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Qiagen-Abbott HPV, HIV, HCV Pact Expands PCR-Based Test Menu for Both Companies

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This article has been updated from a previous version to include comments from Qiagen and Abbott spokespersons.

By Ben Butkus

Qiagen and Abbott said yesterday that they have inked a broad licensing and commercialization deal intended to significantly strengthen the in vitro diagnostic test menus available in North America on each company's automated, real-time PCR-based instrument platform.

In addition, the companies said that they have separately resolved a lawsuit filed by Abbott against Qiagen earlier this year related to intellectual property surrounding PCR-based methods for detecting human papillomavirus.

Under the terms of the licensing agreement, the financial details of which have not been disclosed, Qiagen has given Abbott access to "certain key products" required for a PCR-based HPV assay, which Abbott will develop for its m2000 laboratory automation system and market in the US and Canada.

In exchange, Qiagen will receive from Abbott kits for a PCR-based assay for HIV-1 viral load testing, which will be commercialized in the US and Canada under Qiagen's brand. In addition, Abbott will provide Qiagen with a quantitative hepatitis C test, which will be optimized and labeled for use on Qiagen's QiaSymphony RGQ instrument and marketed under the Abbott brand in the US and Canada, the companies said.

In a statement, Qiagen CEO Peer Schatz said that the agreement enables both parties to address different market segments for HPV testing and thus further drive market adoption of such testing in North America.

Meantime, Stafford O'Kelly, head of Abbott's molecular diagnostics business, said in a statement that "the addition of a PCR-based HPV test to our m2000 menu will benefit many more women who may be infected with the virus and at risk of developing cervical cancer."

In general, despite the licensing pact, both companies will continue to compete in the molecular diagnostics marketplace even as they provide each other with access to IP or molecular tests that will enable each to offer broader test menus on their instrument platforms, company officials said.

"We are both molecular diagnostic companies, and both active in infectious disease testing, and we found a solution with this agreement that both companies will be better off with," Qiagen spokesperson Thomas Theuringer told PCR Insider.

"Both companies are still competing against each other," Abbott spokesperson Don Braakman wrote in an email to PCR Insider. "With regard to these agreements, as both companies’ offerings complement each other, we believe these agreements will provide increased access to important molecular diagnostic tests that will benefit an even greater number of patients."

At the crux of the agreement are molecular testing methods for HPV, which were the subject of a lawsuit filed in February by Abbott against Qiagen (PCR Insider, 2/11/10).

In the suit, Abbott sought to compel Qiagen to arbitrate a dispute linked to a licensing deal signed in 1995 between Abbott and Viropath, which granted Abbott and its affiliates the freedom to make and sell products under US Patent No. 5,364,758, "Primers and process for detecting human papillomavirus genotypes by PCR."

Eventually, Viropath assigned the patent to Digene; and in 2007 Qiagen acquired Digene, thus assuming control of the IP. Qiagen subsequently accused Abbott of not paying royalties owed and said it was in breach of contract, even thought Abbott had not yet begun selling products related to the PCR-based HPV testing methods.

Abbott denied the accusations and, after a series of additional disputes surrounding the IP, invoked an arbitration clause that was included in its original agreement with Viropath designed to allow the feuding companies to hammer out an agreement.

In the meantime, Qiagen developed and commercialized its own molecular test based on IP acquired from Digene, the HC2 HPV DNA test, which is based on a signal-amplification technology called hybrid capture 2.

Qiagen claims this test, which has regulatory approval in CE-Marked countries and the US, is superior to PCR-based methods. Thus it would seem that the company no longer had a need for the patents surrounding PCR-based HPV testing methods.

According to court documents filed in April, the US District Court for the Northern District of Illinois where the case was filed ruled in favor of Abbott's request for arbitration in the matter. This week, both Theuringer and Braakman told PCR Insider that the companies settled their dispute separately from the licensing and commercialization agreement, although they did not provide details of the settlement.

Nevertheless, Qiagen's Schatz said in a statement this week that the new agreement will allow Qiagen to commercialize "previously unused IP 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."

That "clearly defined sub-segment," according to Abbott's Braakman, is a lower-throughput testing market in the US and Canada.

"The agreement will allow Abbott to market an HPV test on the m2000 system in the US and Canada, but serving a different market segment than Qiagen's HPV test," Braakman said. "Qiagen will be targeting the high-throughput screening segment, while Abbott’s m2000 platform addresses laboratories with lower throughput requirements." He added that both Abbott and Qiagen currently offer HPV tests in Europe for different segments of the market.

Meantime, on the HIV testing front, both companies already have molecular tests for monitoring viral load of HIV-1 patients. Specifically, Abbott sells the RealTime HIV-1 viral load test in the US, Canada, and other markets for use on the m2000; while Qiagen offers a CE-Marked HIV test optimized for the QiaSymphony.

Under the new agreement, Abbott will develop an HIV-1 viral load monitoring test for use on the QiaSymphony RGQ, and Qiagen will seek regulatory approval in the US for the kits and, assuming they are approved, will eventually sell and market the kits under its name in North America.

"We already have an HIV test optimized for the QiaSymphony platform, which is CE marked and available here in Europe," Qiagen's Theuringer said. "We don't have an FDA-approved test. That's the rationale behind the agreement with Abbott. What both we and Abbott want to do is drive the sales of the platforms with a broader test portfolio or test panel. Of course you can have a fantastic platform, but what's driving the sales is the content."

Finally, Qiagen and Abbott struck a similar deal regarding hepatitis C testing: Abbott will provide a quantitative test that will be optimized and labeled for use on the QiaSymphony RGQ. However, Abbott will seek regulatory approval for and market this test in the US and Canada, as Qiagen already has a hepatitis C test available for use on the QiaSymphony, according to Theuringer.

Abbott also markets a hepatitis C viral load test called the Abbott RealTime HCV in Europe and other countries, and its test is currently pending regulatory approval in the US, according to Braakman. Thus, this part of the agreement will eventually allow Abbott to sell hepatitis C molecular tests on either an Abbott or Qiagen platform.

Pending regulatory approval, both the Abbott-developed, Qiagen-marketed HIV test; and the Abbott-developed hepatitis C test for Qiagen's platform are expected to be available in 2012, the companies said.

Qiagen's current molecular testing portfolio includes FDA-approved tests for HPV and chlamydia; and CE-Marked tests for detecting HIV, HCV, hepatitis B, cytomegalovirus, Epstein-Barr virus, herpes-simplex virus, influenza, and multiple bacteria and respiratory viruses.

In addition, the company has a broad pipeline of assays planned for launch on its QiaSymphony and QiaEnsemble platforms in the US, Europe, and other countries over the next two years.

Abbott's test menu for the m2000 system outside the US includes tests for HIV viral load, hepatitis B and C viral load, hepatitis C genotyping, chlamydia, gonorrhea, HPV, CMV, Epstein-Barr, and methylated septin 9 for colorectal cancer. Its US-approved tests include those for HIV, hepatitis B, chlamydia, and gonorrhea.

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