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Tag Archives: Cepheid

Cepheid receives EUA for its SARS-CoV-2 test

March 23, 2020—Cepheid received emergency use authorization from the FDA for its Xpert Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2. The test is for use on the automated GeneXpert systems, with a detection time of about 45 minutes.

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FDA clears Xpert BCR-ABL Ultra

Oct. 7, 2019—Cepheid received clearance from the FDA for Xpert BCR-ABL Ultra for monitoring disease burden in patients with chronic myeloid leukemia. It is the first FDA-cleared test of its kind capable of delivering accurate molecular results from whole blood samples in under three hours, Cepheid said in an Oct. 2 release.

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FDA OKs diagnostic tests for extragenital testing for CT/NG

June 5, 2019—Two diagnostic tests for extragenital testing for chlamydia and gonorrhea have received 510(k) clearance by the U.S. Food and Drug Administration. The Aptima Combo 2 Assay (Hologic) and the Xpert CT/NG (Cepheid) are the first devices cleared for detecting the presence of Chlamydia trachomatisand Neisseria gonorrhoeaevia the throat and rectum. These tests were previously only cleared for testing urine, vaginal, and endocervical samples.  

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Distribution partnership for SpeeDx, Cepheid, 7/17

July 2017—SpeeDx announced an agreement with Cepheid for distribution of its PlexPCR and ResistancePlus molecular diagnostic products in key markets throughout Europe. The agreement, covering Germany, France, Italy, and the U.K., will increase coverage for the ResistancePlus MG test, a CE-IVD test for the sexually transmitted infection Mycoplasma genitalium that combines detection with testing for azithromycin resistance.

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Molecular flu tests cleared, 5/17

May 2017—Cepheid received FDA clearance to market Xpert Xpress Flu and Xpert Xpress Flu/RSV. Both tests deliver reference-quality molecular results in as little as 20 minutes. The tests are Cepheid’s first Xpress branded products, which are expected to deliver results in 30 minutes or less.

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Tuberculosis test, 9/13

Cepheid has received FDA market authorization for its Xpert MTB/RIF test, which provides results in about two hours. The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be downclassified and brought to market. Xpert MTB/RIF is for the rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA and, in specimens ...

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MRSA/SA test, 7/13:104

Cepheid has received FDA clearance to market its Xpert MRSA/SA blood culture test, which runs on its GeneXpert system, for the detection of methicillin-resistant Staphylococcus aureus and S. aureus in blood culture bottles showing gram-positive cocci in clusters in about one hour. Cepheid’s updated Xpert MRSA/SA BC test processes positive blood culture specimens to determine whether a patient’s blood is infected ...

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