Theranostics, the merger between therapeutics and diagnostics, paves the path for personalized medicine. It is regarded as a tool for achieving digital health and can be considered among fourth generation technologies in pharmaceuticals.
Healthcare systems are facing tough decisions on account of ageing populations, increase in chronic diseases and depleting public finances. There is a paradigm shift toward integrating therapeutics and diagnostics rather than developing and deploying them separately. In this gradual move toward personalized medicine, companion diagnostics are an intermediate stage. The next development is the emergence of Theranostics, in which single chemical entities are developed to deliver therapy and diagnosis simultaneously.
Theranostics can be an effective tool in digital healthcare that renders specifically targeted therapy through precise and accurate diagnostic data. This aids in the early diagnosis of the disease which if undetected, could escalate to damage of major body organs. Theranostics has been successfully exploited in oncology and is now emerging as a possibility for neurological disorders such as Alzheimer’s, schizophrenia etc., cardiovascular diseases, immunological disorders, osteoporosis, diabetes, etc.
The different stages in the fabrication of theranostic devices are as follows:
Proteus Digital Health has developed the world’s first digital medicine, Proteus Discover, that consists of an ingestible sensor, a small wearable sensor patch, an application on a mobile device and a provider portal. Proteus Discover unlocks insights into patient health patterns and medication treatment effectiveness, leading to more informed healthcare decisions. The patient activates Proteus Discover by taking medication with an ingestible sensor. Once the ingestible sensor reaches the stomach, it transmits a signal to the patch worn on the torso. A digital record is sent to the patient’s mobile device and then to the Proteus cloud where healthcare providers can access it via their portal.
Keratin Biosciences has developed a microchip-based implant, a self-contained hermetically-sealed drug delivery device that is easy to implant and remove. Each implant contains 100s of micro-reservoirs, small hermetically sealed compartments, each of which can store up to 1 mg of drug. The microchip-based implant is activated by a wireless signal which triggers the micro-reservoirs to release the drug on a pre-programmed dosing schedule. The microchips are capable of delivering precisely metered quantities of molecules. The construction and placement of the microchip in a patient enables the local or regional release of drugs. With 113 patents granted and 33 patent applications, the implant has been clinically validated in human studies delivering parathyroid hormone (PTH) in osteoporosis patients and the most advanced version of the system is fully programmable via wireless communications to adjust dosing by the physician and/or patient.
ReShape Lifesciences has developed a customizable neurometabolic therapy called ReShape vBloc Therapy which is derived via a rechargeable neuroregulator that is implanted subcutaneously and attached to the vagal nerve. Proprietary bioelectronic neuroblocking technology intermittently blocks hunger signals on the vagus nerve, reducing hunger feelings that result in earlier fullness. This therapy offers patients a real weight loss alternative with less restrictions and risks.
Medtronic has received FDA approval of a new clinician programmer for use with the SynchroMedTM II, an Intrathecal Drug Delivery system. The system consists of an implantable pump that provides targeted drug delivery for chronic pain and severe spasticity. The SynchroMed II pump delivers medication directly to the fluid around the spinal cord, which provides relief at lower doses compared to oral medications.
EBR Systems Inc. has developed an implantable system for wireless tissue stimulation, with an initial focus on addressing well-recognized shortcomings in treating heart failure with Cardiac Resynchronization Therapy (CRT). The proprietary WiSE Technology is designed to eliminate the need for a lead to the left ventricle in CRT and associated complications.
A few recent patent publications have been presented below:
US application (US20170140145A1) from Netspective Communications discloses a physiological sensor implanted within a subject's body to sense contextual changes or physiological determinants.
US granted patent US9248301B2 from Koninklijke Philips NV, discloses a system for communicating information between implantable medical devices such as deep brain stimulator devices in the skull of patients, for acquiring diagnostic, therapeutic information and for general monitoring of activities of patient.
iRhythm Technologies has been granted a patent (US9597004B2) for a wearable monitor device that records cardiac data from a mammal and extracts particular features of interest, which are then transmitted and used to provide health-related information about the mammal. An extremely patient-friendly design, the Zio patch facilitates high patient compliance, requiring no maintenance or special attention. The patch enables the patient to even shower, sleep and exercise while wearing it.
Recently, a research team from Hong Kong Baptist University (HKBU) Chemistry jointly led by Professor
Ricky Wong Man-shing and Associate Professor Dr Li Hung-wing has invented a new class of multifunctional cyanine compounds that can be used for detection, imaging and thus treatment of Alzheimer's disease. They found that the cyanine compounds applied onto a "nano"-detection platform can quantify trace amounts of Alzheimer's disease related protein biomarkers present in human fluids such as cerebrospinal fluid, serum, saliva,
and urine. The compounds also serve as an imaging agent for in vivo detection and monitoring of disease progression and
understanding the disease pathogenesis as well as a drug candidate for treatment of the disease. This invention has recently been published by US patent office (US20170097340A1).
Researchers at Queensland University of Technology in collaboration with Royal Brisbane and Women’s Hospital and Mater Adult Hospital are developing a diagnostic assay based on multi-protein panel using logistic regression analysis to detect heart failure in at-risk individuals within the community using human saliva as a medium, potentially leading to a simple, safe early warning system.
Public-private partnerships in this space is encouraging such as Alacris Theranostics has an exclusive license from the Max Planck Institute for Molecular Genetics for the treatment of Graft versus Host Disease, a serious complication following bone marrow transplantation; Philips and Hologic have a global partnership agreement to provide mammography solutions for breast screening and diagnosis of women in need of care.
Combining diagnostics and therapy brings new opportunities for delivering the right treatment at the right time to each patient. However, there are major challenges that need to be addressed. Having reliable patient-specific data is essential for achieving desired results. Patient data privacy, liability and other legal concerns, as well as viable data-driven business models, are unsolved issues - one grey area is the lack of clear regulations on who is responsible for protecting patient data held and developed by third parties. An important compliance area is the intentional sharing of protected health information (PHI) with third parties, whether for data mining, research or marketing purposes.
Theranostics provides a transition from a conventional to a contemporary, personalized and precision oriented approach in medicine. It unlocks insights into patient health patterns and medication treatment effectiveness, leading to more informed healthcare decisions. From the clinician's perspective, theranostics provides a valuable tool for identifying and selecting patients with a particular molecular phenotype indicative of positive response to treatment. From an economic perspective, theranostics can lead to more cost effective and efficient drug programs, guiding pre-clinical drug development or clinical trial eligibility to help maximize the likelihood of successful outcomes.
ACKNOWLEDGMENTS: Dr John Kathi and Dr J.V. Sivaprasad Rao
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