IVD

After appointing a new CEO this summer, SQI Diagnostics is continuing its focus on services to pharmaceutical partners in providing custom multiplex immunogenicity panels, with its pipeline of in vitro diagnostics assays as a second priority, the company said this week.

Luminex hopes to see two new screening assays cleared by the US Food and Drug Administration next year that together address a market opportunity of about $200 million.

Members of a US House of Representatives subcommittee have called on the US Food and Drug Administration to respond to "significant concern" regarding the agency's draft guidance document on research-use-only and investigational-use-only diagnostic products.

The US Centers for Disease Control said late last week that its newest in vitro diagnostic testing panel for seasonal and pandemic influenza strains has been authorized for use by the US Food and Drug Administration.

The latest iteration of a bill being drafted by Republican Senator Orrin Hatch includes new proposals to bring "follow-on" diagnostics to market and a process for grandfathering in already-commercialized IVD products. Other issues, such as the development of a market-based pricing model for advanced personalized diagnostics, are still under consideration.

The company is developing and validating assays for difficult-to-treat and drug-resistant infectious diseases based primarily on targets, biomarkers, and PCR primers developed at the Translational Genomics Research Institute and Northern Arizona University.

The test, which amplifies and detects methylated Septin9 DNA from patient plasma samples, has been shown to identify a higher proportion of colorectal cancers than Quest Diagnostics' laboratory-developed test, called ColoVantage; as well as CE-marked in vitro diagnostics offered in Europe by Epigenomics and Abbott.

Life Tech officials said that Stokes Bio's microfluidics-based technology platform will enable high-throughput, PCR-based genetic analyses for a variety of applications, particularly in the area of agricultural biology.

Synlab has started offering Epi proColon, Epigenomics' PCR-based blood test for early detection of colorectal cancer, through 55 German sites in its network. In addition, Epigenomics recently raised €33.1 million ($44.2 million) through a combined private and public share offering.

Pages

An Australian-led team has generated a draft genome assembly of the invasive cane toad in hopes it will help in population control, the Sydney Morning Herald reports.

The New York Times reports that the US Department of Defense has implemented about half the recommendations made to improve safe handling of dangerous agents.

In PLOS this week: approach for teasing out archaic introgression in human genomes, immune transcription features in HCV infection, and more.

Stat News reports that Maryland is promoting itself to the biotech industry with a mobile billboard.