Fertility Testing

FDA Clears Cyperus Sperm Separation Device for Fertility Labs

Contrario Medical's single-use device uses a two-membrane design to prepare motile sperm from semen samples.

Fertility Testing

Kindbody Launches Kindlabs for In-House Genetic Testing

Kindlabs offers a verticalized genetic testing platform, from wet lab chemistry to software and bioinformatics.

Fertility Testing

Portfolio of Reproductive Information-Driven Genomic Solutions Introduced

Sema4 Elements, a portfolio of information-driven genomic reproductive health solutions that enable providers to treat patients holistically, has launched.

Molecular Assays Focus on Diagnostic Testing for Vaginitis

Jul 23, 2019 | Fertility Testing, Microscopy, Sexually Transmitted Diseases, Womens Health

Improved accuracy in detecting bacterial vaginosis, Candida vaginitis, and Trichomonas vaginalis will enable more targeted treatment for women.

FDA Clears First Diagnostics for Extragenital Chlamydia and Gonorrhea

Jul 12, 2019 | Fertility Testing, Sexually Transmitted Diseases, Womens Health

The Aptima Combo 2 and Xpert CT/NG are the first assays cleared to perform extragenital diagnostic testing for chlamydia and gonorrhea via specimens from the throat and rectum.

LGC Maine Standards Releases Validate LP Kit to Enhance Linearity and Calibration Verification

Jun 13, 2019 | Fertility Testing, Standards, Womens Health

The Validate LP kit for Advia and Atellica analyzers from Siemens Healthineers addresses a growing demand from laboratories in need of a product to document HDL and LDL linearity and calibration verification.

April 2019 Product Spotlight: Immunoassay Analyzers

May 21, 2019 | Fertility Testing, Immunoassay, Microbiology Instruments, Womens Health

April 2019’s product spotlight includes immunoassay kits and analyzers from companies such as Fujirebio, Ansh Labs, Tosoh Bioscience, and more.

LGC Maine Standards Adds Cerebrospinal Fluid Total Protein to Validate Body Fluids Kit

Feb 6, 2019 | Fertility Testing, Standards, Womens Health

The addition allows for easier validation of laboratory-developed tests, documentation of linearity and calibration verification, and verification of reportable range.

New Test Enables Resistance-Guided Therapy for Gonorrhea

Jan 31, 2019 | Fertility Testing, Infectious Diseases, Molecular Diagnostics, Sexually Transmitted Diseases, Womens Health

The ResistancePlus GC molecular diagnostic simultaneously diagnoses N. gonorrhoeae and provides antimicrobial susceptibility information, overcoming many of the issues associated with culture-based methods.

FDA Permits Marketing of First Test to Aid in the Diagnosis of Mycoplasma genitalium Infection

Jan 31, 2019 | Controls, Fertility Testing, Swabs, Womens Health

Hologic’s first-in-category assay, cleared through FDA’s De Novo review process, provides laboratories with a highly sensitive and specific molecular diagnostic method to identify M. genitalium infections and enable effective treatment.

Validate CM2 Kit for Ortho Vitros Analyzers

Jan 11, 2019 | Fertility Testing, Standards, Womens Health

The kit assists laboratories in documenting their linearity and calibration verification for hs-CRP, NT-proBNP, and TnI assays.

FDA Clears MenoCheck as an Aid in the Determination of Menopausal Status

Dec 12, 2018 | Calibrators, Cardiovascular, Controls, Fertility Testing, Heart Disease, Osteoporosis, Womens Health

The MenoCheck assay was developed to aid physicians in determining the status of women during menopausal transition.

Validate hsTnT Kit for Linearity and Calibration on Roche Cobas Analyzers

Oct 20, 2018 | Fertility Testing, Software, Standards, Womens Health

Validate hsTnT for Roche Cobas is the only linearity and calibration verification product specifically targeting Roche’s Troponin T Gen 5 Stat (TnTG5) assay.

Validate Heparin Linearity and Calibration Kit for Siemens Sysmex Analyzers

Sep 28, 2018 | Fertility Testing, Standards, Womens Health

Validate heparin for Siemens Sysmex analyzers addresses laboratories’ need for a product to document heparin anti-Xa test linearity and calibration verification.

Spectrum Preimplantation Genetic Testing for Aneuploidy Improves IVF Outcomes

Sep 17, 2018 | Fertility Testing, Research, Womens Health

Natera’s genetic test evaluates the number of chromosomes in embryos to detect extra or missing chromosomes, and screens for inherited genetic disorders.