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PreventionGenetics Receives FDA Approval for its Companion Diagnostic Genetic Test as a Class II Medical Device
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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.
We recently released an option for our pre-defined panels to be run on a PGnome® (genome) sequencing backbone. But you may be wondering … what’s a backbone?
Inherited kidney diseases have an overall prevalence of ~6-8 in 10,000 births in the United States and Europe, and accounts for up to 37% of adults with renal diseases (Cocchi et al. 2020. PubMed ID: 32646915; Connaughton et al. 2019. PubMed ID: 30773290; Lata et al. 2018. PubMed ID: 29204651). Obtaining an early diagnosis for kidney disease is important for establishing optimal maintenance and treatment plans for patients and their families, which is why genetic testing has been increasingly integrated into clinical practice.
PreventionGenetics selected to join Concert Genetics’ Preferred Laboratory Network
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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.
Introducing PGnomeⓇ - Whole Genome Sequencing from PreventionGenetics
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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.
