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Qiagen Inks Separate NGS Deals With Bristol-Myers Squibb, Johns Hopkins

NEW YORK (GenomeWeb) – Qiagen this past weekend said that it signed separate agreements with Bristol-Myers Squibb and Johns Hopkins University related to next-generation sequencing assay development.

Under one agreement, Qiagen and BMS will initially explore the use of NGS to develop gene expression profiles as predictive or prognostic tools for use with several BMS immuno-oncology therapies. The companies also plan to enter into a further agreement to develop diagnostic products using the jointly developed profiles to expand the use of NGS technology with other BMS immuno-oncology therapies.

"Greater precision in the treatment of cancer may enable faster decision making to identify which patient populations are most likely to derive benefit from our immuno-oncology agents," Fouad Namouni, head of development for oncology at BMS, said in a statement. "We believe working with Qiagen will help develop better diagnostic tools to target the most appropriate immunotherapies across a number of different tumor types."

Qiagen and BMS have been partnering since 2009, and achieved a key milestone in 2012 with the US Food and Drug Administration approval of the Therascreen KRAS companion/complementary diagnostic assay.

In a note to investors, William Quirk of Piper Jaffray noted that any companion diagnostic that Qiagen develops under the agreement with BMS will likely be exclusive to Qiagen's GeneReader, which could go a long way toward driving uptake of the platform.

"We have never been big fans of GeneReader with the sequencer locked down (i.e., can only use Qiagen's panels) and there is no GeneReader-exclusive content. … [W]e believe the company is now on its way to offering exclusive tests for the instrument," Quirk wrote. "We view bolstering exclusive content on GeneReader as improving the system's competitive edge and should help with future placements, in our opinion."

In the second deal announced this weekend, Qiagen said that it recently received a worldwide license from Johns Hopkins University for biomarkers that have been shown to play key roles in identifying patients who could benefit from novel immuno-oncology therapies.

The agreement involves rights to genetic biomarkers to assess microsatellite instability (MSI) and mismatch repair (MMR) in all sample and cell types, and gives Qiagen the option to commercialize NGS assays to assess MSI and MMR status.

Levels of MSI and MMR, along with tumor mutation burden, are important in identifying cancer patients who could benefit from certain types of immuno-oncology therapies. Qiagen said that it reached this agreement prior to the FDA approval last month of an immuno-oncology therapy to treat advanced solid tumors with MSI and MMR deficiencies — Merck's PD-1/PD-L1 inhibitor Keytruda (pembrolizumab) — marking the first time that the FDA has cleared a cancer drug for use not tied to the site of a tumor.

It is unclear whether Qiagen will develop such assays for multiple sequencing platforms or only for the GeneReader.

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