Imaging systems are lumbering into personalized medicine.
In a deal announced this summer between Roche and General Electric Healthcare, the companies will combine a novel GE imaging ligand with positron-emission tomography to track patient response to a Roche anti-amyloid Alzheimer’s disease drug during trials. “Using GE’s technology, we think we’ll be able to see a direct effect on the magnitude of benefit on the amyloid plaque,” says Dennis Burns, vice president, global head of business development at Roche. “We haven’t been able to do that before.”
The collaboration, in which PET will monitor a clinical drug trial, is the first of its kind since Janet Woodcock, acting deputy commissioner for operations at the US Food and Drug Administration, entreated diagnostic and imaging companies to employ molecular imaging technologies during clinical trials at the Molecular Medicine Tri-Conference in April.
Both companies hope that the trial will result in data that will allow them to gain FDA approval of their products — an imaging molecule in the case of GE, and an anti-amyloid in the case of Roche. “It really does show a significant forward movement toward personalized medicine that everyone’s talked about; there’s been great speculation, and now you’re beginning to see some very concrete things happening,” says Burns.
The companies intend to separately analyze patient data in order to independently evaluate each of their own products, and to submit data to the FDA individually. GE will submit all data related to the imaging agent, called Pittsburgh Compound B, or PIB, to the FDA for approval as a drug with diagnostic applications. “At this point, we aren’t far enough along to say whether this would be pivotal data,” says Don Black, global head of R&D for medical diagnostics at GE Healthcare Biosciences.
— Chris Womack
LabCorp will be working with Roche Diagnostics to validate its AmpliChip CYP450 and to evaluate the research leukemia microarray the diagnostic company currently has in development.
Abbott and Celera Diagnostics received CE Mark certification for the Abbot RealTime HCV assay, a real-time PCR test used to monitor hepatitis C viral load in patients. The certification means the companies can now market the test in the European Union.
The Methodist Hospital Research Institute teamed up with Power3 Medical Products to find protein biomarkers and develop various tests to diagnose neurodegenerative disease. In collaboration with Stan Appel at the Methodist Neurological Institute, Power3 has completed clinical validation by testing serum proteins from more than 600 patients with Lou Gehrig’s, Alzheimer’s, and Parkinson’s disease.
The state of Texas has committed $50 million to establish the Texas Institute for Genomic Medicine, which will offer a mouse stem cell library to researchers. Lexicon Genetics will receive $35 million of the award to create a library of 350,000 knockout mouse embryonic stem cell lines. The remaining $15 million will go to the Texas A&M University System for creating facilities and infrastructure to house the library.
US Patent 6,924,104. Methods for identifying genes associated with diseases or specific phenotypes. Inventors: Sherman Weissman; Xinghua Pan. Assignee: Yale University. Issued: August 2, 2005.
This patent covers “an improved method for screening genomic, cDNA, or any DNA fragments in general. … Novel adapters are ligated to the ends of DNA fragments from two different individuals or two different pools of individuals,” according to the abstract, and results come in the form of homohybrids or heterohybrids.
US Patent 6,919,176. Polypeptides and nucleic acids associated with cancer. Inventors: Jianxin Yang; Songzhu An. Assignee: Amgen. Issued: July 19, 2005.
This patent covers “methods, reagents, and kits for diagnosing and treating cancer in a mammal” and is “based upon the discovery that G2A, GPR4, GPR65, and OGR1 are overexpressed and/or amplified in cancer. Methods to detect cancer or a propensity to develop cancer, to monitor the efficacy of a cancer treatment, and to treat cancer, by inhibiting the expression and/or activity of G2A, GPR4, GPR65, and OGR1 in a cancer cell are included.”
The number of common diseases being studied as part of a collaboration between Perlegen Sciences Japan and RIKEN. The groups will perform association studies, including analysis of more than 250,000 SNPs, to find the causes of these diseases.