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.
Read More »DiaSorin releases updated Simplexa SARS-CoV-2 Variants Direct
March 2022—DiaSorin Molecular has released an updated version of its Simplexa SARS-CoV-2 Variants Direct assay, for research use only, to enable the detection of mutations associated with the omicron variant B.1.1.529.
Read More »DiaSorin updates RUO Simplexa SARS-CoV-2 Variants Direct
Jan. 14, 2022—DiaSorin Molecular has released an updated version of its Simplexa SARS-CoV-2 Variants Direct assay, for research use only, to enable the detection of mutations associated with the omicron variant (B.1.1.529).
Read More »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.
Read More »Simplexa COVID-19, flu A/B assay assay gets CE mark
Sept. 21, 2021—DiaSorin Molecular announced that it has CE marked its Simplexa COVID-19 and Flu A/B Direct kit.
Read More »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).
Read More »DiaSorin releases Simplexa SARS-CoV-2 Variants Direct assay
May 25, 2021—DiaSorin Molecular has released the Simplexa SARS-CoV-2 Variants Direct assay, for research use only, to enable the detection and discrimination of four SARS-CoV-2 mutations associated with circulating virus variants without requiring upfront RNA extraction.
Read More »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.
Read More »DiaSorin COVID-19 assay gets CE mark for saliva specimens
January 2021—DiaSorin Molecular has attained CE marking for the addition of saliva specimens for use with the Simplexa COVID-19 Direct assay.
Read More »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.
Read More »Simplexa Flu A/B & RSV Direct Gen II gets CE mark
September 2020—DiaSorin Molecular announced that its Simplexa Flu A/B & RSV Direct Gen II kit has received the CE mark. The kit delivers continued comprehensive strain coverage and accurate detection in a sample-to-answer format that does not require extraction.
Read More »FDA clears Simplexa Flu A/B & RSV Direct Gen II assay
Sept. 8, 2020—DiaSorin Molecular received FDA clearance for its Simplexa Flu A/B & RSV Direct Gen II kit.
Read More »Simplexa Congenital CMV Direct kit gets CE mark
August 2020—DiaSorin Molecular announced it has received the CE mark for its Simplexa Congenital CMV Direct kit. The molecular diagnostic test enables direct detection of cytomegalovirus DNA in saliva swab and urine specimens from babies up to 21 days old.
Read More »Simplexa Flu A/B & RSV Direct Gen II assay gets CE mark
July 9, 2020—DiaSorin Molecular announced that its Simplexa Flu A/B & RSV Direct Gen II kit has received the CE mark.
Read More »Simplexa Congenital CMV Direct kit gets CE mark
June 24, 2020—DiaSorin Molecular announced it has received the CE mark for its Simplexa Congenital CMV Direct kit.
Read More »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.
Read More »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.
Read More »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 ...
Read More »DiaSorin receives FDA clearance for Simplexa VZV Swab Direct
Dec. 19, 2019—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.
Read More »DiaSorin VZV swab test gets CE mark
December 2019—DiaSorin Molecular received the CE mark for its Simplexa VZV Swab Direct assay. The molecular diagnostic test enables the direct detection of varicella-zoster virus DNA from cutaneous and mucocutaneous swab specimens.
Read More »Simplexa VZV Swab Direct assay gets CE mark
Sept. 27, 2019–DiaSorin Molecular received the CE mark for its Simplexa VZV Swab Direct assay. The molecular diagnostic test enables the direct detection of varicella-zoster virus DNA from cutaneous and mucocutaneous swab specimens.
Read More »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.
Read More »Primer pairs for atypical pneumonia
February 2019—DiaSorin Molecular announced the availability of three new primer pairs for atypical pneumonia that can be used in laboratory-developed tests. The specific targets are Legionella species, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.
Read More »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 ...
Read More »DiaSorin Molecular primer pair reagents
July 2018—DiaSorin Molecular introduced three primer pairs for use in laboratory-developed molecular tests.
Read More »DiaSorin Molecular primer pair reagents, 12/17
December 2017—DiaSorin Molecular introduced group C and group G Streptococcus primer pairs and a Pneumocystis jirovecii primer pair for the amplification and detection of the Pneumocystis jirovecii mtLSU gene with a CFR610- and BHQ-2-labeled probe and forward and reverse primers.
Read More »C. diff assay cleared for Liaison MDX, 11/17
November 2017—DiaSorin Molecular announced the U.S. introduction of the Simplexa C. difficile Direct Assay upon receiving clearance from the Food and Drug Administration.
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