Inova Translational Medicine Institute
Heart Transplant Cell-Free DNA Test Enables Earlier Detection of Acute Rejection Than Biopsy
The researchers hope that donor-derived cell-free DNA testing to monitor rejection can help relieve racial disparities in heart transplant outcomes.
Inova Decides to End PGx Test Offerings in Response to FDA Warning Letter
How labs — including those that are part of other healthcare systems — offering PGx testing will react to Inova's decision to not engage with the FDA remains to be seen.
FDA Warning Letter to Inova Raises Questions About Agency Overreach Into Practice of Medicine
Pharmacogenetics and legal experts took particular issue with the agency's suggestion that "established" drug/gene relationships are found only in FDA-approved drug labels.
FDA Warns Inova to Stop Performing MediMap Tests Without Proper Regulatory Approvals
The agency said the MediMap tests are in violation of Federal Food, Drug, and Cosmetic Act because they are intended, in part, for use in disease diagnosis.
Following Newborn Pharmacogenomics Program, Inova Launches PGx Testing for Adults
Inova plans to offer broad and condition-specific PGx gene panels in its specialty clinics and is negotiating with payors for reimbursement.