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Tag Archives: Cepheid—

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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CE mark for bladder cancer recurrence test

Oct. 18, 2016—Cepheid has launched a test designed to rule out bladder cancer recurrence, the Xpert Bladder Cancer Monitor, in Germany and announced that it has been cleared for commercial availability in all countries accepting the CE mark. The test is designed to provide up-to-date information on cancer recurrence for bladder cancer patients, using a noninvasive urine specimen. The test has an ...

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Cepheid at work on fingerstick HIV viral load assay

Oct. 13, 2016—Cepheid is working to develop a test to deliver lab-quality results from a few drops of fingerstick-collected blood at remote patient sites. Patients today in resource-limited settings can wait weeks to months for important HIV viral load test results that could support better antiretroviral therapy management. Cepheid’s Xpert Finger Stick HIV-1 Viral Load Assay builds on the company’s ...

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Cepheid’s Xpert TV cleared for testing men

Oct. 7, 2016—The Food and Drug Administration has allowed expanded claims for Cepheid‘s Xpert TV assay, a urine-based test for Trichomonas vaginalis that delivers results in as little as 35 minutes. Trichomoniasis is considered to be the most common nonviral sexually transmitted infection in the U.S., infecting an estimated 1.4 million men. Trich is particularly challenging because as many as ...

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Danaher buys Cepheid for $4 billion

Sept. 6, 2016—Danaher has entered into a definitive merger agreement with Cepheid pursuant to which Danaher will acquire all of the outstanding shares of Cepheid for $53 per share in cash, or a total enterprise value of about $4 billion including indebtedness and net of acquired cash. “We expect Cepheid to be an excellent complement to our existing diagnostics businesses ...

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Cepheid’s sample-to-susceptibility CRE test cleared

Aug. 30, 2016—The Food and Drug Administration cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to carbapenem antibiotics. “By using a specimen taken directly from a patient to test for the presence of genetic markers, hospitals can more quickly identify these dangerous ...

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CLIA waiver for Cepheid’s POC flu/RSV test

Dec. 14, 2015—The Food and Drug Administration has granted 510(k) clearance and a Clinical Laboratory Improvement Amendments waiver for Cepheid‘s Xpert Flu+RSV Xpress test for use on the GeneXpert Xpress System. The system is composed of a single module and a tablet computer with an ATM-like interface specifically for the CLIA waived environment. Xpert Flu+RSV Xpress is the first PCR ...

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FDA clears Cepheid’s trichomoniasis test

Oct. 23, 2015—Cepheid has received clearance from the FDA to market Xpert TV, a qualitative in vitro diagnostic test for accurate and reproducible identification of trichomoniasis in symptomatic and asymptomatic female patients, using urine, endocervical swab, or vaginal swabs collected by the patient in a clinical setting. Xpert TV is the 18th test available to run on Cepheid’s GeneXpert System ...

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