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Theranostics
A New Approach in Individualized Healthcare
for the Future
The term theranostics refers the increasing integration of diagnostics and therapy with the aim of providing
the right therapy for the right patient at the right point in time. The implementation of such a concept requires,
above all, determination of the genetic predisposition of the patient, characterization of the stage of the
disease and monitoring of the progress of healing. In vitro-diagnostic procedures and molecular imaging will
increasingly interlock in this approach in the future.
Companion diagnostics and personalized medicine
This “personalization” of medicine has become one of the prime
strategic goals in health research. It is based on the insight that
different patients with the same diagnosis respond differently to
the same treatment. To choose the “right therapy”, it is therefore
necessary first to evaluate a therapy potentially to be applied by
reference to the individual patient and assess its effectiveness,
tolerability, safety and dosage. This is done using predictive di-
agnostic tests which determine the individual features of the pa-
tient at the genetic, molecular or cellular level.
The use of such companion diagnostics as part of the therapeutic
process permits stratifying patients with the same diagnosis and
selecting them accordingly to ensure that each patient receives
the most effective customised therapy possible. Personalized
medicine consequently comprises defined tandems of medicines
and tests to demonstrate effectiveness of the respective therapy.
The key drivers behind this trend are, above all, the need to im-
prove medical treatment (healthcare pressure/benefit-risk ratio),
economic pressure (benefit-cost ratio) and the development of
new technologies which continuously expand the range of diag-
nostic capabilities available.
The impact of new technologies on the development
of personalized medicine
Diagnostics for personalized medicine require suitable biomark-
ers as the foundation for patient-specific therapy selection. The
sequencing of the human genome and the continuously pro-
gressing molecular differentiation it has opened up, above all as
regards oncological and immunological diseases, permits predic-
tive statements about the possible progress of therapy based
on an analysis of the patient’s genetic makeup. Next generation
sequencing, bioinformatics and data mining are expanding the
range of available markers continuously. The Max Planck Insti-
tute for Molecular Genetics, the spin-off company Alacris Ther-
anostics GmbH and Bayer Healthcare are eminent players in this
field in Berlin-Brandenburg in the context of the European re-
search project OncoTrack which focuses on cancer of the colon.
The miniaturization and parallelization of analytical technologies
(micro-arrays, beads) and new multiplex processes such as those
developed by Scienion AG (Berlin) and the Fraunhofer Institute
for Biomedical Engineering (IBMT) in Potsdam are bringing the
new assays into routine clinical laboratory practice.
Oncology – key driver for diagnostic-based therapy
The approval of Trastuzumab in the United States in 1998, based
on the genetic proof of the overexpression of the HER2 gene
in breast cancer, marked the first step in the personalization of
oncotherapy. Since then, further genetic tests have been intro-
duced into clinical practice, including K-RAS (colorectal cancer)
and EGFR mutation analyses (lung cancer). The approval of new
and expensive medicinal substances such as biologicals will be
conditional in future on the availability of mandatory diagnostic
pre-tests.
In Germany, 20 medicines are currently approved for person-
alised medicine, 16 of them for oncotherapy and the rest for the
treatment of HIV (2), epilepsy (1) and transplantation prognosis
(1). The co-development of diagnostic and therapeutic products
presents the pharmaceutical industry with a new strategic chal-
lenge and is opening up new business fields for innovative SMEs
as developers of in vitro-diagnostics.
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BioTOPics 44 | May 2012
Theranostics
BioTOP-Report
In vitro-diagnostics in Berlin-Brandenburg
In Berlin-Brandenburg, some 80 SMEs and about 20 research
facilities provide the entire value chain for in vitro-diagnostics –
from biomarker identification and validation to the development
of new technologies for the production of marketable innovative
products, above all for immunology, oncology and the diagnosis
of infectious diseases.
As one of Europe’s largest university hospitals, Charité – Univer-
sitätsmedizin Berlin provides outstanding conditions for the im-
plementation of clinical trials to validate new biomarkers. Some
30 regional companies specialise in the development of molecu-
lar diagnostics for use in screening, prognosis and monitoring,
and some of them are also engaged in the development of com-
panion diagnostics for oncotherapy.
Current developments include assays for the therapy of cervi-
cal cancer under anti-angiogenesis treatment (Celltrend GmbH,
Luckenwalde), for the use of Cetuximab in colorectal cancer
therapy (Signature DIAGNOSTICS GmbH, Potsdam), the develop-
ment of mathematical models for the implementation of “virtual”
clinical studies and the discovery of new markers in colon and
pancreas cancer therapy (Alacris Theranostics GmbH/Berlin).
PD Dr. Bodo Lange
CEO
Alacris
Theranostics GmbH
Berlin
Personalised healthcare is currently undergoing a revolution-
ary development as technology advancement permits now to
analyse a patient's genome with increasing speed at continu-
ously falling costs. Alacris Theranostics is applying a combi-
nation of next generation sequencing and systems biology
modelling to develop new methods for optimised personal-
ized treatment of cancer patients. The Berlin-Brandenburg
academic research and biotech network provides an excellent
environment for such developments.