A Medical Device Daily
Qiagen (Venlo, the Netherlands) has entered into a partnership with Pfizer (Germantown, Maryland) for the development of a companion molecular diagnostic test for use with an investigational Pfizer compound in global clinical development for treatment of non-small cell lung cancer (NSCLC). Financial terms of the agreement were not disclosed.
Pfizer's investigational compound, dacomitinib, is an oral inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases. The HER (human epidermal growth factor receptor) signaling pathway plays a role in the complex process of cell growth and metastasis, making it a target for anti-cancer drugs.
Qiagen's proposed companion diagnostic will be based on its KRAS assay technology, which detects mutations of the KRAS gene that are frequently found in human cancers. Because EGFR inhibitors are generally effective in patients without these KRAS mutations, the Qiagen assay can be useful in identifying patients most appropriate for EGFR-inhibitor therapies. Qiagen recently submitted the application for Premarket Approval (PMA) for KRAS companion diagnostics to the FDA for use with two other, separate drugs targeting metastatic colorectal cancers. The Pfizer drug companion diagnostic test is being specifically developed for use in lung cancer tissue. It uses the same core assay component as the therascreen KRAS RGQ kit for colorectal cancers but varies in the workflow to allow for lung tissue-specific sample technology in a fully automated workflow.
Qiagen and Pfizer will engage in collaborative efforts to develop the KRAS companion diagnostic for use with dacomitinib. The partnership covers clinical trials and submissions for a PMA application in the U.S. and the CE mark in Europe, as well as applicable regulatory approvals in other regions.
“We are pleased to collaborate with Pfizer seeking to advance personalized healthcare with a new potential tool in the fight against non-small cell lung cancer, a major killer around the world,“ said Stephen Little, VP personalized healthcare at Qiagen. “This partnership unites Qiagen's capabilities in companion diagnostics with Pfizer's scientific excellence and global presence to develop an innovative diagnostic-therapeutic combination with the potential to improve the standard of care for NSCLC patients.“
Qiagen is a provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue.
In other agreements/contracts news,
• Quanterix (Cambridge, Massachusetts), a company specializing in molecular diagnostic tests based on its Single Molecule Array (SiMoA) technology, and Stratec Biomedical (Birkenfeld, Germany), a maker of automated analyzer systems, reported an agreement to co-develop an automated instrument for Quanterix's SiMoA technology for use in both the life sciences and in vitro diagnostics (IVD) markets. Quanterix expects to launch a life sciences instrument in 2013, followed by the commercialization of an IVD platform in 2014.
As part of the agreement, Quanterix will receive access to Stratec's platform technology, which will be customized to both optimize and automate the advanced applications of Quanterix's SiMoA technology. Stratec will receive payments, as well as a minority stake of approximately 7% in the share capital of Quanterix, upon the achievement of technological milestones. After completion of the development phase, Stratec will manufacture and supply the system and Quanterix has committed to order an agreed minimum volume of systems.
“We are very pleased to work with Quanterix on the development of an instrument that facilitates automation of this potentially game-changing technology,“ said Marcus Wolfinger, chairman/CEO of Stratec Biomedical. “The quality and potential for Quanterix and its technology is evidenced by the background and accomplishments of the Quanterix team, and we look forward to providing a platform solution that will allow Quanterix to expand the utility of SiMoA in both the life sciences research and IVD markets.“
• Drug delivery company pSivida (Watertown, Massachusetts) has entered into an evaluation agreement with Hospital for Special Surgery (HSS; New York), a specialist in orthopedics, rheumatology and rehabilitation, to investigate pSivida's drug delivery technologies in orthopedics.
“We believe this orthopedic evaluation agreement is important for pSivida as our drug delivery technology, originally developed for ophthalmology, is being investigated in broader areas of medicine,“ said Paul Ashton, president/CEO of pSivida. “We are excited to be working with Hospital for Special Surgery because of their long history of innovation and research in orthopaedic surgery.“
HSS has received Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center, and has one of the lowest infection rates in the country. pSivida makes drug delivery products that are administered by implantation, injection or insertion and provide sustained release of drugs on a controlled and level basis for months or years.
• American Shared Hospital Services (AMS; San Francisco), a provider of turnkey technology solutions for advanced radiosurgical and radiation therapy services, has entered into a contract to supply a Gamma Knife Perfexion system to St. Vincent's Medical Center (Jacksonville, Florida). The Perfexion system will be an upgrade to an existing Gamma Knife supplied by AMS to another hospital in the area that comes off lease at the end of this month. Pending regulatory approval, patient treatments on this Perfexion system are expected to begin in the fourth quarter.
St. Vincent's Medical Center is a 528-bed comprehensive, acute care hospital.
According to its manufacturer, Elekta (Stockholm, Sweden), Gamma Knife Perfexion reduces unwanted body dose to the patient by up to 100 times compared with competing technologies, which is particularly important for treatment of children and women of childbearing age, and allows for a dramatically increased treatable volume, which is expected to increase the number of patients that can benefit from Gamma Knife surgery. Elekta estimates that the fully automated and efficient single push-button approach can save 3-5 working weeks of physician time per year at an average Gamma Knife center.
• The Premier (Charlotte, North Carolina) healthcare alliance reported a new agreement for workforce solutions has been awarded to RightSourcing (Irvine, California).
Premier maintains a repository of clinical, financial and outcomes information and operates a healthcare purchasing network.