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DiaSorin Molecular Receives FDA Clearance for Bordetella Test

Cypress, Calif., January 8, 2019 – DiaSorin Molecular LLC announced today that it has received FDA clearance for its new Simplexa® Bordetella Direct test. This CLIA moderate-complexity assay is designed for use on the LIAISON® MDX to quickly provide qualitative detection and differentiation of both Bordetella pertussis and Bordetella parapertussis in nasopharyngeal swabs (NPS). The assay is performed directly from NPS samples without extraction and provides results in about an hour.

DiaSorin Molecular Introduces Three New Primer Pairs for Atypical Pneumonia

Cypress, Calif. (December 20, 2018) – DiaSorin Molecular LLC announces the availability of three new primer pairs, or Analyte Specific Reagents (ASRs), which can be used in laboratory-developed tests (LDTs). The specific targets are Legionella species, Chlamydophila pneumoniae and Mycoplasma pneumoniae, all of which may infect the lungs.

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 SimplexaTM 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.

DiaSorin Molecular Attains CE Mark for SimplexaTM 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 SimplexaTM 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,

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).