Novel platform technologies and key advances in genomics are rapidly driving the development of molecular diagnostics, reports Genetic Engineering and Biotechnology News (GEN). The payoff for successful molecular diagnostic products can be significant as Kalorama Information predicts that this market currently exceeds $3.2 billion worldwide and will reach $5.4 billion in four years, according to an article in the October 1 issue of GEN.
“Molecular diagnostic products are based on cutting-edge research in two of the most promising biotechnologies, genomics and proteomics. These novel tests also utilize sophisticated analytical techniques such as microarrays and mass spectrometry,” notes John Sterling, Editor-in-Chief of GEN. “Molecular diagnostics are particularly applicable to the early detection of cancer.”
Affymetrix and Illumina have both created array-based products that enable high-speed analysis of DNA, RNA, and proteins as tools for disease research, drug development, and molecular tests. These gene-sequencing tools are being applied at an earlier stage.
Genetic tests can optimize drug therapy, and companion diagnostics are being touted as a method to better define a patient’s need or predict clinical outcome from a specific drug. The FDA recently approved a HER-2 test from Invitrogen called Spot-Light that can be used to identify breast cancer patients who are candidates for treatment with Herceptin. In addition, data was recently presented showing the importance of testing for the K-ras gene to assess the clinical benefit of Erbitux for metastatic colorectal cancer.
Of all the larger integrated healthcare companies, Roche has best executed the synergies of molecular diagnostics and biopharmaceuticals and is well positioned for the future with products in oncology and infectious disease. Its genetic tests include CYP450 for drug metabolism studies and HER-2 for use with tamoxifen therapy.