NEW YORK (GenomeWeb) – The FDA said this week it is extending the comment period for two of its draft guidances: the Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff, and Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Draft Guidance for Industry and Food and Drug Administration Staff. These guidances were published on Nov. 29, 2017 to help manufacturers of IVD devices apply for and receive CLIA waivers. The first document will represent the agency's policy on the appropriate use of comparable performance between a user in a waived facility and a user in a moderately complex laboratory to demonstrate accuracy, while the second document will describe the agency's expectations regarding study designs for generating data that supports both 510(k) clearance and CLIA waiver by application. The comment period for both has been extended to March 30.
PerkinElmer this week declared a regular quarterly dividend of $.07 per share of common stock, payable on May 10 to all shareholders of record at the close of business on April 13.
Nebion and Qlucore said this week that they have "intensified" their collaboration to support the research community with the combined use of Qlucore's Omics Explorer and Nebion's Genevestigator. When used together, the tools provide scientists with data storage, pre-processing, analysis, interpretation, and comparisons with public datasets, and enable users to analyze expression data sets in full detail, characterize gene lists, and interpret results in a broad biological context, the firms said. Both companies will host seminars and webinars for research biologists to demonstrate how to best utilize these tools for data exploration and analysis. The companies began their collaboration in 2014.
IntegraGen announced this week that it has added Twist Bioscience’s Human Core Exome Complete Kit, a library prep and exome enrichment solution, to its own line of next-generation targeted sequencing product offerings. Under the terms of the agreement, Twist Bioscience will provide IntegraGen its Human Core Exome Complete Kit for all target sequencing workflows, including exome sequencing for clinical research. Terms of the deal were not disclosed.
Exosome Diagnostics this week entered into a preferred provider network agreement with America's Choice Provider Network (ACPN). Under the terms of the agreement, more than 28 million ACPN members from across the US will have access and coverage for the Exosome Dx's ExoDxProstate(IntelliScore), a urine test developed to help reduce the number of unnecessary prostate biopsies.
Millennium Health said this week it has received CAP accreditation. According to the company, the accreditation "demonstrates that [it] has attained the highest standard of excellence in laboratory practices and indicates the laboratory meets these high quality standards for the DxWound molecular microbiology test." The test is offered by CogenDx, the genetics brand of Millennium, and detects microbes, including aerobic and anaerobic bacteria, fungi, and antibiotic resistance genes. Millennium was previously CAP-accredited for molecular pathology, chemistry, and toxicology testing.
Genalyte announced this week that it received ISO certification for manufacturing medical devices, supporting the firm's cloud laboratory diagnostic testing model. Genalyte's system brings blood-based diagnostic testing to the physician's office, offering results in about 15 minutes.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on the GenomeWeb site.