PreventionGenetics Receives FDA Approval for its Companion Diagnostic Genetic Test as a Class II Medical Device
PreventionGenetics, a subsidiary of Exact Sciences Corp., announced today that it was recently granted marketing authorization for the POMC/PCSK1/LEPR companion diagnostic (CDx) genetic test as a Class II device by the Center for Devices and Radiological Health (CDRH), a division of the Food and Drug Administration (FDA). Developed in collaboration with Rhythm Pharmaceuticals, Inc., the test is the first FDA-authorized Class II molecular companion diagnostic device.
Early detection and diagnosis of Congenital Heart Defects (CHDs) is essential to guide patient care. Survival and medical care for children with CHDs are improving. Among states with mandatory CHD screening via pulse oximetry, a 33.4% reduction of early infant deaths due to CHD was observed (Abouk et al., 2017). Initial diagnosis is only the beginning. Genetic testing for CHD also plays an important role in improving outcomes.
PreventionGenetics selected to join Concert Genetics’ Preferred Laboratory Network
MARSHFIELD, Wis. –With more than 150,000 genetic tests available, at least 6.9 codes per claim and thousands of medical policies1,2, it’s virtually impossible for providers and payers to keep up with the complex and ever-changing world of genetic testing. Today, PreventionGenetics joins Concert Genetics’ Preferred Laboratory Network, which brings health plans and preferred laboratories together to ensure that the quality, pricing and service information needed for decision-making is at the forefront and eases the administrative burden involved in insurance claims processing for genetic testing.
Dr. James Weber, PhD, Receives Wisconsin Biohealth Business Achievement Award
Marshfield, WI - Dr. James Weber PhD, President and Founder of PreventionGenetics, has been named the 2020 recipient of the Wisconsin Biohealth Business Achievement Award. The annual award recognizes leaders in Wisconsin for their achievements in the biohealth and life science industry.
Introducing PGnomeⓇ - Whole Genome Sequencing from PreventionGenetics
Marshfield, WI - PreventionGenetics is excited to announce the availability of their new whole genome sequencing (WGS) test, PGnome®. Prices start at only $2,490 for testing of a single patient. WGS is the ultimate germline DNA test. It is superior to exome and other genetic tests because it covers the entire genome, including deep intronic regions. WGS yields better detection of structural variants (deletions, duplications, inversion and translocations of DNA sequence) and improved analysis of tandem repeats and paralogous regions. Furthermore, WGS is essential for assessing disease risk and prevention using polygenic risk algorithms.