Cogstate (ASX:CGS) has received notification from the FDA its submission for the COGNIGRAM cognitive assessment system has been reviewed by the Center for Devices and Radiological Health and found to meet the requirements for commercial distribution in the US.
The COGNIGRAM system is a digital cognitive assessment tool with self-administered assessment that can be completed both in-clinic and at-home. It is for prescription use, and is intended to aid healthcare professionals with an objective measurement of cognition for use in individuals aged 6 - 99 years old.
The system can be used to assess cognition on a single occasion or cognitive change over periodic assessments.
“After more than fifteen years of intense efforts in supporting academic research and pharmaceutical clinical trials around the world, Cogstate is excited to enter the US market for cognitive assessment on the front lines of clinical practice,” commented Frank Cheng, president of Cogstate Healthcare. “We look forward to bringing the proven and widely-published COGNIGRAM technology into the healthcare ecosystem to benefit an exponentially larger pool of patients.”
“Many primary care physicians (General Practitioners) lack the tools and training to conduct rapid, objective cognitive assessments. The launch of the COGNIGRAM system will provide doctors with a rapid, scalable, standardised tool for detection of cognitive impairment and decline. The fact that COGNIGRAM requires no special equipment and can be administered in-clinic or online, in the comfort of a patient’s own home, makes COGNIGRAM an adaptable solution for the primary care market,” said Brad O’Connor, CEO of Cogstate.
Factors that may affect an individual’s cognition include the presence of mild cognitive impairment (MCI), Alzheimer’s disease, concussion, head injury, major depressive disorder, HIV related dementia, schizophrenia, attention deficit hyperactivity disorder (ADHD), multiple sclerosis, Parkinson’s disease, the effects of medication or surgery, as well as a variety of psychological states.
Cogstate said it expects to begin commercialisation of the COGNIGRAM system in the US before 31 December 2017, with initial commercialisation efforts focused on hospitals, physician practices, elder care organizations, schools and sports teams.