A company called Laboratory Corporation, part of American Holdings, recently sent out a press release announcing their marketing of HCV Fibrosure. The press release touts Fibrosure as a non-invasive alternative to liver biopsies for measuring fibrosis and necroinflammatory activity using a blood test.
Fibrosure has been used extensively in France over the last couple of years, where it was developed by a leading French hepatologist, Thierry Poynard, and colleagues. The test is marketed in France as 'FibroTest' by BioPredictive.
Liver biopsies carry a small risk of complications (internal bleeding) and many people with hepatitis C are reluctant to undergo the procedure. There can be pain involved; drug users in particular may legitimately fear that they won't get adequate pain medication. In addition, liver biopsies are contraindicated for some people (for example, people with low platelet counts). For these reasons, a non-invasive alternative to biopsy would be welcome, and constitutes something of a holy grail in hepatitis C care.
FibroTest appears relatively good at gauging both 1) very early or minimal and 2) relatively advanced liver disease, though it doesn't perform as well for people in the middle of the spectrum. One independent evaluation comparing FibroTest to biopsy results concluded that "the FibroTest score could not accurately predict the presence or absence of significant liver fibrosis." The complete study, from the journal Clinical Chemistry, is available here.
A recent review of the role of liver biopsy and noninvasive markers of fibrosis, written by Duke University's John McHutchison for a CME program by Project in Knowledge, is available here.
It's not clear yet how much Fibrosure will cost, and whether Medicaid and private insurers will reimburse for the test.
In a future post, I'll report on what American doctors are saying about Fibrosure.