We are seeking one or more partners in the biopharmaceutical field.

Potential New Drug Market — Young people experiencing first-time psychosis in the U.S. typically have behavioral changes and psychosis spectrum symptoms for more than a year before receiving a diagnosis (RAISE Study-NIMH). Laguna Diagnostics believes that our assays can identify these subjects before their first psychosis episode. As part of our validation clinical trial study, we are designing a protocol to test that our methodology allows for the objective diagnoses of SZ and BD with the potential to detect these conditions one to two years before a first psychotic episode (potential new drug market). Can we find a drug to prevent the first psychotic episode? Our proprietary rapid blood tests offer fast and more accurate diagnoses, enabling earlier intervention and reducing costs, leading to improved quality of life for patients. Our test results are generally returned rapidly to the ordering physician, usually within days. Research has shown that the earlier these psychiatric disorders are diagnosed and treated, the better the patient outcome. Early detection of a mental disorder also enables rapid interventions, especially in younger populations, with significant potential for benefits to the individual, family, and society.

Innovative Analytics (IA) is a Contract Research Organization (CRO) based in Kalamazoo, Michigan. It provides expert Data Management, Statistical, and Medical Writing Services, from protocol design to study report writing.

Laguna Diagnostics worked with Innovative Analytics on our pivotal clinical trial to formulate and perform classification analysis and test-retest method development. Laguna Diagnostics’ initial clinical trial was conducted with 90 subjects at three-time points and demonstrated that our RNA gene panel diagnoses schizophrenia and bipolar disorder from healthy controls with high selectivity and high sensitivity (both over 95%), plus effectively differentiated between SZ and BD patients.

Jim Dancy, BSE, MBA, President, CEO – As the leader of Innovative Analytics, Jim is responsible for advancing the company’s focus on exceptional service. Over the years, he has developed an experienced team committed to personal attention and world-class quality. He is also responsible for business development. Jim co-founded IA in 2003 with Patty Ruppel (retired and available as a consultant). Before Innovative Analytics, Jim held several critical positions in data management, including Director of Clinical Database Operations (Pharmacia) and Director of Experimental Medicine Informatics (Pfizer). While at Pfizer, he implemented a database to support clinical biomarker analysis, which earned a “Best Practices” award in 2003. Jim holds an engineering degree from the University of Michigan and an MBA from Oklahoma University. He achieved Certified Quality Engineer (CQE) status through the American Society for Quality (ASQ).