A Diagnostics & Imaging Week

The Critical Path Institute (C-Path; Tucson, Arizona) and Ventana Medical Systems (also of Tucson) released additional information about C-Path’s $2.1 million grant from Science Foundation Arizona (SFAz) to fund a collaboration project with the (FDA) and the National Cancer Institute (NCI; Bethesda, Maryland) to develop a standard testing and evaluation process for companion diagnostics and their associated targeted cancer therapies.

Currently, there is no proven development pathway for FDA approval of the necessary companion diagnostic tests and their associated targeted therapies. The goal of this collaboration is to establish the performance standards that would serve as the model for future FDA co-submissions of these companion diagnostic tests and their targeted drug therapies. With the SFAz grant, C-Path and Ventana will work closely with the FDA and NCI to apply these standards to one of Ventana’s in-process companion diagnostic tests for lung cancer.

Gary Kelloff, Senior Scientist at the National Cancer Institute said, “We applaud the collaboration among the Science Foundation Arizona, The Critical Path Institute and Ventana Medical Systems on the important project of creating a standardized evaluation process for diagnostic tests. The results of this work will complement the anticipated collaborative project with the NCI.”

C-Path’s Chief Scientific Officer and Principal Investigator on this initiative, Jeffrey Cossman, MD, said, “The award from Science Foundation Arizona will fund an important step toward making the next generation of important patient care solutions a reality. The ultimate goal of the project is to guide the choice of targeted therapy so that patients receive the most effective treatments.” President/CEO Raymond Woosley, MD, PhD, added, “This is extremely important work, and we are fortunate to have Ventana, a global leader in cancer diagnostics, as our partner.”

Christopher Gleeson, president/CEO of Ventana, commented, “Ventana’s collaboration with C-Path furthers our commitment to personalized medicine and our view that companion diagnostics will increasingly become a key factor in the development and administration of many new cancer therapies.”

C-Path’s mission is to help implement the FDA’s Critical Path Initiative by developing faster, safer and smarter pathways to new medical products.

Ventana develops instrument/reagent systems that automate tissue preparation and slide staining in clinical histology and drug discovery laboratories worldwide.

In other agreements:

• Covidien Imaging Solutions (St. Louis) and BioSynthema (also St. Louis) reported the signing of agreements to make a nuclear medicine therapy for neuroendocrine cancer patients. Under the terms of an exclusive license agreement, BioSynthema will gain access to specific Covidien peptide technology. The license will enable BioSynthema to use this technology in conjunction with its own technology and proprietary clinical research to further develop a new targeted radionuclide therapy product. Under the terms of a separate agreement, Covidien will have exclusive marketing rights to the resulting cancer therapy technology.

The new technology utilizes a radiolabeled peptide that targets specific somatostatin receptors on neuroendocrine cancer cells. If approved, this drug candidate will add to Covidien’s portfolio of nuclear medicine oncology agents, including OctreoScan (kit for the preparation of indium In-111 pentetreotide), a molecular imaging agent which is indicated for the scintigraphic detection and localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.

Under the terms of the agreements, BioSynthema will develop and manufacture the product and Covidien will be responsible for worldwide marketing, sales and distribution. The companies plan to pursue marketing authorization in Europe and the U.S. initially.

• Illumina (San Diego) said that it has agreed to process more than 6,500 samples for researchers of the Type 1 diabetes genetics consortium (T1DGC) via its FastTrack genotyping services. With financial support from the NIDDK, the T1DGC will attempt to identify genes that influence an individual’s risk for developing Type 1 diabetes.

To date, Illumina’s FastTrack genotyping services group has processed more than 300,000 samples and generated more than 18 billion genotypes, helping researchers around the world to identify genes linked to a number of complex diseases, including psychological disorders, asthma, and cancer.

Illumina makes life-science tools and integrated systems for the large-scale analysis of genetic variation and biological function.

• TomoTherapy (Madison, Wisconsin) said it has partnered with Integra Radionics (Burlington, Massachusetts), a subsidiary of Integra LifeSciences (Plainsboro, New Jersey), to develop and distribute the InterFix radiosurgery kit. The kit includes a suite of fixation products that have been adapted for use in stereotactic procedures using the TomoTherapy Hi Art treatment system.

According to Del Coufal, VP of marketing for TomoTherapy, the InterFix kit complements the Hi Art treatment system well.

“Radionics products are used in cancer centers around the world. With the InterFix kit, their head rings and fixation tools will work seamlessly with our system, adding to the clinical confidence our integrated CT guidance and helical delivery already make possible,” Coufal said.