Next Generation Personalized Diagnostics
Chronic diseases are the leading cause of death and disability nationwide, with 40% of U.S. adults having two or more chronic conditions. Studies of the Medicare population show an average of 4.1 prescriptions per patient/month with 25% using six or more prescriptions to manage concurrent medical conditions.
Between 10-30% of hospitalizations can be attributed to adverse drug events (ADEs). Much of the morbidity/mortality and costs associated with these hospital stays could be prevented by monitoring for drug interactions, dose optimization and remote follow-up after transitions of care. In the era of telemedicine, remote patient monitoring (RPM) at home and other points of care will be among the most cost-effective tools to improve outcomes and decrease costs.
Personalized Metabolic Fingerprint™ (PMF™) Device
Empiriko is developing a point-of-care (home-based testing) diagnostic platform for biomarkers and drugs. This platform empowers clinicians to optimize treatment, medication dosing and prevent adverse drug events for common clinically relevant
conditions. The PMF™ device includes a miniaturized mass spectrometer and immunochemical biochip. The device is 3D printed, highly sensitive and cost-effective.
Mass spectrometry (Mass Spec) is an industry gold standard instrument for small molecule analysis across many industries. Current Mass Spec instruments require highly skilled scientists to run and analyze data. The sample preparation is manual, and analysis takes days to weeks. In contrast, Empiriko’s fully automated, miniaturized mass spectrometer delivers test results for drug analytes in minutes. Empiriko’s initial focus is drug monitoring in clinical trials and at-risk patients at home. Eventually, Empiriko’s mass spectrometers will be licensed or sold in markets beyond life sciences and healthcare.
The PMF™ device platform includes:
Chemical analysis: Miniaturized mass spectrometry measures blood concentration levels for drug response and drug-to-drug interactions to assist clinicians in optimizing drug dosing and preventing adverse drug events.
Biologic analysis: Immunochemical biochip for biomarker detection for an array of common clinically relevant conditions.
Blood collection device and strips: The blood collection device includes fine microneedles which enable patients to comfortably draw 300-microliters of blood from the skin of their arm in a painless manner.
Test cartridges: Test cartridges include monitoring panels (e.g., drug analytes, liver, kidney, cardiac, inflammation tests and tumor markers) which are prescribed by a patient’s physician. Each cartridge is color coded by disease panel.
Test Results: The analytical engine translates the results into actionable clinical data and transmits it in real-time to a patient’s electronic medical record.
The flexibility, cost and range of applications provided by the PMFTM device dramatically extends a clinician’s reach, empowering informed clinical decision making in patients who require monitoring of complex conditions, biomarkers, and drugs from remote settings where diagnostic assessments might not otherwise be available.
This innovation which removes the need for the patient and provider to be in geographic proximity opens access to laboratory assessment and physician interpretation for underserved populations on a global scale from anywhere an internet connection is available. This clinically relevant, socially impactful, and economically disruptive model will set a new standard for next generation diagnostics at the vanguard of precision medicine.
