We provide partnerships from assay development to regulatory-approved tests on a global market. Our dedicated teams of experts caters to your success in Precision Medicine.
Next-Generation Sequencing – assays and expertise that boost CDx development
We work in close collaboration with our pharmaceutical partners, providing solutions for all stages of CDx development – from biomarker discovery through to commercialization.
The Oncomine next-generation sequencing assays, for example, are multi-biomarker assays that allow for concurrent analysis of DNA and RNA in one workflow, enabling simultaneous detection of single nucleotide variants, indels, copy number variants, and gene fusions. Designed for use with the Ion PGM system, the Oncomine assays utilize Ion AmpliSeq technology with uniquely low sample input requirements, enabling highly accurate and reproducible sequence analysis of a larger range of tumor samples, including small biopsies and fine needle aspirates. These unique next generation sequencing assays can be used to support multiple oncology drug and companion diagnostics development programs.
*For Research Use Only. Not for use in diagnostic procedures.
Customized ImmunoAssays on IVD Platforms – fast development with full service support
Thermo Fisher Scientific has an abundance of assay development expertise and tests tailored for your needs. Developing a customized immunoassay on one of our automated IVD platforms is well within our capabilities, and our range of standardized reagents ensures excellent reproducibility and accuracy.
Efficient processes and specialized staff assure fast development and high-performance on a wide range of platforms. Our products, services and expertise are based on many years R&D in immunology and assay development. With extensive manufacturing capabilities, regulatory experience, certified analysis laboratories and a global supply chain, we can support you all the way from R&D assay development to post-market diagnostics.
ImmunoCAP® ADA Bridging Assay
Immunogenicity Testing – customized assays on automated IVD platforms
Monitoring Anti-Drug Antibodies (ADAs) is critical for ensuring safe and efficient administration of biotherapeutics. The key analytical challenge is to measure very low concentrations of ADAs in the presence of soluble drug, as well as ADAs of different isotypes. Once again, we have the products and skills to help you meet this challenge.
ImmunoCAP® assay plays a central role in this process. By facilitating the development of customized research-use-only assays on an automated IVD platform supported with standardized reagents, it yields the performance, stability and reproducibility essential for you to make reliable analyses.
We can help detect ADAs in screening assays and characterize the antibody isotype (IgG, IgE, IgG4, IgM and IgA) on the same solid phase. What’s more, our standard reagents are evolved from the development of clinical routine assays and subjected to regulatory approval, which shortens the development time of an assay intended for use in clinical trials.
Anti-microbial Testing – customized products developed to strict quality requirements
Fighting anti-microbial resistance and improving patient care takes more than a standard solution. Thermo Fisher Scientific offers the widest range of testing options, from pathogen identification and antibiotics susceptibility to the diagnosis of bacterial infection and sepsis in patients, combined with a team of experts ready to manage the process for you. Their skills and commitment allow you to focus on doing the science, making it easier for you to do your job and thus improve patient care faster.
Thermo Scientific pharmaceutical development team provides custom Thermo Scientific™ Sensititre™ MIC (minimum inhibitory concentration) plates to support pharmaceutical companies performing clinical drug trials for FDA submissions. We also supply custom plates and ancillaries for new compound development and surveillance testing.
Our specialists are skilled in every aspect of clinical trial management, including early stage planning and working with difficult compounds. A partnership with us ensures you enjoy a confidential and efficient drug development and clinical trial process. Furthermore, in managing these processes, we are able to put your newly-approved drug on one of our standard or custom Sensititre test formats.
Maximize Your Testing Options
- The largest and most up-to-date selections of anti-microbials and anti-fungals.
- Each order is manufactured to your specifications and adheres to strict Clinical and Laboratory Standards Institute (CLSI) and ISO guidelines.
- Batch sizes are flexible, either as frozen microbroth dilution or dried formats.
- We can also coordinate comparative validation studies for the CLSI and FDA guidelines. Testing CLSI frozen reference method versus dried plates offers pharmaceutical companies a simpler, more user-friendly solution to Phase II and Phase III clinical trial testing.
We will also co-promote the drug with you on launch, assuring access to clinical laboratories immediately after approval.
Autoimmune Disease Testing – broad biomarker portfolio delivers great clinical value
The EliA enzyme immunoassay is well on its way to becoming the new gold standard for measuring autoantibodies in the diagnosis of autoimmune diseases.
The current EliA product portfolio comprises 44 of the most common routine autoimmunity biomarkers. Over 20 more are in development. Furthermore, all routine analytes run on a fully-automated and closed instrument platform that offers great flexibility in terms of throughput. New tests are easy to adapt to laboratory routines, which further contributes to increased convenience and better cost-efficiency.
EliA assays deliver excellent clinical value. Their high specificity results in fewer false-positive reports, while high sensitivity gives less false negatives. End-user laboratories also benefit from a comprehensive support package that includes a global Quality Club, an autoimmune disease application service, specialized symposia and much more.
Unrivalled Global Coverage and Influence – reaching out everywhere
Our track record of successfully bringing a variety of platforms to clinical markets across the globe is well proven. Exactly the same can be said of our ability to introduce diagnostic tests. And once launched, our established channels and effective global coverage continue to drive awareness and ensure availability. Finally, our invaluable network of key opinion leaders helps spread information and encourage early adoption in strategic markets.
Thermo Fisher Scientific’s Global Regulatory Staff has demonstrated experience in successfully supporting, maintaining and routinely securing registration for products in the US, EU, and Pac-Asia regions as well as South America, Canada, Australia, Russia, and S. Korea. The Regulatory staff is experienced in the processes for obtaining and maintaining CE/IVD certification, US FDA requirements such as PMA and currently hold over 800 FDA clearances for 510(k) products. The diverse regulatory background of the over 80 Regulatory professionals across the US, EU, APAC and Latin America encompasses experience in various types of medical devices, diagnostics, clinical trials and companion diagnostics. Current CDx programs include test development based on PCR, NGS and immunoassay formats, and as such Thermo Fisher Scientific can provide regulatory competencies in supporting the design and execution of studies, establishing direct links to regulatory authorities, and creating regulatory documentation to meet the various requirements of country-specific registration pathways across multiple platforms.
Health Economics Expertise – no diagnostics partnership is complete without it
Evidence to support funding for diagnostics is increasingly requested from national and commercial healthcare providers. As an experienced diagnostics manufacturer, Thermo Fisher Scientific is ideally placed to develop and communicate the cost effectiveness analyses required for adoption by the health system. Furthermore, close collaboration between diagnostics and treatment developers enables unified messaging to all stakeholders, which can be crucial for early market access dialogs. At Thermo Fisher Scientific, health economics expertise is not just an important part of our partnering offer – it is essential.
Alliance Management – building winning combinations together
Thermo Fisher Scientific’s dedicated Alliance Management teams work closely with Pharma companies to build a winning collaboration during the entire project. From marker to market, we focus on tailored solutions that fit both our organizations and enable effective communication between them. Furthermore, our partnering experience extends to third-party collaborations as well.
Alliance Management drives strategic, operational and cultural alignments to meet co-determined objectives, manages partnership governance, and ensures compliance with all contractual governance provisions.
Getting drug development and companion diagnostics / biomarker development to go hand-in-hand requires special coordination skills. Our in-depth knowledge of both allows us to excel; we understand the different processes and contribute to the greater common good.
Our alliance management tools, performance metrics and methodologies are all in place. Everything to facilitate collaboration and ensure that project team members can truly focus on their work exists. We look forward to partnering with you!