Press Releases

Cepheid Receives FDA Clearance and CLIA Waiver for Xpert® Xpress Flu/RSV Test

Respiratory Infection Results in as Little as 20 Minutes1

SUNNYVALE, CALIF. — July 26, 2018 —  Cepheid announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the Xpert® Xpress Flu/RSV test. The test can be performed in near-patient settings, providing rapid and accurate molecular detection of influenza A and B viruses, and RSV RNA from patient specimens in as little as 20 minutes.1

Read more ...

Cepheid announces expanded access to Xpert family of virology tests in global regions with the greatest need

SUNNYVALE, CALIF. — July 23, 2018 — Cepheid has announced that under its HBDC Access Program1, the company will immediately lower the price of Xpert® tests used for molecular diagnosis of human immunodeficiency virus (HIV), viral hepatitis (HCV) and human papilloma virus (HPV)2 to US $14.90, to make the tests more accessible to lower-income countries.

Read more ...

FDA Clears Expanded Claims for ‘Superbug’ Test

Xpert® Carba-R now FDA-cleared to aid clinicians in determining appropriate therapeutic strategy for pure colony specimens

SUNNYVALE, CALIF. — May 15, 2018 — Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for expanded claims for Xpert® Carba-R, an on-demand
molecular test for rapid and accurate detection of carbapenemase-producing Gram-negative bacteria. The additional claims extend use to analysis of perirectal swab specimens and allow use of Xpert Carba-R test results to guide therapeutic strategies for pure colonies.

Read more ...

Cepheid Receives FDA Clearance and CLIA Waiver for Xpert Xpress Strep A

Accurate and Reliable Group A Streptococcus Detection in as Little as 18 Minutes1

SUNNYVALE, CALIF. — May 2, 2018 — Cepheid announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and waiver under the Clinical Laboratory Improvement Amendments (CLIA) for the Xpert® Xpress Strep A test. The test can be performed in near-patient settings by untrained users, to provide rapid and accurate molecular detection of Streptococcus pyogenes (i.e., Group A Strep) in as little as 18 minutes.1

Read more ...

New IDSA/SHEA Guidelines Highlight Critical Role of PCR Testing in C. difficile Diagnosis

Updated guidelines reaffirm PCR as highly sensitive method for detecting deadly toxigenic C. difficile

SUNNYVALE, CALIF. — February 20, 2018 — Newly released IDSA/SHEA Clinical Practice Guidelines for C. difficile, a major cause of gastrointestinal infection, once again emphasize the need for rapid diagnosis of Clostridium difficile infection (CDI) and the critical role of polymerase chain reaction (PCR) testing methods.

Read more ...

Cepheid Receives FDA Clearance and CLIA Waiver for Xpert® Xpress Flu Test

Flu Results in as Little as 20 Minutes1

SUNNYVALE, CALIF. — January 9, 2018 — Cepheid announced today it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the Xpert® Xpress Flu test. The test can be performed in near-patient
settings, providing rapid and accurate molecular detection of Flu A and B RNA from patient specimens, in as little as 20 minutes.1

Read more ...

Cepheid Expands Respiratory Disease Portfolio with Xpert Xpress Strep A

Accurate and Reliable Group A Strep Detection in as soon as 18 minutes1

SUNNYVALE, CALIF. — October 5, 2017 — Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Xpress Strep A. The test provides rapid, accurate, and reliable molecular detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus or Strep A) DNA from patient throat specimens in as little as 18 minutes for a positive result.

Read more ...

2017 launch of new TB test Ultra backed by WHO recommendation

Xpert MTB/RIF Ultra can better diagnose TB in children and people living with HIV

Sunnyvale, CA, USA; New Brunswick, NJ, USA; Geneva, Switzerland – 24 March 2017 -- On World TB Day, Cepheid, Rutgers New Jersey Medical School and FIND today announced a new version of the Xpert MTB/RIF test, the Xpert® MTB/RIF Ultra (Ultra), for the diagnosis of TB and rifampicin resistance. The World Health Organization (WHO) earlier today issued a recommendation that Ultra can be used as an alternative to the existing Xpert MTB/RIF test for the diagnosis of TB and detection of rifampicin resistance in all settings1.

Read more ...

Cepheid Announces FDA Clearance Of Xpert® Xpress Flu And Xpert Xpress Flu/RSV

Providing Rapid Molecular Diagnostic Results in as little as 20 minutes

SUNNYVALE, Calif.Feb. 15, 2017 /PRNewswire/ -- Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Xpress Flu and Xpert Xpress Flu/RSV. Both tests deliver reference-quality molecular results in as little as twenty minutes. The tests are Cepheid's first Xpress branded products — all of which are expected to deliver results in 30 minutes or less.1

Read more ...

Cepheid Announces FDA Clearance of Next-Generation Test for MRSA Colonization

SUNNYVALE, Calif.Dec. 19, 2016 /PRNewswire/ -- Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for Xpert® MRSA NxG, the next generation methicillin-resistant Staphylococcus aureus (MRSA) infection control test from the leader in healthcare-associated infection (HAI) testing. Xpert® MRSA NxG is an accurate, on-demand, molecular test that delivers actionable results in about an hour.

Read more ...