A Medical Device Daily

Genzyme (Cambridge, Massachusetts) said it has entered a license agreement with Massachusetts General Hospital (MGH; Boston) and the Dana-Farber Cancer Institute (DFCI; also Boston) to obtain exclusive, worldwide diagnostic rights to their discovery of gene mutations recently found in some patients with non-small-cell lung cancer.

The presence of these mutations, or markers, discovered in the epidermal growth factor receptor (EGFR) gene, has been shown to correlate with clinical response to certain drugs used in treating non-small cell lung cancer. Through this license, Genzyme will develop and market a diagnostic test for the EGFR markers that can be used to help identify patients who are most likely to respond to targeted lung cancer therapies, including Tarceva (erlotinib) and Iressa (gefitinib).

Responses to these drugs have been found to be positive in those patients identified as having specific EGFR gene mutations, Genzyme said. Its new test is designed to identify patients with those specific EGFR gene mutations, predict the responses to those drugs found to clinically correlate with such mutations and, ultimately, help extend the lives of patients undergoing therapy.

Genzyme said it expects to launch its EGFR mutation test later this year.

The discovery of the EGFR mutations was made by researchers at Dana-Farber and MGH who analyzed tumor samples from lung cancer patients who had responded to tyrosine kinase inhibitors of EGFR. According to their published studies, the majority of patients who had the mutations responded to the therapy, while those who did not have the EGFR mutations did not respond.

“We are eager for this technology to be widely available to physicians and their lung cancer patients, as it can help identify those who are likely to dramatically respond and survive for extended periods of time with a relatively benign treatment,” said Bruce Johnson, MD, director of the Lowe Center for Thoracic Oncology at Dana-Farber, who was involved in the discovery of the EGFR mutation.

In other grants/contracts news:

Berlex (Montville, New Jersey), a U.S. affiliate of Schering AG (Berlin) said the company has been awarded a new contract by Premier (San Diego), a group purchasing organization, to provide contrast media for MRI to members of the Premier network.

The new contract extends the nearly decade-long relationship between the two companies. Under the terms of the agreement, Berlex will provide Premier members access to Magnevist (gadopentetate dimeglumine) Injection, a contrast media for enhanced MRI.

The value of the contract is estimated to be in excess of $40 million annually.

Affiliated Computer Services (ACS; Dallas), a provider of business process and information technology outsourcing solutions, said that it has been awarded a contract by the Ohio Bureau of Workers’ Compensation (BWC) to provide pharmacy benefits management (PBM) services. The two-year contract is valued at $4.75 million and includes a pair of two-year options.

ACS will provide BWC with pharmaceutical claims processing, drug utilization review, real-time utilization management, and prior authorization services using the company’s proprietary SmartPA solution. ACS also will provide helpdesk and clinical call center services, and the design and maintenance of a maximum allowable costs list.

ACS first began providing PBM services to the BWC in 2002.