Enzo has been awarded a license to provide clinical diagnostic services in Pennsylvania, which could help the eventual uptake of ColonSentry, a PCR-based colon cancer risk-stratification test manufactured by Canadian firm GeneNews and for which Enzo has exclusive distribution rights in New York and New Jersey.
While Genomic Health projects "more modest" growth for its legacy node-negative breast cancer business over the next year, newer markets in which the company is still working to secure reimbursement still represent a significant opportunity for expansion in the years ahead.
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.
The Mayo team is evaluating different capture and sequencing techniques for use in molecular diagnostics. In a recent study the researchers tested NimbleGen's capture array with both the Roche 454 GS FLX and Illumina GA. Next up will be Agilent's in-solution capture technique, RainDance's microdroplet PCR technology, and standard PCR enrichment.
Potsdam-based Signature Dx plans to launch by the fourth quarter of this year two array-based in vitro diagnostics for colorectal cancer. The company will first launch the tests in Europe and intends to seek US regulatory approval at an unspecified time in the future.