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Foundation Medicine Enters into Companion Diagnostic Collaboration

6 Aug 2012
Sonia Nicholas
Managing Editor and Clinical Lead

Industry news

Foundation Medicine, Inc. and Clovis Oncology, Inc. have entered into a diagnostic collaboration. The goal of the collaboration is to develop an in-vitro diagnostic (IVD) to identify biomarkers to select cancer patients most likely to respond to Clovis’ product candidate rucaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor currently in Phase I/II clinical development.

“We are pleased to collaborate with Foundation Medicine,” said Patrick J. Mahaffy, president and CEO of Clovis Oncology. “This continues our commitment to developing targeted therapies with companion diagnostics to identify the patients most likely to benefit from our therapeutics. Foundation Medicine’s leadership in next generation sequencing and genomic analysis make them an ideal partner to work with us on our rucaparib program.”

Foundation Medicine and Clovis Oncology will analyze the genomic alterations found in tissue samples from patients to evaluate the feasibility of developing an IVD method to identify patients who have tumors more likely to respond to rucaparib.

In particular, the goal of the collaboration is to identify the additional genetic mutations beyond those in germ-line and somatic BRCA that are associated with defective DNA repair and may define appropriate tumor targets for rucaparib. In high-grade serous ovarian cancer, for example, this study has the potential to increase the percentage of ovarian cancer patients potentially eligible for rucaparib therapy from the 15 percent typically found to have germ-line mutations of BRCA to an estimated 40 to 50 percent who have DNA repair deficiencies caused by somatic mutations in a variety of genes.

“Foundation Medicine’s core capability is the translation of genomic insights into clinically actionable information,” said Michael J. Pellini, M.D., president and CEO of Foundation Medicine. “But even the most in-depth genomic profile for a patient is only as actionable as the available and relevant targeted therapies. Therefore, we are working to help expand the universe of targeted therapeutic options. Clovis Oncology, a recognized leader in patient-specific oncology drug development, is an ideal partner in this mission.”

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Genome AnalysisGenomics, the study of genomes, includes functional genomics, evolutionary genomics and comparative genomics. There are many genomic technologies such as DNA sequencing of whole genomes, computational biology and bioinformatics. DNA and nucleic acids must be isolated and concentrated from cells for analysis with kits, automated analyzers and software. Other useful technologies for studying genomics include PCR, microarrays and electrophoresis.Medicinal ChemistryMedicinal chemistry is a broad discipline encompassing the design, identification, synthesis and development of chemicals in drug discovery. It includes a number of techniques covering structural biology, synthetic chemistry and molecular biology. Technologies used in medicinal chemistry include ADME, lab-on-a-chip, high content screening and assay assembly.Gene Expression and Molecular CloningMolecular cloning is a set of techniques that utilizes vectors to transfer recombinant DNA into host cells and is an essential tool for investigating the expression of genes and proteins in bacterial or mammalian cells. A variety of vectors optimized for gene cloning and expression in a range of host organisms are available, alongside competent cells for genetic replication. Here, you can explore a range of molecular tools, high-quality genomic and cDNA libraries, premade clones, transformation and transfection reagents and mutagenesis or gene expression detection assays and expression arrays. Find the best gene expression and molecular cloning products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.BiomarkersBiomarkers are biological markers which can be measured and evaluated to indicate a biological state. The use of biomarkers in research and diagnosis can indicate a normal or disease state or drug response of cells / tissues. Biomarkers include genetic markers, cell surface markers such as antigens, antibodies or receptors and secreted molecules such as cytokines. An assay system is required for identification of biomarkers. :Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Companion DiagnosticsCompanion diagnostics are tests, often <i>in vitro</i>, that are used to determine whether a therapeutic product will be safe and effective for use on an individual. They also identify which patients will benefit most from them. Companion diagnostic tests are often developed in conjunction with the pharmaceutical industry.

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Foundation Medicine Enters into Companion Diagnostic Collaboration