We’ve had several posts about measuring the new oral anticoagulants, the most pressing concern for coagulation laboratories around the world as they are confronted with the need to determine the presence and levels of dabigatran, rivaroxaban, apixaban, and soon, edoxaban. Though pharmaceutical distributors reassure us there is no need for monitoring, we are confronted with patients who have renal insufficiency, who are bleeding from a possible, but undefined overdose, concerns for non-compliance, or patients with potential coagulation imbalances as are documented in cancer, liver disease, during pregnancy, obesity, small body mass, chronic DIC, or those suffering a current thrombotic episode. Especially troublesome for lab scientists are clinical efforts to screen for coagulopathies while patients are on anticoagulants, a recurring issue in which lab scientists attempt to integrate skewed results.
In vitro diagnostics (IVD) distributors are currently scrambling to meet these clinical needs, and several apparently effective assays are in development, however all are currently classified as research or investigational use only (RUO or IUO). In the past, tertiary care and reference laboratories purchased and employed RUO or IUO kits, attaching cautionary notes to the results. Knowing that third party payers may not reimburse, lab directors posted advance beneficiary notices at the time the tests were ordered or collected, warning patients and their physicians that patients may be assessed for the cost of the test, and also indicating the assay’s experimental nature.
Now, because of a June 1, 2011 FDA document, most IVD distributors prefer not to ship RUO or IUO kits in the US, rendering them unavailable except when used non-diagnostically in clinical trials. The Europace article posted here on May 9 and reposted below references the new assays, implying perhaps they are available, however US laboratory directors should be aware that they may be restricted. Here is the FDA statement:
Here is the 2013 Europace article:
I hope this is helpful, and I also hope the FDA review process for the new assays moves efficiently so we can soon meet clinical demands. Geo.