New HCV Test Enables Diagnosis and Treatment in a Single Visit

The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV).

The FDA reviewed the Xpert HCV test and GeneXpert Xpress System under its De Novo premarket review pathway, establishing special controls to ensure safety and effectiveness.

The Xpert HCV test is designed for use in point-of-care settings, including substance use disorder treatment facilities, correctional facilities, syringe service programs, doctor’s offices, emergency departments and urgent care clinics. Unlike traditional testing methods that require samples to be sent to central laboratories, this test utilizes a blood sample from the fingertip to detect HCV RNA, delivering results in approximately one hour.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), emphasized the potential impact of this test, stating, “Equipping healthcare providers with tools to diagnose and treat patients in the same visit can result in hundreds of thousands more hepatitis C patients being diagnosed and treated, preventing individual disease progression and additional spread of the virus.”

The Xpert HCV test’s development was validated through the Independent Test Assessment Program (ITAP), part of the National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program. Bruce J. Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), highlighted the importance of this collaboration, stating, “Today’s announcement by the FDA of marketing authorization for a rapid diagnostic to detect hepatitis C RNA is an example of the power of the RADx Tech model to deliver a much-needed test to millions of people in record time.”

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The Need for a Hepatitis C Test

HCV is a bloodborne virus causing acute and chronic liver inflammation, from mild illness to severe conditions like cirrhosis and liver cancer. It is mainly transmitted through infected blood via unsafe injections, inadequate sterilization, unscreened transfusions and drug use and less commonly through sexual practices involving blood exposure.

Hepatitis C affects an estimated 50 million people globally, with about one million new infections each year, according to the World Health Organization (WHO). The infection, if left untreated, can lead to severe health issues such as liver cancer and liver failure. In 2022 alone, hepatitis C contributed to approximately 242,000 deaths, primarily from cirrhosis and hepatocellular carcinoma (primary liver cancer).

The US Centers for Disease Control and Prevention’s (CDC) Yellow Book 2024 states HCV is a major cause of cirrhosis and liver cancer and the leading reason for liver transplants in the US. About 80 percent of acute cases are asymptomatic. Without treatment, over half become chronically infected, with 10 to 20 percent developing cirrhosis over 20 to 30 years.

Globally, an estimated 62 million people had HCV in 2019, with higher rates in Eastern Europe, Africa, the Middle East and Central Asia. Most transmission occurs through sharing drug preparation and injection equipment, with unsafe medical procedures also playing a significant role.

The traditional HCV testing process involves multiple steps, often requiring follow-up appointments that can lead to patients not receiving a timely diagnosis and necessary treatment. “Despite the existence of a safe and highly effective oral cure for hepatitis C [such as Abbvie’s Mavyret (glecaprevir/pibrentasvir) and Gilead’s Epclusa (sofosbuvir/velpatasvir) for chronic hepatitis C], many people do not know they have the disease due partly to the lack of availability of convenient, widespread testing options,” added Shuren in the FDA news release.

The Xpert HCV test addresses this issue by enabling a test-and-treat approach, where patients can be tested and potentially receive treatment in a single healthcare visit.

About the Xpert HCV Test

Cepheid’s Xpert HCV test is the first molecular test in the US to detect HCV RNA directly from a human capillary whole blood (fingerstick) sample. “This simple-to-use test detects the full range of known HCV genotypes in about an hour and can be performed on a small volume of blood collected via fingerstick,” said Dr. David H. Persing, Cepheid’s chief medical and scientific officer in Cepheid’s press release.

The Xpert HCV test is performed on the GeneXpert Xpress System, which offers fully automated sample extraction and detection. Additionally, the test delivers results in about an hour and accurately detects active HCV infection from individuals at risk, or those with signs and symptoms of HCV infection, regardless of the presence of HCV antibodies.

“This is the first HCV RNA detection technology sensitive enough for active case finding at the point of care. This enables diagnosis of HCV and facilitates timely linkage to care within a single clinic visit — and with this, the potential for treating more people with HCV,” added Cepheid’s president, Vitor Rocha.

The Xpert HCV test is for adults showing signs or at risk of hepatitis C but is not for monitoring patients in treatment or screening donors, where there could be risks of false positives and negatives, potentially leading to inappropriate or delayed treatment.

Related: Abbott’s HPV Test Gets FDA Approval for High-Risk HPV Detection and Cervical Cancer Screening

Hepatitis C Drug Market Trends

The global hepatitis C drug market was valued at $7.86 billion in 2018 and is projected to reach  $9.84 billion by 2032, growing at a compound annual growth rate (CAGR) of 1.8 percent. North America dominated the market in 2018 with a 47.46 percent share. Key players in the market include Gilead Sciences, AbbVie, Merck, Bristol-Myers Squibb, Janssen Pharmaceuticals, F. Hoffmann-La Roche and Vertex Pharmaceuticals.

The hepatitis C drug market’s growth is segmented into NS5A inhibitors (protease inhibitors), fixed-dose combinations and others, driven primarily by fixed-dose combination drugs, which are effective across all HCV genotypes and offer shorter treatment durations. Chronic hepatitis C represents the primary market segment.

Hepatitis C Testing and Treatment

Direct-acting antiviral (DAA) medicines are the current standard of care for hepatitis C treatment. They target HCV directly, disrupting viral growth and replication. DAA treatment is short (12 to 24 weeks) and can cure most people with hepatitis C infection.

The WHO recommends testing people at increased risk of infection and providing access to testing, prevention, care and treatment services. However, despite the availability of effective treatments, access remains limited. A report by the CDC revealed that Medicaid and Medicare recipients were significantly less likely to receive timely DAA treatment compared to those with private insurance. The study added that despite reduced costs for DAAs, preauthorization requirements and integrating hepatitis C screening and treatment into primary care hinder access to treatment.

In 2022, only 36 percent of the estimated 50 million people living with HCV globally knew their diagnosis, and only 20 percent of those diagnosed had been treated with DAAs.

The authorization of the Xpert HCV test and GeneXpert Xpress System is a significant step forward in the fight against hepatitis C.

The approval aligns with the goals outlined in the US Department of Health and Human Services’ (HHS) Viral Hepatitis National Strategic Plan: A Roadmap to Elimination 2021-2025, and the WHO’s strategy to eliminate AIDS, viral hepatitis and sexually transmitted diseases by 2030. This plan envisions a future where new viral hepatitis infections are prevented, every person knows their status, and those with viral hepatitis receive high-quality care without stigma or discrimination. The most recent data (2021) taken from the HHS website attributes 3.18 deaths — the target being 1.44 — per 100,000 people with hepatitis C as the underlying or contributing cause.

By making testing more accessible and immediate, the new molecular diagnostic test has the potential to significantly reduce the burden of hepatitis C, improving health outcomes and preventing the spread of the virus.

On World Hepatitis Day, observed annually on July 28, global health organizations will emphasize the importance of expanding access to hepatitis testing and treatment. The theme of this year’s World Hepatitis Day, “It’s time for action,” underscores the urgent need to bring hepatitis prevention and treatment services closer to communities to save lives and achieve hepatitis elimination goals by 2030.