Bruker Daltonics has registered its autoflex II MALDI-TOF mass spectrometers as class I medical devices with the Korea Food and Drug Administration with an eye on eventually selling the instruments for use in the molecular diagnostics market.
Although the autoflex instruments are currently sold for research use only, registering them as class I medical devices "will help our customers get regulatory approval for their own mass spectrometry-based [in vitro diagnostic] applications," according to Wolfgang Pusch, director of clinical proteomics and biomarker analysis products for Bremen, Germany-based Bruker Daltonik.
He added, "Several of our customers have very promising mass spectrometry-based assays for potential new IVD applications. To get approval for their respective tests from the authorities, it is mandatory or at least very helpful to have the instrument itself already approved as a medical device."
The registration also puts Bruker Daltonics on a path to expand its mass spec business from research laboratories to commercial laboratories and hospitals.
"Eventual approval of Genematrix's technology as an IVD test will further stimulate instrument sales for Bruker Daltonics to major Korean hospitals or service providers. For our main market of clinical proteomics, we also believe that this approval will stimulate the market for our ClinProt products further in South Korea."
The mass spectrometers are already being used by GeneMatrix, a South Korean biotech firm, for molecular diagnostic applications, which the company offers to medical centers and university hospitals in the country. According to Pusch, GeneMatrix has developed proprietary assays that can detect various viruses including hepatitis C virus and lamivudine-resistant hepatitis B virus, as well as tissue genotyping. In addition, the company's MALDI-TOF mass spectrometry-based tests "are already accepted by Korean clinicians," he told BioCommerce Week in an e-mail interview this week.
"Eventual approval of GeneMatrix's technology as an IVD test will further stimulate instrument sales for Bruker Daltonics to major Korean hospitals or service providers," he said. "For our main market of clinical proteomics, we also believe that this approval will stimulate the market for our ClinProt products further in South Korea."
The autoflex II instruments are part of Bruker's ClinProt integrated system for peptide and protein biomarker profiling.
Pusch said the firm wanted to send a clear signal to its customers that it has decided to bring mass spec into the clinical laboratory, and this decision would have significant implications for current research applications.
"Customers in the research phase of projects with the ultimate potential to generate new assays for use in clinical diagnostics have the option to choose an instrument that will be suitable for future diagnostic applications, as well," he said. "That means, if they succeed, they will not have to change the instrument platform in the end."
Registration of the autoflex also means that researchers developing homebrew assays would have a higher level of confidence in the instrument's reliability, he said.
There is a growing consensus in the clinical research community that mass spectrometry has significant potential as a future diagnostic tool for many different applications. And Bruker believes it is the first firm to register a MALDI-TOF and TOF/TOF system as a medical device worldwide.
However, Pusch noted that triple-quadrupole mass spec-based IVD tests for newborn screening have been registered in several countries, and lower-performance SELDI-TOF technology has previously been registered in China for IVD applications.
Mass spec instrument manufacturers, as well as peptide and protein sample prep technology firms, have been eyeing participation in the emerging molecular diagnostics market. Several firms in the BioCommerce Week Index, including Qiagen and Invitrogen, have made a series of acquisitions over the past year with that opportunity in mind (see BioCommerce Week 8/4/2005 and 6/23/2005).
How soon mass spec instruments will be used in molecular diagnostics depends on the application, according to Pusch. He said well-defined applications, such as GeneMatrix's tests, could be used as a mass spec-based IVD "quite soon."
Pusch said Bruker's global strategy is to get approval of the ClinProt products, including the respective mass spectrometers, as medical devices or IVD accessories, in several countries. The firm has begun speaking with regulators about registering the devices in additional Asian countries and Russia, he said. In addition, Bruker has started internal projects with a goal of obtaining approvals in the European Union, Canada, and the US.
Bruker "will look for appropriate partners with the necessary expertise for the marketing and selling of diagnostic kits" for any upcoming dedicated IVD application of the ClinProt product suite, according to Pusch. "A strategic partnership with a larger IVD or medical company could be an option for us," he added.
Beyond diagnostic applications, the mass spec instruments could be used for microbial identification, an upcoming field that has not yet been discussed much by the clinical research community, according to Pusch. "This is a robust methodology which allows the identification of unknown bacterial strains without any a priori assumptions, which are necessary for many classical microbiological procedures," he said.
— Edward Winnick ([email protected])