LabCorp Launches Hepatitis C Drug Resistance Tests
LabCorp has launched two new tests to determine patient sensitivity to extremely pricey drugs that treat hepatitis C. The North Carolina-based LabCorp has introduced the HCV NS5A and NS5B assays. Those tests, which use next-generation sequencing, are intended to determine how a patient would respond to a treatment regimen of sofosbuvir, ledipasvir, or a combination of the two drugs. Sofosbuvir and ledipasvir have roiled the U.S. health care and pharmaceutical sectors over the past couple of years. They can cure more than 90 percent of the cases of hepatitis C over several weeks with few side effects. Prior to the introduction of the drugs in 2013 and last year, the primary way to treat the disease was with a liver transplant. Altogether, the U.S. Food and Drug Administration has approved a half-dozen direct acting antiviral drugs for hepatitis C since 2011. About 3 million Americans have been diagnosed with hepatitis C. Prior to the introduction of the drugs, up to 5 percent of them would eventually die from chronic liver inflammation. However, a dose of the drugs in single or cocktail form can cost $90,000 or more—a price that has forced some insurers and state Medicaid and prison medical programs […]
LabCorp has launched two new tests to determine patient sensitivity to extremely pricey drugs that treat hepatitis C.
The North Carolina-based LabCorp has introduced the HCV NS5A and NS5B assays. Those tests, which use next-generation sequencing, are intended to determine how a patient would respond to a treatment regimen of sofosbuvir, ledipasvir, or a combination of the two drugs.
Sofosbuvir and ledipasvir have roiled the U.S. health care and pharmaceutical sectors over the past couple of years. They can cure more than 90 percent of the cases of hepatitis C over several weeks with few side effects. Prior to the introduction of the drugs in 2013 and last year, the primary way to treat the disease was with a liver transplant. Altogether, the U.S. Food and Drug Administration has approved a half-dozen direct acting antiviral drugs for hepatitis C since 2011.
About 3 million Americans have been diagnosed with hepatitis C. Prior to the introduction of the drugs, up to 5 percent of them would eventually die from chronic liver inflammation.
However, a dose of the drugs in single or cocktail form can cost $90,000 or more—a price that has forced some insurers and state Medicaid and prison medical programs to place caps on how much they could spend on regimens for enrollees. However, resistance to the drugs also means some patients could receive a treatment that is as expensive as it is futile. The new tests mostly eliminate that risk.
Although LabCorp would not disclose the current or potential market for the new tests, F. Samuel Eberts, the company's senior vice president of corporate affairs, said in an email that "we are very pleased with physician interest and use of our industry leading assays."
Those two tests, in addition to an assay LabCorp introduced in 2011, HCV GenoSure NS3/4A, allows the company to provide a "complete (hepatitis C) portfolio," Eberts wrote.
Takeaway: LabCorp's new assays will likely eliminate expensive and futile treatments for some sufferers of hepatitis C.
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