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“Not all pathologists need to be actively involved in these types of activities,” they write, “but there should be a champion within the institution that can represent the value of laboratory data to administration.”

Roche launches first IVD pan-TRK IHC assay

Roche launched the Ventana pan-TRK (EPR17341) assay, the first automated in vitro diagnostic immunohistochemistry assay to detect tropomyosin receptor kinase proteins in cancer.

With the launch, Roche says, laboratories are now able to identify wild-type and chimeric fusion proteins through detection of the TRK C-terminal region. This assay can be used to perform analytic studies, including prevalence in solid tumors.

The assay is available for use on Roche’s BenchMark series of IHC/ISH automated staining instruments. It is designed to detect C-terminal protein expression, which allows for the detection of TRK-fusion as well as wild-type protein expression. The epitope detected by the antibody is encoded downstream of the tyrosine kinase domain within the 3 prime coding region of the neurotrophic tyrosine receptor kinase (NTRK) 1, 2, and 3 genes and is conserved across all three TRK proteins, A, B, and C.

FDA clears DiaSorin Molecular GBS Direct assay

The FDA cleared DiaSorin Molecular’s new Simplexa GBS Direct assay for diagnostic use.

Designed for use on the Liaison MDX instrument, the 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 aid in determining the colonization status of antepartum women. The company says 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.

Breakthrough device designation for Enhanced Liver Fibrosis Test

The FDA granted a breakthrough device designation for the Advia Centaur Enhanced Liver Fibrosis Test from Siemens Healthineers.

The ELF Test would support clinicians, in conjunction with additional clinical evidence, in assessing the fibrosis stage of chronic liver disease through a simple blood test, which may help determine if a patient requires treatment. The ELF Test is designed to analyze data regarding three serum biomarkers—hyaluronic acid, procollagen III amino-terminal peptide, and tissue inhibitor of metalloproteinase 1—in an algorithm that provides a single ELF score.

Siemens Healthineers is collaborating with Gilead Sciences as part of its work to seek FDA clearance of the ELF Test.

NeuMoDx Molecular launches 288 and 96 molecular systems

NeuMoDx Molecular launched its FDA-cleared NeuMoDx 288 Molecular System and its FDA-listed NeuMoDx 96 Molecular System.

The fully automated systems integrate the molecular diagnostic process, from extraction to detection, with the first result available in about one hour. Operators can load up to 288 and 96 patient samples in a continuous, random-access workflow, resulting in on-demand, high-throughput sample processing with an operator walkaway window of up to eight hours.

The proprietary NeuDry reagents used with the systems require no refrigeration and have an onboard stability of up to 60 days and ambient temperature shelf life of greater than one year.

Expanded use approved for Vitros HIV Combo test

Ortho Clinical Diagnostics’ Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator received FDA approval for use on the Vitros ECi/ECiQ Immunodiagnostic Systems. The Vitros HIV Combo test was previously approved for use on the Vitros 5600 Integrated System and Vitros 3600 Immuno­diagnostic System.

Vitros HIV Combo, a fourth-generation test, detects both HIV-1 and HIV-2 antibodies and the p24 antigen.