De Novo, A New Day

By Jack Cosentino

I have spoken of the way Medibio’s objective diagnosis and monitoring of mental illness will change the landscape of mental health worldwide. Today marks another milestone in our progress toward bringing Medibio technology to the millions of people who need and deserve better care. I’m proud to say we have just submitted the De Novo application to the FDA, which means we are categorized as a truly innovative technology with no substantially similar precedent. Our science has been tested and re-tested by leading research institutions around the world to get us to this point. My hope is that the breakthrough in technology that Medibio represents will very soon conquer the many obstacles to effective mental health care that have cost and compromised so many lives, and bring unprecedented change in the world.

Soon those who might have received an inaccurate diagnosis by well-meaning doctors due to the inherent lack of precision in subjective clinical practice will have their illness identified with more confidence by those same practitioners. No longer will a doctor and patient spend months or years sorting out exactly what illness or set of illnesses the patient has. No longer will an educated guess be the basis of prescribing treatment. No longer will patient self-reporting and a doctor’s subjective appraisal be solely relied upon to assess progress. Now subtle positive or negative changes can be observed quantitatively, probably before the patient would be able to consciously notice, and treatment maintained or altered accordingly.

Additionally, there are many who would have gone undiagnosed entirely and without treatment because they are not fully aware that a mental illness is affecting their lives. They will soon be tested as part of general health care or as part of their company’s partnership with Medibio in the Corporate Health program. They will find out they have a problem instead of silently suffering without knowing why. Many, perhaps millions of those people will be told they have options to improve their lives in ways they hadn’t imagined.

As part of the ongoing reframing of mental illness away from character and personality-based attribution toward genetic and other biological causes, Medibio’s innovation will serve to lessen the unfair stigma attached to depression, anxiety, and other diseases. I believe we can make a historical contribution to removing the burdens of shame and fear — two things that ruin and take lives unnecessarily when those suffering don’t seek help.

Now that we have an objective view of the physical manifestation of these illnesses, insurance providers will have to place mental illness on par with every other affliction, and provide equal coverage to those who have until now been told the problem they or their loved ones suffer from isn’t real enough to warrant proper medical attention.

The approval we anticipate from the FDA to bring our technology to market will change lives and save lives, and will mark a breakthrough moment in the history of medicine. Medibio has opened a window into the future of mental health. This is a big day for us. Many have played a role in our reaching this exciting stage of the journey, and I warmly and sincerely thank all of you for being part of Medibio’s success. Your efforts will affect the lives of millions for generations to come. Be Well.