An unrivalled portfolio for
diagnostics partnering
We realize
the power of personalized medicine
Diagnostics partnering. Fast development, manufacture and commercialization of
diagnostic products is receiving greater attention than ever before. And the reason why
is not hard to discern – personalized medicine. But co-registering and co-launching a
new companion diagnostic with a therapeutic drug, or developing an assay to monitor
efficacy and dosing, requires a huge range of capabilities.
Few companies have what is needed. We do.
From initial feasibility studies to worldwide clinical use, we have the partnering skills
and resources to help pharmaceutical companies succeed. Our enabling technology
platforms and scientific services are at your disposal.
One Partner – Multiple Options
Biomarker
Discovery & Development
PRECLINICAL
Biomarker Disc. & Dev.
Next-Gen Seq
Mass Spec
IVD/CDx Development
Genomic tests
IHC
Immunoassays
Microbiological tests
CLIA Labs
Regulatory Support
Sample handling
& Biobanking
Health Economics & Reimbursement
Manufacturing
Commercialization
CDx / IVD
Development
CLINICAL
Commercialization
POST-MARKET
Biomarker
Discovery & Development
PRECLINICAL
BIOMARKER
DISCOVERY & DEVELOPMENT
CDx / IVD
Development
CLINICAL
COMPANION DIAGNOSTICS
Commercialization
POST-MARKET
CDx / LDT
OR
BIOMARKER
DISCOVERY & DEVELOPMENT
OTHER IVD DEVELOPMENT
TDM – ADA – AST – HLA
IVD / LDT
From marker to market
Biomarker discovery and validation. Access the world’s
largest collection of peer-reviewed, curated cancer genomics plus
an extensive array of platforms. Our Next-generation Sequencing,
together with an unequivocal portfolio for prote­omics mass
spectrometry, accelerates your biomarker discovery and validation.
Sample logistics and biobanking. We operate the world’s
largest Global Bio Repository. Serving academia, government
and industry, we provide complete logistics for over two million
samples per year. We package new therapeutics and diagnostics.
And we take care of patient sample logistics during trials.
Genomic tests. Our complete tool kit for molecular diagnostic
assay test development helps compress development timelines
and maximize return on investment. We deliver the right products,
at the right time, manu­factured with the right quality. All backed
up by first-class service and support.
Health economics expertise. Demonstrating the added value
of your test to the patient and healthcare system is an essential
yet complex task. From generating evidence for core Health
Technology Assessment domains to executing reimbursement
submissions, our team of experts supports you all the way.
ImmunoAssays. Rapid immunoassay development and
prototyping on major IVD instrument platforms speeds the
measurement of drugs and biomarkers. Our turnkey solutions,
spanning raw material to commercialization, comply fully with
medical device requirements. From PoC to multiplexing and
high-throughput automation, we enjoy strong relationships with
major commercial laboratories.
Global regulatory capabilities. Any diagnostics collaboration
requires broad regulatory competence across a range of
geographies and activities, e.g. clinical trials. We possess the
full spectrum of skills for complying with requirements, creating
documentation, establishing contact with authorities, and
streamlining interaction with them.
Immunohistochemistry. Our IHC portfolio includes assay
kit development and antibody production. We also have the
experience to quickly move validated assays to clinical use.
Regulatory submissions and international product registration
are part of the service.
Microbiology. Used in over 3 000 labs worldwide, our microbial
detection system is today’s gold standard for susceptibility and
identification tests. Its single platform shortens test development
times. Regulatory clearance plus a highly experienced support
team are further key attributes.
Manufacturing and commercialization. We have a proven
track record of successfully bringing a variety of platforms to
clinical markets across the globe, and of introducing approved
tests. Established channels and effective global coverage drive
awareness and ensure availability. Finally, our invaluable network of
key opinion leaders is a major resource for spreading information
and encouraging early adoption.
Looking for
a strong partner with global reach?
Already the world-leader in serving life science, we dedicate our considerable resources to
accelerating the development of personalized medicine. We are convinced that personalized
therapeutic interventions will change the way healthcare is practiced and managed.
We share your vision.
However, targeting the right patient with the right treatment also requires a companion
diagnostic. Our portfolio spans next-generation sequencing, mass spectrometry, immunogenicity assessment and therapeutic drug monitoring – all essential for realizing this goal.
We also combine full manufacturing capabilities with in-depth regulatory expertise plus
supply and marketing chains in more than fifty countries worldwide.
This global reach plus broad array of key technologies and know-how is unmatched.
And it’s available to you via active alliance management.
We are your perfect diagnostics partner. Let’s talk.
For more information, please contact companion.diagnostics@thermofisher.com or +1 919 889 4414