Press Releases 21/3/20: Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic 21/3/2020: Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test 22/3/20: HHS, DoD collaborate with Cepheid on rapid diagnostics to detect coronavirus infections 10/2/2020: Cepheid Announces Development of Test for New Coronavirus Strain (2019-nCoV)
1. What are SARS-CoV-2 and COVID-19?
SARS-CoV-2 is the name of the novel coronavirus strain, short for Severe Acute Respiratory Syndrome Coronavirus 2, responsible for the current global pandemic. SARS-CoV-2 causes the disease named COVID-19.
2. What is Cepheid doing to aid in the detection of SARS-CoV-2?
Cepheid is responding to the global need with a rapid and easy to use test that enables healthcare providers to obtain a result within an hour of obtaining a patient sample. The test runs on our GeneXpert system, which has 23,000 placements worldwide, running a menu of over 20 US-IVD and CE-IVD tests. We began developing the Xpert Xpress SARS-CoV-2 test in January and have since validated its ability to detect genomic information unique to the SARS-CoV-2 virus.
3. How fast is Xpert Xpress SARS-CoV-2 test?
The test is well suited for pandemic response. Many of our GeneXpert Systems are in hospital labs and other near-patient settings. From the time a sample (such as a nasopharyngeal swab) is taken, a result can be obtained in less than an hour. We call this “sample-to-answer” and it can be achieved faster than any other test available. It takes less than a minute to prepare the cartridge with the patient sample and approximately 45 minutes for GeneXpert to determine a result after a test cartridge is loaded onto the system.
4. What is Cepheid’s regulatory plan?
Cepheid utilized the US FDA Emergency Use Authorization regulatory pathway and received authorization on March 20, 2020. Concurrently, Cepheid is working closely with other regulatory agencies to attain the relevant clearances, including CE-IVD, in order to ensure we deliver the test globally to those countries most in need.
5. When do you expect the test to be available?
Our plan is to start shipping Research Use Only (RUO) and Emergency Use Authorization (EUA) tests before the end of March.
6. How do I get a test?
Hospitals and labs currently using a GeneXpert system will be able to run the tests. It’s up to the healthcare professionals at those facilities to determine who meets the criteria for being tested.
7. How do I get a GeneXpert System at my facility?
Click the green request information button at the top of this page to be connected with your local Cepheid Sales Representative.
8. What materials are needed to run a test?
The test cartridge is a complete solution containing all the necessary reagents. A patient sample is loaded into the cartridge and a GeneXpert System is required to run the test. This is different from some other test kits on the market which may require additional reagents such as extraction materials.
9. Which GeneXpert Systems will be supported?
GeneXpert II, IV, XVI, Infinity 48, Infinity 80, and Xpress Systems.
10. What strains of coronavirus will be detected by the test?
The test is designed to detect only SARS-CoV-2.
11. Which specimen types will Cepheid’s test use?
Appropriate sample types for testing include nasopharyngeal (NP), nasal, mid-turbinate, or oropharyngeal swabs in UTM/VTM or saline, and nasal wash/aspirates in UTM/VTM or saline.^
12. Is this test CLIA Waived?
Yes, Xpert Xpress SARS-CoV-2 is authorized to be run on the GeneXpert Xpress System in point of care settings. As such, the FDA deems this to be a CLIA waived test that can be used in settings operating under a CLIA Certificate of Waiver or Certificate of Compliance. The test is also FDA authorized to be run on GeneXpert and Infinity Systems in laboratories certified under CLIA to perform high and moderate complexity tests. Please refer to the package inserts for complete details and an explanation from the FDA can be found in their FAQs.#
13. How can I get more information?
This webpage will be updated regularly with additional information as it becomes available. For questions please click the green request information button at the top of this page.