Can someone please educate me on the PCSK9 testing Atherotech is marketing to physicians? Is there any clinical data behind the testing and has the testing been validated by the FDA or any other government regulatory body?
Can someone please educate me on the PCSK9 testing Atherotech is marketing to physicians? Is there any clinical data behind the testing and has the testing been validated by the FDA or any other government regulatory body?
The PCSK9 assay is looking at PCSK9 levels. It is not relevant to measure PCSK9 activity pre or post therapy with PCSK9. The reference range is very broad, therefore there is no therapeutic index that it relates to.
There are studies looking at levels but there is no benefit. Low prognostic utility of measuring PCSK9 levels in ACS
In patients with an acute coronary syndrome (ACS), a high circulating level of proprotein convertase subtilisin kexin 9 (PCSK9) is associated with the presence of familial hypercholesterolaemia, use of lipid-lowering therapy, and presence of inflammation; however, the PCSK9 level does not provide prognostic information about 30-day or 1-year mortality.
no it won't.
For a test to be covered there has to be sound analytical validation( meaning the method used to perform the test is sound and reproducible, that the samples don't vary significantly from one to another)
Second clinical utility: prefer outcomes studies proving that the test has impact on clinical decision making and is actionable ( there is a treatment that makes a difference)
Third: is cost effective.
This test by Atherotech fails on all three.
The test kit used is listed for "research purposes only"
Thanks! but why would my doctor order this? Why would the lab run a test they don't get paid for? Just wondering how they make money on a test that gets no reimbursement.
Thanks! but why would my doctor order this? Why would the lab run a test they don't get paid for? Just wondering how they make money on a test that gets no reimbursement.
Pretty sure a commercial insurance company wouldn't cover the cost of the test but I wonder if the company bills Medicare/Medicaid and does get reimbursed? Sounds kind of fishy to me if they are getting reimbursed by the government for a test that hasn't been proven...IMHO.
