LabCorp Attracts More FDA Attention
On September 29, LabCorp drew an FDA warning letter regarding an advanced diagnostic. This isn't the first time this has happened.
A earlier letter went to LabCorp's partner EXACT Sciences for the company's PreGen-Plus colon cancer assay. FDA determined that PreGen-Plus was being sold to LabCorp as a diagnostic. However, PreGen-Plus is still available from LabCorp, so perhaps LabCorp and EXACT were able to address FDA's concerns without receiving FDA regulatory approval.
On August 7, FDA first sent LabCorp a letter expressing concern about OvaSure, a test LabCorp developed in collaboration with Yale University for ovarian cancer. In September, FDA sent a new letter to LabCorp, revealing FDA's determination that OvaSure is "not within the scope of laboratory developed tests" which FDA declines to regulate.
The issue in both cases is a test that was developed in one lab, then practiced in another lab. Under CLIA regs, Labs may practice some tests that they develop themselves. FDA has the authority to regulate such tests, but chooses not to regulate tests that are developed and practiced in the same lab. FDA does, however, assert its authority to regulate tests developed in one lab and practiced in another.
FDA determined that this is the case with OvaSure. The FDA letter states that "OvaSure™ is a test that was designed, developed, and validated by investigators at Yale University and not LabCorp. Instructions for use and performance characteristics appear to have been developed by Yale investigators."
Dr. Alberto Gutierrez, who is Deputy Director of the FDA office responsible for evaluating in vitro diagnostics, will be at the upcoming Burrill Personalized Medicine Meeting. The discussion seems likely to include this case, or at least the issue of homebrew tests in this situation.
A earlier letter went to LabCorp's partner EXACT Sciences for the company's PreGen-Plus colon cancer assay. FDA determined that PreGen-Plus was being sold to LabCorp as a diagnostic. However, PreGen-Plus is still available from LabCorp, so perhaps LabCorp and EXACT were able to address FDA's concerns without receiving FDA regulatory approval.
On August 7, FDA first sent LabCorp a letter expressing concern about OvaSure, a test LabCorp developed in collaboration with Yale University for ovarian cancer. In September, FDA sent a new letter to LabCorp, revealing FDA's determination that OvaSure is "not within the scope of laboratory developed tests" which FDA declines to regulate.
The issue in both cases is a test that was developed in one lab, then practiced in another lab. Under CLIA regs, Labs may practice some tests that they develop themselves. FDA has the authority to regulate such tests, but chooses not to regulate tests that are developed and practiced in the same lab. FDA does, however, assert its authority to regulate tests developed in one lab and practiced in another.
FDA determined that this is the case with OvaSure. The FDA letter states that "OvaSure™ is a test that was designed, developed, and validated by investigators at Yale University and not LabCorp. Instructions for use and performance characteristics appear to have been developed by Yale investigators."
Dr. Alberto Gutierrez, who is Deputy Director of the FDA office responsible for evaluating in vitro diagnostics, will be at the upcoming Burrill Personalized Medicine Meeting. The discussion seems likely to include this case, or at least the issue of homebrew tests in this situation.
Labels: diagnostics, FDA
