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Pharma Service
Comprehensive Solutions forPharma Service
Comprehensive Solutions for
Pharma Service

As a pioneer in companion diagnostics (CDx), AmoyDx highly values our partnerships with pharmaceutical companies, and we are committed to continuously developing innovative diagnostics approaching precision medicine, delivering tailored treatments to maximize clinical benefits.From early development to regulatory approval, we offer comprehensive solutions to accelerate drug development, including drug related biomarker discovery, bespoke assay development, global assay transfer, CTA service, companion diagnostics kits development and post-marketing investigational studies.

Rx
AmoyDx
Global
Laboratory Network

US CLIA and CAP

Accredited Labs

 US  CLIA and CAP

EU CAP& ISO15189

Accredited Labs

 EU  CAP& ISO15189

Asia CAP & ISO15189

Accredited Labs

 Asia  CAP & ISO15189

We’ve built a global network of CAP accredited labs and partners to provide harmonized laboratory testing service across the world. So far, our laboratory testing service has supported 400+ clinical trials around the globe, including China, APAC, EMEA and US, and a wide range of technologies has been implemented in laboratory testing, including PCR, NGS, IHC/mIHC/Digital pathology, FISH, Sanger Sequencing, and MS.

Global
CDx Development

FDA

Food and Drug Administration

FDA

EMA

European Medicines Agency

EMA

NMPA

National Medical Products Administration

NMPA

MFDS

Ministry of Food and Drug Safety

MFDS

PMDA

Pharmaceuticals and Medical Devices Agency

PMDA

AmoyDx has extensive experience of CDx/IVD development around the globe. So far we have developed and commercially launched 70+CDx/IVD products globally, with CDx registration and regulatory submission experience in China, APAC, EMEA and US , the technologies of these CDx/IVD products are based on PCR, NGS, IHC, FISH and Sanger Sequencing.

Global
Laboratory Network

We’ve built a global network of CAP accredited labs and partners to provide harmonized laboratory testing service across the world. So far, our laboratory testing service has supported 400+ clinical trials around the globe, including China, APAC, EMEA and US, and a wide range of technologies has been implemented in laboratory testing, including PCR, NGS, IHC/mIHC/Digital pathology, FISH, Sanger Sequencing, and MS.

Global
CDx Development

AmoyDx has extensive experience of CDx/IVD development around the globe. So far we have developed and commercially launched 70+CDx/IVD products globally, with CDx registration and regulatory submission experience in China, APAC, EMEA and US , the technologies of these CDx/IVD products are based on PCR, NGS, IHC, FISH and Sanger Sequencing.

Pharma
Press Release

Global
Presence

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