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Put It on the Board, 11/16

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FDA approves Ventana PD-L1 (SP142) assay

Access TSH (3rd IS) assay cleared for Beckman systems

Advanced MALDI-TOF use subject of AMP report

FDA clearance for Quidel Solana influenza A+B

FDA approves Ventana PD-L1 (SP142) assay

Roche last month announced FDA approval of the Ventana PD-L1 (SP142) assay as a complementary diagnostic to identify PD-L1 expression levels in patients considering treatment with the FDA-approved Roche cancer immunotherapy Tecentriq (atezolizumab) for previously treated metastatic non-small cell lung cancer. The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer who may benefit from treatment with Tecentriq.

The assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP142 intended for use in assessing the PD-L1 protein in formalin-fixed, paraffin-embedded urothelial carcinoma and non-small cell lung cancer tissue stained with Opti­View DAB IHC Detection Kit and OptiView Amplification Kit on a Ventana BenchMark Ultra instrument. Determination of PD-L1 status is indication-specific, and evaluation is based on either the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (percent IC) of any intensity or the percentage of PD-L1 expressing tumor cells (percent TC) of any intensity.

PD-L1 expression in ≥ five percent IC determined by Ventana PD-L1 (SP142) assay in urothelial carcinoma tissue is associated with increased objective response rate in a non-randomized study of Tecentriq.

PD-L1 expression in ≥ 50 percent TC or ≥ 10 percent IC determined by the assay in NSCLC tissue may be associated with enhanced overall survival from Tecentriq.

Roche says its assay is the first to evaluate patient PD-L1 expression using both tumor cell and immune cell staining, and that it will continue to pursue regulatory approval for the assay in combination with Tecentriq in other cancer indications and in other geographies.
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Access TSH (3rd IS) assay cleared for Beckman systems

Beckman Coulter Diagnostics has released its FDA-cleared Access TSH (3rd IS) assay for use with the Access family of immunoassay systems. The new assay is the next-generation of the Access HYPERsensitive hTSH and Access Fast hTSH assays for the quantitative determination of human thyroid-stimulating hormone.

The assay is standardized to the World Health Organization 3rd International Standard for human TSH (IRP 81/565). The assay range supports measuring patient samples as low as 0.01 µIU/mL, and the reagent pack size is 100 tests/pack, 200 tests/kit.
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Advanced MALDI-TOF use subject of AMP report

The Association for Molecular Pathology has published a new report on the likely next uses of MALDI-TOF mass spectrometry, beyond its use for bacteria and yeast: the identification of filamentous fungi and mycobacteria. Less clear, the report says, is what role MALDI-TOF MS will play in antimicrobial susceptibility testing.

The report on the emerging and future applications of MALDI-TOF mass spec in the clinical microbiology lab was released online in October and is published in the November 2016 issue of the Journal of Molecular Diagnostics.

After a thorough evaluation, the AMP MALDI-TOF in Infectious Diseases Work Group determined that MALDI-TOF mass spec could successfully identify filamentous fungi, such as Aspergillus, and mycobacteria, such as M. tuberculosis. However, the team believes that more testing must be performed before it can recommend the use of MALDI-TOF mass spec for antimicrobial susceptibility applications.

“Several proof-of-principle studies have been published and have demonstrated the ability of MALDI-TOF MS to detect β-lactamase activity, rRNA methylation, porin mutation, and VRE,” the authors write. “However, workflow for these assays remains cumbersome, and full susceptibility testing must still be performed. As such, until quantitative methods are fully developed, MALDI-TOF MS resistance testing will probably be used as an adjunct to routine testing in specific clinical scenarios. . . .”

For filamentous fungi and mycobacteria, safety in processing remains a concern and a consideration in protocol development, says the AMP work group, led by Christopher Doern, PhD, associate director of microbiology, Virginia Commonwealth University Health System. “A growing body of literature now suggests that relatively rapid protocols can be used to safely process these organisms while generating quality spectra. Although these methods are capable of reliably identifying fungi and mycobacteria, it is important that organisms be processed with the same method that was used to generate the reference database.” MALDI-TOF can be used to identify these organisms, the group says, and manufacturers are developing protocols and databases. Although the databases are not FDA approved at this time, MALDI-TOF mass spec is likely to become the standard of practice soon for identifying fungi and mycobacteria, according to the report.

Susan Butler-Wu, PhD, of the Keck School of Medicine of the University of Southern California, is a coauthor with Dr. Doern of the report.
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FDA clearance for Quidel Solana influenza A+B

Quidel Corp. has received 510(k) clearance from the FDA to market its Solana Influenza A+B assay for the detection of nucleic acids isolated from nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection to aid in the diagnosis of influenza A and B infections. The assay is intended for use only with the Solana instrument.

The Solana molecular platform leverages Quidel’s helicase-dependent amplification technology, and in the case of the Solana influenza A+B assay, a novel reverse-transcriptase HDA, that is resident in Quidel’s AmpliVue molecular product line to generate a fast and accurate test result, says a company statement. Solana can process up to 12 patient samples in each 45-minute run.

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