Bruker Daltonics obtains South Korean registration of its Autoflex II Maldi-tof mass spectrometer as a Class I medical device for in-vitro diagnostics (IVD)
Bruker Daltonics reports that it has obtained registration of its Autoflex II Maldi-tof mass spectrometers as Class I medical devices with the Korea Food and Drug Administration.
Maldi-tof mass spectrometry is increasingly being applied to the areas of clinical proteomics, functional genomics and biomarker discovery as a clinical research tool.
With recent advances, usage of Maldi-tof in in-vitro diagnostics (IVD) applications has become very promising.
Bruker Daltonics has now taken what it says is the important step of registering its Autoflex II systems as medical devices in the Republic of Korea, to facilitate regulatory approval of novel mass-spectrometry based IVD methods by its Korean customers.
Bruker Daltonics has developed ClinProt for peptide and protein biomarker profiling, discovery, identification and validation from body fluids or tissue samples.
ClinProt offers an unparalleled combination of cost-effective scalable sample preparation using magnetic bead arrays, high-performance Maldi-tof and Tof/Tof detection, and advanced analysis and visualisation software.
Autoflex II Maldi-tof(/Tof) mass spectrometers are a key part of ClinProt.
Offering throughput up to thousands of samples per day, Autoflex II is described as a high performance 24/7 system for advanced biomarker discovery and identification, functional genomics and high- success expression proteomics.
Following registration as a Class I medical device, Autoflex II is now being used by GeneMatrix in Korea, an emerging molecular diagnostics company in pharmacogenomics, for molecular diagnostics applications, including the diagnosis of Lamivudine resistant hepatitis B virus (HBV), hepatitis C virus (HCV) genotyping and human papilloma virus (HPV) genotyping, based on GeneMatrix's proprietary restriction fragment mass polymorphism (RFMP) technology.
GeneMatrix's testing services are already in use by a number of major medical centres and university hospitals in the Republic of Korea.
Clive Seymour, vice president for Asia-Pacific at Bruker Daltonics, commented: "Our continuing development of the ClinProt solution towards IVD applications is greatly accelerated by the acceptance by the South Korean authorities of our Autoflex II systems as Class I medical devices.
"It gives the clinical research community the confidence to proceed with their mass-spec based IVD research in the knowledge that our Maldi-tof systems will be accepted for IVD use in the clinical environment".
ClinProt applications are for research use only (RUO).
