Qiagen and Abbott are joining forces to fortify their testing menus for automated in vitro diagnostics in the U.S. and Canada. Qiagen will receive kits for a PCR-based molecular assay for HIV-1 viral load testing in the U.S. and Canada. The firm expects to make the test available by 2012, and they will be commercialized under the Qiagen brand.
Additionally, Abbott will provide a quantitative HCV test that will be optimized and labeled for use on Qiagen’s QIAsymphony RGQ instrument and marketed under the Abbott brand in the U.S. and Canada. Subject to regulatory approval, this test may be available by the end of 2012.
Qiagen will also supply Abbott with certain key products required for a PCR-based HPV test in the U.S. and Canada. It will run on Abbott's m2000 lab automation system, which features throughput of up to 96 samples per run.
Qiagen will continue development of HPV molecular diagnostics based on its QIAensemble platform, which is designed to process up to 2,000 samples per shift. These HPV screening assays are not subject to the transaction.
Qiagen's QIAsymphony RGQ system was launched last month with assays including HIV, HBV, and HCV. It is registered for clinical use in European markets. Commenting on the transaction, Qiagen’s CEO, Peer Schatz, says, “It has the potential to significantly accelerate our dissemination strategy for the QIAsymphony RGQ by expanding our molecular diagnostic menu offering in the United States with important testing options.
“It also allows us to commercialize previously unused intellectual property around a PCR design for HPV assays by converting it into revenue and by targeting it into a clearly defined sub-segment of the market,” Schatz continues. “And, finally, it enables both parties to address the different market segments for HPV and thereby promises to further drive market adoption of this important testing method in North America.”
Tests for HIV and HCV are currently among the most widely used commercial applications in molecular diagnostics, with U.S. markets estimated to be in the range of $180/$140 million in annual sales, respectively, according to the companies.
Qiagen’s portfolio currently includes FDA-approved assays for HPV (digene HPV) and chlamydia as well as CE-labeled tests for the detection of HIV, HCV, HBV, cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes-simplex virus (HSV), influenza, multiple bacteria and respiratory viruses, and personalized healthcare assays like KRAS and EGFR.
Abbott offers a broad menu of tests on its m2000 system outside the U.S., including tests for HIV viral load, hepatitis B and C viral load, hepatitis C genotyping, chlamydia, gonorrhea, HPV, CMV, EBV, and methylated septin 9 (mS9) for colorectal cancer. Tests approved in the U.S. include those for HIV, HBV, chlamydia, and gonorrhea.