Cepheid 的 Xpert 出血热多重 PCR 检测获 FDA 许可

New multiplex PCR test simultaneously detects Ebola, Marburg, Lassa and Crimean-Congo hemorrhagic fever viruses in approximately 61 minutes.

, /PRNewswire/ -- Cepheid, a Danaher operating company, today announced that the U.S. Food and Drug Administration (FDA) has cleared Xpert Hemorrhagic Fever Panel, a multiplex PCR test designed for the qualitative detection and identification of RNA from viruses that cause several viral hemorrhagic fevers from a single sample.

Xpert Hemorrhagic Fever Panel detects and identifies nucleic acids of the following viruses: Ebola virus (including Zaire, Sudan, Taï Forest, and Bundibugyo, not differentiated), as well as Marburg virus, Lassa virus, and Crimean-Congo hemorrhagic fever (CCHF) virus.

Xpert Hemorrhagic Fever Panel delivers results in approximately 61 minutes on Cepheid's GeneXpert® Dx systems. Its closed-cartridge design minimizes the risk of cross-contamination between samples, and the sample processing step includes viral inactivation to support safe laboratory workflows.

The global need remains significant. Ebola disease caused by Bundibugyo virus (BDBV) continues to spread geographically in the Democratic Republic of the Congo, Kenya, and Nigeria. As of October 31, 2026, there are 10,351 confirmed cases and 5,026 deaths reported.¹ Lassa fever is estimated to cause 100,000–300,000 infections and approximately 5,000 deaths annually in West Africa^2,3 while Marburg virus and Crimean-Congo hemorrhagic fever (CCHF) are estimated to cause 10,000-15,000 human infections annually.^2-4 

Importantly, early symptoms of Ebola, Marburg, Lassa, and CCHF are often non-specific and difficult to distinguish from other febrile illnesses.⁷ Therefore, rapid detection can support timely patient isolation, infection prevention measures, and public health notification.^7,8

"When patients present symptoms that could signal a viral hemorrhagic fever, every hour matters to the patient and everyone around them," said Connie Savor, Chief Medical Officer, Cepheid, a Danaher company. "Xpert Hemorrhagic Fever Panel gives healthcare professionals a rapid molecular result across several high-consequence viruses from a single sample. This FDA clearance advances our commitment to making critical diagnostics accessible where and when they are needed. By accelerating ideas to impact, we're helping provide healthcare and public health teams with timely diagnostic information to support decision-making."

In September 2026, Cepheid received World Health Organization Emergency Use Listing for the Xpert Hemorrhagic Fever Panel test, enabling Cepheid to expand its work with public health partners, laboratories, and healthcare providers to improve diagnostic access in response to the Ebola Bundibugyo (BDBV) outbreak. FDA clearance further expands the role the GeneXpert platform can play in preparedness and response to emerging infectious disease threats.

IVD. In Vitro Diagnostic Medical Device. Not available in all countries.

Reference

1. Associated Press. Congo's Ebola deaths top 5,000 as worries of continent-wide spread mounts. AP News. Updated October 31, 2026.
2. WHO. Lassa Fever Fact Sheet. https://www.who.int/news-room/fact-sheets/detail/lassa-fever [ijprems.com]
3. CDC. Lassa Fever Fact Sheet. https://stacks.cdc.gov/view/cdc/12236/cdc_12236_DS1.pdf [cdc.gov]
4. CDC. History of Marburg Outbreaks. Updated 2025. [cdc.gov]
5. World Health Organization. Crimean-Congo hemorrhagic fever: Fact Sheet. Updated February 20, 2025. [who.int]
6. UK Health Security Agency. Crimean-Congo hemorrhagic fever: origins, reservoirs, transmission and guidelines. Updated 2025. [gov.uk]
7. CDC. Screening and Evaluating an Ill Person for Viral Hemorrhagic Fevers. https://www.cdc.gov/viral-hemorrhagic-fevers/hcp/diagnosis-testing/index.html
8. CDC. Infection Prevention and Control for Patients with Suspected or Confirmed Viral Hemorrhagic Fevers. https://www.cdc.gov/viral-hemorrhagic-fevers/hcp/infection-control/index.html [ecdc.europa.eu]
9. World Health Organization. Marburg virus disease - Equatorial Guinea and the United Republic of Tanzania. Disease Outbreak News, May 8, 2023. [who.int]

About Cepheid
Cepheid, a Danaher company and a leader in molecular diagnostics, is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. Cepheid's GeneXpert^® systems and Xpert^® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid's broad test portfolio spans respiratory infections, blood virology, women's and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology, and human genetics. The company's solutions deliver actionable results where they are needed most—from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

About Danaher
Danaher is a leading global life sciences, diagnostics and biotechnology innovator committed to advancing the power of science and technology to improve human health. Through a connected ecosystem of industry-leading businesses, the Company works closely with customers to solve many of their most complex scientific challenges by accelerating discovery, development and the delivery of life-changing therapies. Powered by the Danaher Business System and 60,000 associates worldwide, the Company strives for continuous improvement, operational excellence and Innovation at the Speed of Life. Explore more at www.danaher.com.

For Cepheid Media Inquiries:
media.communications@cepheid.com

SOURCE Cepheid