Recent funding has launched Stemina Biomarker Discovery into what will be their largest autism spectrum disorder clinical study. In September of 2015, the company was awarded a $2.7 million grant from the National Institute of Mental Health. The Nancy Lurie Marks Family Foundation contributed an additional $2.3 million investment. The study will be known as the Children’s Autism Metabolome Project, or “CAMP” that will involve 1,500 children from age 18 months to 4 years administered at six sites within the U.S. One third of the participants have been diagnosed with autism, another third with other neurodevelopment disorders and the final third who appear to have normal development.
In current autism research, most involve blood tests that study gene expression; however, Stemina’s technology measures metabolites in the blood. The company foresees that their technology can conclusively identify two subgroups within the autism spectrum and discover additional biomarkers. These subgroups are found through changes in the gastrointestinal tract and another in the urea cycle. Currently Stemina has an accuracy rate of 80%. This autism test would be Stemina’s first diagnostic product. By diagnosing autism earlier, it will allow treatments to be tailored the each patient sooner. The company will follow with testing for neurological disorders such as schizophrenia and depression at a later date.
This same technology is being used by the company as a revenue-generating avenue. Using the stem cell technology to screen for possible harmful compounds to developing human embryos. Testing is performed on household cleaning products, pesticides, and consumer products. This product, devTOX, was launched in March 2009.
Stemina Biomarker Discovery began from the work of Gabriela Cezar, DVM, PhD at the University of Wisconsin in 2006. The company was founded by Elizabeth Donley, JD, MBA, MS who is the CEO. The company is currently looking to raise an additional $3 million to allow the CAMP study to expand to additional facilities. The company is making a presence in the Boston area by expanding to the Cambridge Innovation Center in Cambridge, MA in hopes of connecting to new investors. Since the company’s founding they have raised over $15 million.