with UM and the Feinstein Institute for Medical Research in New York that gives the company access to SLE patient samples taken from an NIH-funded study of biomarkers for autoimmune diseases.
The company plans to use these samples to in its work to develop lupus diagnostics.
Financial terms of the agreement were not released.