Diagnostics and IVDs
We have the track record in IVDs that is second to none. Whether it’s a multi-gene assay from a next-gen sequencer, a companion diagnostic, artificial intelligence for automated pathology image analysis, traditional laboratory ELISA or Point of Care rapid tests, we have the global experience to support you.
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Artificial Intelligence
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Companion diagnostics
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Genomics and proteomics
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Home use tests
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Molecular diagnostics
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Laboratory tests
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Point of care rapid tests
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Software as medical device
Comprehensive Diagnostic Capabilities with all Types of Biomarkers
DNA
RNA
Protein
Cell
Tissue
Our response to COVID-19
Our team is ideally suited to support Emergency Use Applications at a global scale. We are up to speed in a fast-moving world: through detailed, current understanding of emergency regulatory processes, backed by strong relationships and expertise built over decades.
We support clients through a streamlined, staged process:
Express, objective review of your product and its international regulatory status and evidence base
Assessment of optimal pathway – including optimal positioning and eligibility for expedited processing or exemption
Rapid applications to regulators
Real time support to expedited regulatory reviews with fast global communications in any time zone