Unmet Medical Need

Genetic tools to aid diagnosis of mental illness

Genetic testing promises to improve diagnosis of schizophrenia, bipolar, and related disorders. Though there are well accepted psychiatric tests that are used to diagnose psychosis (schizophrenia and bipolar) such tests are, at present, imprecise. For example, schizophrenia is not a single homogeneous disease. Often patients display clinical features that are also seen in bipolar disorder, unipolar depression and obsessive-compulsive disorder. Specific genes are expected to affect specific clinical features. SureGene’s scientists and collaborators have begun unraveling parts of this mystery. Ultimately, The AssureGeneTM Test will provide psychiatrists with a biological tool to complement and enhance their clinical diagnosis thus creating better outcomes for patients. SureGene believes that The AssureGeneTM Test will be particularly valuable for pre-psychotic patients and those experiencing first episode psychosis

Pharmacogenetics (PGx) of antipsychotics

Quite possibly no other pharmaceutical category presents a greater unmet medical need for a PGx test than atypical antipsychotics. Studies have shown the 74% of time the first drug prescribed fails to work. Indeed, on average, physicians must try 3 drugs before finding one that works with that particular patient.

 This therapeutic gap demonstrates an powerful need for a PGx test. Even a relatively minor improvement of efficacy rates could yield multi-billion dollar annual savings to the US healthcare system. Moreover, as the test is taken once per lifetime the savings to the healthcare system will continue to accrue over the lifetime of the patient. At the individual patient level, the ability to chose the right drug for the right patient at the right time will provide immeasurable improvement to the overall quality of life for patients and their care-givers.

Predictive Medicine for psychosis

In addition, The AssureGeneTM Test can provide risk assessment for individuals with a family history of psychosis. Much of the uncertainty and accompanying anxiety for families with a history of schizophrenia or bipolar can be eliminated by knowing the specific genetic risk factors involved. For example, schizophrenia does not present until the second or third decade of life, and siblings of schizophrenics are about 10-fold more likely, on average, than the population at large to develop the disease. Naturally, parents with one affected child are concerned about the (future) health of their other children. Further, even though siblings may not themselves develop the disease, their children and grandchildren are at increased risk. Such siblings are in need of valid genetic risk assessment.