Biotop-report 2012

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28

BioTOPics 44 | May 2012 

BioTOP-Report

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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29

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.

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