Roche’s Von Prondzynski Says All is as Planned With FDA and AmpliChip
Last week, when Roche presented it first-half 2003 financial update, Heino von Prondzynski, head of the pharmaceutical giant’s diagnostic division, addressed financial analysts and said that the company will work with the agency to define a standard for analyte specific reagents based on microarray technology.
“The FDA has invited us to talk with them about this new product because, so far, there are no existing standards for such a highly innovative product,” he said. “This is what we expected. We spoke to the FDA before we launched the product as an ASR. But, as this really is a highly innovative technology, we need,
together with the agency, to define the standard. What we are doing now with the FDA is defining the standard and then, according to this, also filing for an FDA approval, which we always wanted to do for the AmpliChip side of CYP450. We can, and this is what we planned, to sell it to selective reference labs. So we provide them with a product and they do the clinical trials together with us, thus supporting the filing documents with the FDA.”
Roche released its AmpliChip CYP450 product in June, and within days, was slapped with a letter from the FDA asking the company to meet with it to discuss the marketing of this product as an analyte specific reagent, raising questions of the propriety of microarray-based genetic tests marketed without regulatory review.
New Microarray Core Opens at Wake Forest University
Earlier this month, Wake Forest University Baptist Medical Center in Winston-Salem, NC, unveiled a new microarray core facility built around the Affymetrix GeneChip platform. The facility is directed by Yong Chen, associate professor of cancer biology and endowed professor of the Prostate Cancer Center of Excellence. Funds for the facility were provided half by Wake Forest University School of Medicine, and half by private donations to the school’s Comprehensive Cancer Center.
Spain to Launch Biochip to Detect Familial Hypercholesterol Genes
Laboratorio Laser, Spain’s national pharmaceutical firm, later this year will introduce a biochip developed to detect some 150 mutations discovered by researchers under the leadership of Miguel Pocovi, director of the departments of biochemistry and cell and molecular biology at the University of Zaragosa. Specifically, the biochips will be used to identify genes that cause familial hypercholesterol. The test is expected to cost $350 and take 48 hours to complete, according a report in the July 28 edition of Newsweek.
TransForm To Develop In Vitro Cell Differentiation Technology
TransForm Pharmaceuticals of Lexington, Mass., last week announced that it has received a contract from the US Defense Advanced Research Projects Agency (DARPA) to develop a prototype system for the discovery of methods and compositions to control in vitro cell differentiation. Financial details were not disclosed.
The system, being developed as part of the DARPA’s Engineered Tissue Constructs Program, will enable microarray-based screening of complex mixtures that control and promote cell growth.
The company, founded in 1999 with its initial technology from Millennium Pharmaceuticals, is commercializing high-throughput analysis platforms to identify chemical and physical forms and formulations of drug molecules.
Point Licenses Incyte’s Microarray Patents
Point Technologies of Boulder, Colo., has non-exclusively licensed two microarray-related patents from Incyte, the company recently reported, and will use them to make and sell split microarray spotting pins.
The US patents are:
• No. 5,807,522, “Methods for Fabricating Microarrays of Biological Samples,” issued September 15, 1998,
• No. 6,110,426, “Methods for Fabricating Microarrays of Biological Samples,” which are directed to a method of making a nucleic acid array by tapping the tip of a dispensing device against a solid support.
The Incyte agreement grants a worldwide, nonexclusive, nontransferable, nonsublicensable license to the patents, to make and sell split microarray spotting (printing) pins.
The license agreement will allow direct end users, such as core facilities, to buy and use Point Tech Accelerator split spotting pins for internal research purposes.
It will also allow robotic microarrayer manufacturers to offer the Accelerator split pins for sale to their customers for the same end.