Innogenetics, a Belgian diagnostics firm that offers a growing line of testing services based on a PamGene-manufactured microarray platform, is preparing to launch a test for human leukocyte antigen testing, according to a company official.
Filip Goossens, business development manager at Innogenetics, says that the company plans to introduce the HLA tissue-typing test in Europe and North America this summer.
The launch coincides with robust growth in the company’s diagnostic business. The company reported in March that 2006 revenues jumped nearly 11 percent to €53.7 million ($70.4 million), buoyed by existing diagnostics sales.
According to Goossens, Innogenetics’ new test uses its internally developed 4-MAT instrument, which is based on PamGene’s PamStation-12. “The PS12 system hardware is identical to the 4-MAT instrument, but the [in vitro diagnostic]-quality software for controlling the instrument and analyzing the test results is proprietary to Innogenetics,” Goossens says. Pamgene uses its own software for research purposes, he adds.
Goossens says that Innogenetics plans to launch the HLA tissue-typing test by summer and that the first assay will be for HLA-A, a subclass that the company believes will become a useful test doctors can prescribe for patients about to undergo kidney or bone marrow transplantation.
Innogenetics and PamGene have been partners since 2004, and last year Bertrand Jordan, a member of PamGene’s scientific advisory board, said that the HLA typing assay had a preliminary launch date of late 2006.
In June, the company affirmed its intentions to launch in the third quarter. Now Goossens says the firm is committed to getting the HLA typing test out on the market this year.
Goossens says that Innogenetics is prepared to target both the US and EU markets, adding that the tests could originally be marketed as research-use-only for sales to clinical labs, but that Innogenetics is eyeing clearance by the US Food and Drug Administration in the future.
— Justin Petrone
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