Bruker Daltonics Obtains South Korean Registration of Autoflex II
News Aug 11, 2005
Bruker Daltonics Inc. has announced 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 applied to the areas of clinical proteomics, functional genomics and biomarker discovery as a clinical research tool.
According to Bruker, with recent advances, usage of MALDI-TOF in in-vitro diagnostics (IVD) applications has become very promising.
Bruker Daltonics has taken the step of registering its autoflex II systems as medical devices in the Republic of Korea, to facilitate regulatory approval of mass-spectrometry based IVD methods by its Korean customers.
Bruker Daltonics has developed the innovative ClinProt™ solution for peptide and protein biomarker profiling, discovery, identification and validation from body fluids or tissue samples.
The ClinProt solution is designed to offer an unparalleled combination of scalable sample preparation using magnetic bead arrays, high-performance MALDI-TOF and TOF/TOF detection, and advanced analysis and visualization software.
The Company's autoflex II MALDI-TOF mass spectrometers are a key part of the ClinProt solution.
Bruker offers that autoflex II is 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 used by GeneMatrix Inc. in Korea, including the diagnosis of Lamivudine resistant Hepatitis B virus (HBV), Hepatitis C virus (HCV) genotyping and Human Papilloma Virus (HPV) genotyping, based on GeneMatrix' proprietary Restriction Fragment Mass Polymorphism (RFMP™) technology.
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."
He adds, "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."