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.
European customers using or planning to use the 7500 Fast Dx instrument to develop in vitro diagnostic content now have a "much easier" path when submitting a complete IVD platform for regulatory approval by European authorities, a Life Tech official said.