Blood Test for Diagnosis and Prognosis of Bipolar Disorder

McLean Hospital
posted on 01/20/2011

Although bipolar disorder appears to be heritable, no single genetic locus has been repeatedly linked to this condition, and the mechanisms underlying the disorder remain unknown. In the inventors’ previous research, the regulation of 13,000 genes in brain tissue from patients with bipolar disorder was examined, and numerous changes in expression levels of genes were found in the brains of subjects suffering from bipolar disorder compared to control subjects (McLean invention reference MCL 2256.0). The greatest differences were seen in genes whose expression products involve mitochondrial function or energy utilization. In more recent research, the inventors found that differential expression of certain of these genes can also be seen in lymphocytes of bipolar subjects compared to controls, when the lymphocytes are treated ex vivo in a certain manner. Specifically, lymphocytes of normal controls responded to glucose deprivation with an up-regulation of nuclear transcripts for proteins of the electron transfer chain, whereas subjects with bipolar disorder had a tendency to down-regulate these transcripts (McLean invention reference MCL 3104.0).
Real-time quantitative polymerase chain reaction analysis for low glucose for bipolar disorder (BPD) lymphocytes (n=16) vs normal control (NC) lymphocytes (n=15). Four genes were used in the quantitative PCR verification. *P =0.05. P=0.01. From Naydenov, et al. 2007 PMID 17485607.
Potential Commercial Uses: By enabling circulating cells to be used in this assay, the new research enables a simple, rapid blood test that can be used to diagnose bipolar disorder. The invention features a diagnostic method for detecting the presence of, or propensity for, bipoloar disorder in a patient by detecting specific patterns of gene expression in lymphocytes subjected to a specific ex vivo treatment. The test is simple and easy to carry out, in that it can be conducted using easily-obtainable blood samples from patients, using standard methods of measuring gene expression. The test provides a quick diagnosis of whether the patient has a genotype which puts him or her at risk of developing psychotic disorders such as bipolar disorder.
Patent Status: McLean Hospital is the owner of pending U.S patent applications claiming this invention.
The research underlying the invention has been published as Konradi et al. (2004) Arch. Gen. Psychiatry 61:300-308 PMID 14993118 and Naydenov, et al. (2007) Arch Gen Psychiatry 64:555-564 PMID 17485607.
Licenses Available: McLean Hospital is offering a worldwide exclusive license to this technology.