The FDA has approved the first quick test for hepatitis C virus (HCV). It detects HCV RNA and helps diagnose people showing signs of hepatitis C. Healthcare providers can use it in places like doctors’ offices and urgent care centers, avoiding the need to send samples to distant labs.
The new test can deliver results within an hour using a fingertip blood sample, enabling healthcare providers to diagnose and discuss treatment options or refer patients to care during the same visit.
This is a significant improvement from previous practices where the testing process required multiple steps and visits, potentially leading to loss of follow-up and missed diagnoses.
Jeff Shuren, MD, JD, of the FDA’s Center for Devices and Radiological Health, emphasized that providing healthcare providers with tools to diagnose and treat patients on the same visit could greatly increase the number of patients diagnosed and treated for hepatitis C.
Despite the availability of effective direct-acting antivirals for HCV over the past decade, cure rates in the U.S. remain low, with as many as 4 million people affected by the virus.
The CDC’s 2020 recommendation that all adults be screened for HCV at least once, and pregnant women during each pregnancy, highlights the need for improved testing methods. The current multistep process for HCV testing often results in patients not receiving a timely diagnosis or treatment, contributing to the spread and progression of the virus.
Chronic HCV infection can lead to severe health complications such as liver cancer or liver failure if untreated. In 2022, hepatitis C was linked to over 12,000 deaths.
Symptoms of HCV infection can range from jaundice and poor appetite to nausea, stomach pain, and fatigue. Jonathan Mermin, MD, MPH, of the CDC, noted the significance of the new test in potentially curing more people, provided it is affordable and accessible.
The FDA specified that the test is not intended to monitor patients undergoing HCV treatment or to screen blood or tissue donors. There are risks associated with the test, such as false-positive or false-negative results, which could lead to unnecessary anxiety or delays in treatment.
However, the rapid and accessible nature of the test represents a hopeful advancement in the diagnosis and management of hepatitis C, aiming to reduce the disease’s impact and spread.
