Molecular Diagnostics Segment Rapidly Growing

The current market exceeds US$3.2 billion worldwide and it is expected to reach $5.4 billion in four years.

Genetic tests optimize drug therapy and companion diagnostics define a patient's need or predict the clinical outcome from a specific drug. The U.S. Food and Drug Administration's (FDA; Rockville, MD, USA) recently approved HER-2 test from Invitrogen (Carlsbad, CA, USA) called Spot-Light is one of the new molecular diagnostic tests. This test identifies breast cancer patients who are candidates for treatment with Herceptin. In addition, data were recently presented showing the importance of testing for the K-ras gene to assess the clinical benefit of Erbitux for metastatic colorectal cancer.

The companies Affymetrix (Santa Clara, CA, USA) and Illumina (San Diego, CA, USA) have both created array-based products that enable high-speed analysis of DNA, RNA, and proteins as tools for molecular tests, drug development, and disease research. These gene-sequencing tools are being applied at an earlier stage in diseases.

Of all the larger integrated healthcare companies, Roche (Basel, Switzerland) has best implemented the synergies derived from molecular diagnostics and biopharmaceutics 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.

A report by Mary Anne Liebert, published on October 10, 2008, in Genetic Engineering News, indicated that the growth in successful molecular diagnostic products is significant and supports Kalorama Information's (Rockville, MD, USA) predictions for this market, which appeared in the October 1, 2008, issue of the journal Genetics. Kalorama Information is an international market research company

"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,” noted John Sterling, editor-in-chief of Genetics. "Molecular diagnostics are particularly applicable to the early detection of cancer.”

Related Links:
U.S. Food and Drug Administration
Invitrogen
Affymetrix
Illumina
Roche
Kalorama Information