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, told BioArray News this week 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 last week 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 explained. Pamgene uses its own software for research purposes, he said.
Goossens said 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, told BioArray News that the HLA typing assay had a preliminary launch date of late 2006 (see BAN 3/28/2006).
In June, the company affirmed its intentions to launch in the third quarter. Now Goossens said that the firm is committed to getting the HLA typing test out on the market this year.
“This year our focus is HLA,” he said.
Goossens said that Innogenetics is prepared to target both the US and EU markets, and added 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.
“For our first series of tests, RUO may suffice in [the] US, but at the same time we will start with the necessary processes towards FDA approval,” Goossens said.
Sales of the 4-MAT instruments and related products in the US will be handled out of Innogenetics subsidiary in Atlanta. “The kits, 4-MAT machines, and services will be handled from these premises,” Goossens said.
“For our first series of tests, [research-use-only] may suffice in [the] US, but at the same time we will start with the necessary processes towards FDA approval.”
Innogenetics develops the machine for microarray reading and develops the tests in a kit format, Goossens said. “We do not provide for in-house testing of samples.”
“The machine will be bought or leased by tissue typing laboratories first, and later by other laboratories for tests in their field,” he said. “The kits will be shipped from our premises to those customers for use on 4-MAT.”
In March 2006, PamGene’s Jordan said that Innogenetics plans to introduce additional tests on the 4-MAT instrument, including tests for cystic fibrosis and the mannose-binding lectin 2 (MBL2) gene, expected this year, and for infectious disease, neurodegeneration, oncology, and immunuological diseases, due in 2008.
This week Goossens declined to comment on any of these tests, stating that for the genetic tests the “development programs are also in progress,” and “first beta-trials are expected end this year” (see BAN 3/28/2006).