Words like “schizophrenia” and “bipolar disorder” have guided psychiatric treatment for decades, but they may be meaningless labels that mask a lack of real knowledge about the molecular events behind these related constellations of symptoms. That’s the critical view that greeted the latest edition of the psychiatrists’ “bible,” the Diagnostic and Statistical Manual of Mental Disorders, or DSM-5, published by the American Psychiatric Association in late May.
Among those critics is Thomas Insel, director of the National Institute of Mental Health, who highlighted the debate about the DSM-5 in an April blog post. Insel called for the discovery of biomarkers that could both re-categorize common mental illnesses and open doors to better therapies. This work has already begun at companies such as Austin, TX-based Myriad RBM, a subsidiary of diagnostic testing company Myriad Genetics (Nasdaq:MYGN) of Salt Lake City, UT.
Myriad RBM, formed in 2002 as Rules-Based Medicine, was an early developer of protein assay panels that test not only for known disease biomarkers, but also for other proteins that might be unsuspected troublemakers. As a partner with researchers at the University of Cambridge, UK, RBM developed an experimental test for schizophrenia in 2009. That led to an ongoing collaboration with Roche—one of a number of notable partners RBM gained before it was acquired in 2011 by Myriad.
Myriad, a genetic testing pioneer founded in 1991, built its business around its early flagship test, BRACAnalysis, which looks for variations in two genes that significantly elevate a woman’s risk of breast cancer. Myriad controlled the market for BRACA gene testing due to its portfolio of gene patents, but some of those have now been invalidated by the US Supreme Court in its June 13 ruling. The market impact of the ruling on BRACAnalysis is yet to be seen, but competition is likely to increase among providers of tests based on single genes that powerfully increase disease risk. However, many diseases result from an interplay of multiple gene mutations, and diagnostic companies are using their knowledge of those interactions to add value to their diagnostic products.
Myriad moved in that direction when it acquired RBM for $80 million, augmenting its DNA and RNA screening repertoire with proficiency in protein detection.
“Few other companies have expertise in all three,” says Craig Benson, president of Myriad RBM. “We sort of used to say we complete the Triple Crown of molecular biology diagnostics.” The company’s protein assay panels now cover a range of focus areas including oncology, cardiovascular disease, and inflammation.
Myriad RBM’s primary customers are pharmaceutical companies and research institutions that are looking for help in drug development and clues to the core mechanisms of disease. Benson, who joined Rules-Based Medicine at its birth as a spin-off from Austin, TX-based Luminex (NASDAQ: LMNX) says the company had to persuade clients at first that they should look beyond the biomarkers that were already known to be associated with the diseases they were researching and use RBM’s fuller “multiplexed” assay panels.
RBM’s founding principle was that complex diseases such as neuropsychiatric disorders would only be fully understood by examining multiple molecular factors, and the relationships among those factors in different individuals.
“We almost forced customers to think about things in a different way,” Benson says. “It was a little bit of evangelizing in the early days.”