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Tag Archives: Diasorin Molecular

FDA clears DiaSorin Simplexa COVID-19 test

October 2022—DiaSorin received 510(k) clearance from the FDA for its Simplexa COVID-19 Direct kit. The sample-to-answer test detects SARS-CoV-2 directly from nasopharyngeal or nasal swab specimens and is designed for use on the Liaison MDX system. The test targets two regions of the viral genome and results are available in a little over an hour.

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Simplexa COVID-19, flu A/B assay gets CE mark

November 2021—DiaSorin Molecular announced that it has CE marked its Simplexa COVID-19 and Flu A/B Direct kit. The multiplex test allows for the in vitro qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B from a patient sample in one reaction well. The assay is designed for use on the Liaison MDX and is run directly from nasopharyngeal swabs without the need for off-board extraction.

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DiaSorin releases Simplexa SARS-CoV-2 Variants Direct assay

July 2021—DiaSorin Molecular has released the Simplexa SARS-CoV-2 Variants Direct assay, for research use only, to enable detection and discrimination of four SARS-CoV-2 mutations associated with circulating virus variants without requiring upfront RNA extraction. The assay allows for the in vitro qualitative differential detection of the mutations N501Y, E484K, E484Q, and L452R from nasopharyngeal and nasal swab specimens from individuals previously diagnosed with COVID-19. These mutations are present in potential variants of clinical interest including those that were isolated in the U.K. (B.1.1.7), South Africa (B.1.351), Brazil and Japan (P.1 and P.2), New York (B.1.526/B.1.526.1), California (B.1.427/B.1.429), Nigeria (B.1.525), and India (B.1.617/B.1.617.1/ B.1.617.2/B.1.617.3).

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DiaSorin gets additional BARDA funding

February 2021—DiaSorin Molecular received additional federal funding from the Biomedical Advanced Research and Development Authority for the validation and submission of the Simplexa COVID-19 Direct kit and the Simplexa COVID-19 & Flu A/B Direct kit for FDA 510(k) clearance. The company initially received BARDA funding in March 2020 to test, validate, and submit the Simplexa COVID-19 Direct kit for FDA emergency use authorization.

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FDA clears Simplexa flu A/B, RSV assay

November 2020—DiaSorin Molecular received FDA clearance for its Simplexa Flu A/B & RSV Direct Gen II kit. The assay can be run alone or alongside the Simplexa COVID-19 Direct kit, allowing for differential diagnosis of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus.

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DiaSorin COVID-19 test gets EUA

March 20, 2020—DiaSorin Molecular announced it has received emergency use authorization from the FDA for its Simplexa COVID-19 Direct kit. The kit provides a sample-to-answer test for the detection of SARS-CoV-2 directly from nasopharyngeal swab specimens.

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FDA clears Simplexa VZV Swab Direct

February 2020—DiaSorin Molecular has received FDA clearance for its Simplexa VZV Swab Direct assay. The CLIA moderate-complexity assay is designed for use on the Liaison MDX instrument to detect varicella-zoster virus DNA from cutaneous and mucocutaneous swab specimens. The assay complements the company’s Simplexa VZV Direct kit, which is for use with cerebrospinal fluid samples.

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DiaSorin introduces primer pair for Candida auris

January 2020—DiaSorin Molecular has released a primer pair that targets Candida auris, for use in laboratory-developed molecular tests. Candida auris is often multidrug resistant and has caused recent outbreaks in hospitals and long-term care facilities across the U.S. and in more than 20 countries, the company reports. The primer pairs are classified as analyte-specific reagents, which can be used by ...

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Simplexa VZV Direct gets FDA clearance

June 13, 2019–DiaSorin Molecular received FDA clearance for its Simplexa VZV Direct assay for use with cerebrospinal fluid samples. The molecular diagnostic test enables the detection of varicella zoster virus DNA and aids in the diagnosis of meningitis and encephalitis.

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FDA clears Simplexa group B strep assay

Nov. 27, 2018—DiaSorin Molecular announced that the FDA has cleared its Simplexa GBS Direct assay for diagnostic use. Designed for use on the Liaison MDX instrument, the highly sensitive assay enables qualitative detection of group B Streptococcus nucleic acid from 18- to 24-hour Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women. Assay results can be used as an ...

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