An at-home bipolar test, launched in February 2008 and sold over the Internet, is meant to be used with a doctor's evaluation to make a correct diagnosis of bipolar disorder more quickly.
"Sales continue to be brisk," says Kurt May, CEO and founder of Psynomics Inc., the San Diego-based company producing the $399 at-home test for bipolar disorder, the latest in an array of tests marketed to consumers who want to know their risk for various diseases.
Bipolar disorder is a serious diagnosis that affects more than 10 million Americans. Unlike depression, bipolar disorder is equally common in men and women. The onset of the condition typically occurs in the early 20s, but (although rare) the first symptoms can appear in early childhood or late in life.
Although some people may have only one episode, bipolar disorder is a lifelong condition that usually involves recurrent episodes. It's usually marked by episodes of mania or hypomania (low-grade...
But some mental health experts are skeptical about the test, saying that while its premise shows promise, more research about the genetic links to bipolar disorder is needed to back up the credibility of such tests.
On one point proponents and critics alike agree: The bipolar test doesn't tell users if they do or don't have the mental illness. Rather, it reveals whether their genetic makeup may put them at higher risk of having it -- or getting it.
The bipolar test, called Psynome, looks for two mutations in a gene, GRK3, associated with bipolar disorder. The test is based on the long-term work of John Kelsoe, MD, a board-certified psychiatrist and professor of psychiatry at the University of California San Diego, who is co-founder of the company and serves as executive vice president.
People who have either of the two gene mutations, are white, are of Northern European ancestry, and have a family history of bipolar disorder are three times more likely to have bipolar disorder themselves, according to the company web site. Research has not shown such an association for other ethnic groups, according to Psynomics.
"This test is different than others that are truly home tests," says Martin Schalling, MD, PhD, a professor of medical genetics at the Karolinska Institutet in Stockholm, Sweden, and a member of the scientific advisory board for Psynomics. "The results go to the treating physician."
Purchasers are mailed a "spit kit" and are instructed to deposit saliva into the kit's resealable container, then mail the saliva sample back to Psynomics.
A second genetic test is also available. It predicts a patient's likely response to serotonin-based drugs, the most widely prescribed class of psychiatric drug therapy today, according to the Psynomic web site. It also costs $399. If both tests are ordered together, the cost is $750.
Tests are analyzed at a lab regulated by the state and by federal standards under the Clinical Laboratory Improvement Amendments of 1988.
The saliva is tested for GRK3 mutations linked to bipolar disorder. The results are sent to the patient's doctor, who discusses them with the patient.