Last April, AdvanDx (www.advandx.com) launched Evigene™ kits to detect specific antibiotic resistance, virulence, and toxicity markers in such bacteria as methicillin-resistance (MRSA), Panton Valentine leukocidin (community-acquired MRSA), and TSST-1 (toxic shock syndrome toxin 1). “These qualitative hybridization assays are based upon nucleic acid signal amplification for three-hour detection of gene markers in S. aureus and enterococci isolates. The kits are available for research use in the U.S. and may be available for clinical use by mid-2007,” according to Philip Onigman, director of sales and marketing.
Next year, Onigman suggests AdvanDx’ PNA FISH platform will include tests for Gram negative bacteria, including E.coli and Pseudomonas. Used to rapidly identify specific bacteria species directly from positive blood cultures, the PNA FISH assay uses fluorescence-labeled probes targeting the bacteria’s rRNA. Results are available within a few hours.
Cytocore (www.cytocoreinc.com) currently is assessing the feasibility of using P2X7 to differentiate between normal and cancerous uterine cells, according to George Gorodeski, M.D., Ph.D., scientific adviser for Cytocore and professor of reproductivie biology, oncology, physiology, and biophysics, Case Western University. “P2X7 is expressed in higher levels in normal cells than in cancerous cells,” he says. Its inhibitor, a naturally expressed, truncated version called P2X7-j, however, expresses at steady levels, leading to speculation that it is a mechanism that blocks production of P2X7. Potential applications are being investigated.
The growth in molecular diagnostics means that “what used to be hard and esoteric is being done now in hospitals labs,” according to Mary Beth Carpenter of Focus Diagnostics (www.focusdx.com). “Any new product ought to be very disease-specific and should help in diagnosis, not just detecting a pathogen but determining what the presence of that pathogen means in context.”
GenomEX™, launched last November, does just that for cystic fibrosis. It is designed for hospitals and commercial labs capable of genetic testing but lacking a board-certified molecular geneticist. Additional diseases will be added gradually.
In addition to Abbott Molecular’s (www.abbott.com) established, complementary assay to determine the appropriateness of beginning a Herceptin regimen (based on the presence of the her2 gene) to treat metastatic breast cancer, the company is developing molecular tests for EGFR amplification and for bladder cancer. The latter uses FISH technology to determine early recurrence of bladder cancer. “It should be on the market in a couple of years,” Don Braakman of Abbott Molecular predicts.