Digital Healthcare - Theranostics as a Tool

Image Courtesy: Medgadget

INTRODUCTION
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. It has been successfully exploited in oncology and is now
emerging as a possibility for neurological disorders such as Alzheimer’s, Schizophrenia, Osteoporosis,
Diabetes, Cardiovascular diseases, Immunological disorders, etc.

FABRICATION OF THERANOSTICS DEVICES

The different stages in the fabrication of theranostic devices are as follows:

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1. Development of diagnostic molecules: Diagnostic molecules, such as
biomarkers, aptamers, monoclonal antibodies, peptides, etc., that specifically
recognize the biological variations due to the onset of disease are identified and
fine-tuned according to the target disease.

2. Selection of therapeutic agents: Based on specific disease being

targeted, therapeutics such as drugs, DNA, etc., are chosen.

3. Design of suitable carriers: Nanocarriers, such as polymeric

nanoparticles, liposomes, metal nanoparticles, carbon nanomaterials
etc., are decorated with diagnostic and therapeutic molecules which
help in delivering the cargo molecules to the target cells/tissue without
affecting other neighboring cells.

4. Fabrication of nanodevices: Nanocarriers loaded with theranostic

molecules are embedded in nanodevices such as MEMS, NEMS etc. for sensing
and estimating biological components. These nanodevices are implanted in humans
and the physiological information is communicated through wireless system.

5. Integration with patient care center: The implanted device is connected to

the patient care center where clinicians are able to monitor the patient condition by retrieving reports
thereby customizing therapy.

RECENT DEVELOPMENTS
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 which on reaching the
stomach, 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.

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ReShape Lifesciences has developed a customizable
neurometabolic therapy called ReShape vBloc Therapy
which is derived via a rechargeable neuroregulator that is
implanted subcutaneously and is 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
(From left) Professor Ricky Wong Man-
vivo detection and monitoring of disease progression and
shing and Dr Li Hung-wing

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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.

CHALLENGES
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.

CONCLUSION
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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