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Tag Archives: Put It on the Board —

Put It on the Board

Cobas HPV test approved for first-line screening using SurePath preservative fluid
August 2018—Roche received FDA approval for the Cobas HPV test to be used as the first-line screening test for cervical cancer in women 25 and older using specimens collected in SurePath preservative fluid. The Roche test is now the only HPV test approved for use as a primary screening test with both SurePath and ThinPrep PreservCyt Solution. It is approved for all of the screening indications supported by guidelines—primary screening in women 25 and older, reflex testing of unclear Pap test results in women 21 and older, and cotesting with a Pap test in women 30 and older—with both of the primary collection media types. “With this additional approval for the Cobas HPV Test, laboratories and clinicians now have an approved option that can be used for all of their HPV screening indications and sample types,” Ann Costello, head of Roche tissue diagnostics, said in a statement.

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Put It on the Board

High-sensitivity troponin I assay available in the U.S.
July 2018—Beckman Coulter Diagnostics received 510(k) clearance from the Food and Drug Administration for its new high-sensitivity troponin assay, Access hsTnI, for use on the Access 2, DxI, and the entire Access family of immunoassay systems. Access hsTnI demonstrates less than 10 percent CV at the upper reference limits for men and women and detects troponin in more than 50 percent of the healthy population. In an independent study, Access hsTnI detected more than 99 percent of troponin values for healthy men and women (Pretorius CJ, et al. Clin Biochem. 2018;​55:​49–55). “Beckman Coulter’s high-sensitivity cardiac troponin I assay can measure very low cardiac troponin concentrations with excellent precision. This test may help physicians with both the early diagnosis of myocardial infarction and future risk stratification in and outside the acute coronary syndrome setting,” Peter Kavsak, PhD, associate professor, Department of Pathology and Molecular Medicine, McMaster Uni­versity, said in a statement.

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June 2018—FDA clears T2Bacteria panel for detecting sepsis-causing pathogens: T2 Biosystems received market clearance from the Food and Drug Administration for the T2Bacteria panel for the direct detection of bacterial species in human whole blood specimens from patients with suspected bloodstream infections.

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Put It on the Board, 5/18

May 2018—FDA approves osimertinib for NSCLC, nivolumab + ipilimumab for RCC: The FDA on April 18 approved osimertinib (Tagrisso, AstraZeneca) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

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Put It on the Board, 4/18

April 2018—CMS changes proposed policy on NGS for cancer patients: The CAP and the Association for Molecular Pathology, in separate statements in March, lauded the Centers for Medicare and Medicaid Services for revising its national coverage determination on next-generation sequencing.

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Put It on the Board, 3/18

March 2018—AMP issues recommendations for clinical CYP2C19 genotyping allele selection: To promote standardized testing across laboratories, the Association for Molecular Pathology published on Feb. 27 consensus, evidence-based recommendations for designing and validating clinical CYP2C19 assays.

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Put It on the Board, 2/18

February 2018—PreludeDx unveils predictive assay for DCIS: PreludeDx announced results from its oral presentation at the San Antonio Breast Cancer Symposium. The results using the SweDCIS randomized trial confirmed that the DCIS­ion­RT test predicts which patients with ductal carcinoma in situ will benefit from radiation therapy after breast-conserving surgery.

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Put It on the Board, 1/18

January 2018—Some safety issues more gray than black and white: Most laboratory safety rules are free from ambiguity. Anyone who handles specimens must wear personal protective equipment, for example. Some issues are less clearly defined, though, and require a deeper dive into the guidelines. That is where Dan Scungio, MT (ASCP), SLS, CQA(ASQ), comes in.

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Put It on the Board, 12/17

December 2017—FDA announces IMPACT authorization and path for authorization of other tumor profiling tests: The FDA on Nov. 15 authorized Memorial Sloan Kettering Cancer Center’s IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) tumor profiling test. The IMPACT test uses next-generation sequencing to identify the presence of mutations in 468 unique genes, as well as other molecular changes in the genomic makeup of a tumor.

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Put It on the Board, 11/17

November 2017—Study finds biotin interference; FDA clears Flu A/B/RSV assay on Hologic’s Panther Fusion; FDA clears Abbott’s Alinity ci-series; Sysmex introduces CyFlow Antibodies for flow cytometry; Test approved for screening Zika in blood donations; New insights into female reproductive tract development

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