Proteome Sciences last week presented data on eight protein biomarker assays it developed through its participation in the European Commission’s Sens-it-iv initiative, a project aimed at devising in vitro alternatives to animal tests to determine skin or respiratory sensitivity to allergens in items including cosmetics, detergents, and other consumer products.
The assays, which use Proteome Sciences’ Tandem Mass Tagging technology combined with selected-reaction monitoring mass spectrometry, “cover a range of biological pathways" activated by exposure to various allergenic compounds, Ian Pike, chief operating officer of Proteome Sciences, told ProteoMonitor.
The eight proteins targeted by the assays are part of a larger 20-protein panel the company selected from an original list of 135 regulated proteins. According to Pike, it intends to develop assays to the remaining 12 proteins with the ultimate goal of building a panel that can be used to determine, for any unknown compound, "whether it’s allergenic, an irritant, or completely benign.”
The company hopes to bring such a panel to market in the first or second quarter of 2012, he said.
Under EU legislation, all testing of cosmetics products on animals will be prohibited as of 2013, meaning alternate methods are needed to test such compounds for allergenic potential. The Sens-it-iv project was launched in 2006 to develop such methods. In 2008, Proteome Sciences won $883,000 to participate in the project and explore the potential of proteomics-based tests.
The Sens-it-iv project, which ended this year, held its scientific conference last week, where Proteome Sciences presented data on the eight assays. The company is now continuing the research independently, Pike said, but in coordination with industry bodies including the European Center for the Validation of Alternative Methods and the European Cosmetics Association.
“We’re talking with the various European stakeholders to understand what they are going to require of the validation phase and looking at the list of chemicals and making sure that we get access to them and run our methods on them with the appropriate levels of repeats with different operators in different labs,” Pike said.
“It took us a period of about four weeks to develop the [eight] proof-of-concept assays,” he said. “So we know that part of it is quick. What we now need to do is push through a whole bunch of known and unknown compounds, and that’s going to take several months.”
The assays will likely first be offered commercially out of Proteome Sciences’ ISO 9001-certified laboratory in Frankfurt, Germany, Pike said. He added that the company would also potentially license the assays “to larger multinationals who have a lot of this testing to do” so that they could perform the tests in house, as well as eventually package them as kits that can be sold for individual testing.
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