News

DiaSorin Molecular Secures FDA Clearance for Group B Strep Assay

Cypress, Calif. (November 26, 2018) – DiaSorin Molecular LLC announced today that the FDA has cleared its new Simplexa^TM 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 (GBS) 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 aid in determining the colonization status of antepartum women. The new assay can replace traditional culture testing methods and features an efficient, fast workflow. This is the ninth assay for infectious disease on DiaSorin Molecular’s PCR platform to obtain FDA 510(k) clearance.

DiaSorin Molecular Attains CE Mark for Simplexa^TM Group B Strep Direct Molecular Assay

Cypress, Calif. (October 18, 2018) – DiaSorin Molecular LLC announced today that it has attained CE marking for its new Simplexa^TM Group B Strep Direct assay. Designed for use on the LIAISON^® MDX instrument, the highly sensitive assay enables the direct in vitro detection of Group B Streptococcus (GBS DNA). GBS infection is a significant challenge in the health management of women and newborns. The new assay is more specific than traditional testing methods and features an efficient, fast workflow. This assay has also been submitted to the FDA under their Premarket Notification process, to obtain 510(k) clearance.

DiaSorin Molecular Attains CE Mark for Simplexa™ VZV Direct Molecular Assay

Cypress, Calif. (October 2, 2018) – DiaSorin Molecular LLC announced today that it has received CE marking for its new SimplexaTM VZV Direct assay. The new molecular diagnostic test enables the direct detection of varicella-zoster virus (VZV) DNA from cerebrospinal fluid (CSF). The assay was designed for use on the LIAISON® MDX instrument and will be able to run alongside DiaSorin Molecular’s Simplexa HSV 1 & 2 Direct assay, generating comprehensive and actionable insight for patients with suspected infections of the central nervous system (CNS).

DiaSorin Molecular LLC’s Simplexa® HSV 1 & 2 Direct Assay Receives FDA Clearance for Extended Swab Sample Claims

DiaSorin Molecular LLC announced today that the company has received FDA clearance extending the sample type claims of its Simplexa^® HSV 1 & 2 Direct assay. The clearance expands the type of samples that can be tested, from genital swabs to all cutaneous and mucocutaneous swab samples. FDA clearance of the assay for testing cerebrospinal fluid (CSF) samples was received in 2014. With these additional sample types, the DiaSorin Molecular Simplexa HSV 1 & 2 assay now has the most comprehensive sample type coverage for HSV testing in the market. CE Marking for these extended sample claims was attained late last year.

DiaSorin Molecular Introduces Primer Pair Reagents for
A. phagocytophilum, Ehrlichia and Babesia

DiaSorin Molecular LLC introduces three new primer pairs for use in laboratory-developed molecular tests. The reagents are specific to three bacterial targets – Anaplasma phagocytophilum, Ehrlichia and Babesia species. These bacteria are commonly carried by ticks. The new offerings join DiaSorin Molecular’s menu of more than 60 molecular reagents for bacterial, viral and fungal targets in addition to human genetic mutations. The primer pairs are classified as Analyte Specific Reagents (ASRs), which can be used by high-complexity laboratories to develop their own laboratory-developed tests (LDTs).

DiaSorin Molecular Launches New Simplexa™ Bordetella Direct Molecular Test

DiaSorin Molecular LLC receives CE Mark for a new Bordetella molecular diagnostic test. Simplexa™ Bordetella Direct is designed to quickly provide qualitative detection and differentiation of both Bordetella pertussis and Bordetella parapertussis in human nasopharyngealswabs.

DiaSorin Molecular Introduces Two Primer Pair Reagents for Streptococcus

DiaSorin Molecular Introduces Primer Pair Reagent for Pneumocystis jirovecii

DiaSorin Molecular announces the expansion of its menu of molecular reagents with the introduction of a P. jirovecii primer pair for use in laboratory-developed molecular tests. (more…)

Extended CE-IVD Certification Expands Sample Claim for DiaSorin Molecular’s Simplexa^™ HSV 1 & 2 Kit

DiaSorin Molecular Receives FDA Clearance for Reliable C. difficile Assay on LIAISON^® MDX Platform

The new assay runs on the company’s LIAISON^® MDX system, a scalable benchtop PCR instrument that delivers qualitative and quantitative, sample-to-answer, multi-analyte results. The Simplexa assay detects the Clostridium difficile toxin B gene (tcdB), present in liquid or unformed stool samples, aiding in the diagnosis of C. difficile infection.