Originally Published IVD Technology January/February 2003
INDUSTRY NEWS
NotablesFDA has established an Office of Combination Products (OCP) under the Office of the Commissioner to streamline the processing of complex drug-device, drug-biologic, and device-biologic combination products. The OCP will be responsible for the regulation of these products, including the resolution of jurisdictional impasses, the timeliness and effectiveness of premarket review, and the consistency and appropriateness of postmarket regulation.
The principal regulatory responsibilities for and the oversight of specific types of combination products will remain in the hands of one of three product centers, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, or the Center for Devices and Radiological Health, to which they are assigned.
An in vitro test requiring only a few drops of blood may replace angiography in screening for atherosclerosis. Developed at Imperial College London and the University of Cambridge, the test uses metabonomics to send high-frequency radio waves into the sample to measure the magnetic properties of the molecules within. In small-scale trials, the test performed at a 95% accuracy compared with full-scale angiography, and predicted the severity of heart disease in 80% of the cases. The test is undergoing larger trials at Papworth Hospital (Cambridgeshire, UK). If these trials are successful, the test could be widely available within two years.
Metabonomics offers an advantage over other technologies because it can be used on standard preparations of serum, plasma, and urine without any specialist preparations. Elaine Holmes, PhD, from Imperial College London, states, "Metabonomic technology has the potential to help detect and diagnose a wide range of clinical problems, from bone disease to cancer. A visit to the doctor's a decade from now could be very different—a single blood or urine test might tell the doctor in minutes which diseases you are likely to suffer from, and even which drugs will be most effective."
Merck Sharp & Dohme (Essex, UK), has developed a vaccine against human papiloma virus (HPV), the virus linked to almost all cases of cervical cancer, which could eventually eliminate the need for Pap smear tests. Early clinical trials of the vaccine have shown it to be 100% effective. The vaccine fights four of the most common strains of HPV, including the one that causes genital warts.
Although further trials are necessary, the vaccine could be widely available within a few years. It would only work in females who had not yet become sexually active, because HPV is transmitted through sexual intercourse. The virus is carried by an estimated 15% of women between ages 20 and 30, and 6% of women over age 40. Most do not go on to develop cervical cancer.
The Nobel Prize in Chemistry was awarded for the development of two methods of chemical analysis used to determine the identity and structure of biological macromolecules. Half of the award was shared by John B. Fenn, PhD, professor of analytical chemistry at Virginia Commonwealth University (Richmond, VA) and Koichi Tanaka, a fellow of the Shimadzu Corp. (Kyoto, Japan) for developing soft desorption ionization methods for mass spectrometric (MS) analyses of proteins.
The other half of the award was presented to Kurt Wüthrich, PhD, professor of biophysics at the Swiss Federal Institute of Technology (Zürich, Switzerland) and visiting professor of structural biology at the Scripps Institute (La Jolla, CA) for his use of nuclear magnetic resonance (NMR) spectroscopy to determine the three-dimensional structure of proteins in solution, an environment similar to that inside living cells.
Both researchers' MS methods have been used to determine the presence, progression, and function of breast, ovarian, colon, and prostate cancer. NMR spectroscopy has also been used to detect and characterize cancer. Both continue to be integral investigational components of the field of proteomics.
FDA has cleared for marketing the Elecsys proBNP immunoassay, an automated lab test that will aid in diagnosing congestive heart failure. Roche Diagnostics Corp. (Indianapolis) manufactures the assay, which is the first fully automated test designed for this purpose. It is designed to run on Roche Diagnostics' Elecsys analyzers, and this automation allows the laboratory to run a higher volume of samples. The test detects the level of the peptide NT–proBNP, which is secreted almost exclusively by the heart. Elevated levels of this peptide can be indicative of congestive heart failure.
Cepheid (Sunnyvale, CA) and the Applied Biosystems Group (Foster City, CA) will collaborate to develop and sell reagents and cartridges for use with Cepheid's GeneXpert system, which will be designed to detect biothreat agents. Under the agreement, the product will be designed with direct applications for a biological detection system geared for potential deployment within United States Postal Service (USPS) mail-sorting facilities. The system is currently under development by a consortium, that includes Cepheid and is led by Northrop Grumman Corp.
"The combination of Applied Biosystems' reagent development capability and extensive experience in the field of real-time DNA testing will strongly complement Cepheid's expertise in developing real-time genetic testing systems," said Tom Gutshall, chief executive officer of Cepheid. "Cepheid's unique GeneXpert system and test cartridges enable the benefits of genetic testing to be taken to the point of need, such as in a USPS facility, advancing our nation's ability to rapidly and precisely identify the presence of biothreat agents." Systems will be installed and tested at 14 USPS facilities, in an effort to validate the performance of the final design.
Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), FDA will be required to report to Congress on Center for Biologics Evaluation and Research (CBER) review times for in vitro diagnostics. In this report, which should be submitted within a year of MDUFMA's enactment, FDA will recommend whether the responsibility of regulating combination products (products that incorporate at least two of the regulated component categories of device, drug, or biologic into one product) should be reassigned from CBER to the Center for Devices and Radiological Health (CDRH).
The report will address the time it takes for FDA centers other than CDRH to review original submissions, review manufacturers' replies to submissions, and to approve or clear devices. FDA will also suggest measures to improve performance, including whether Congress should set FDA funds aside for IVDs. The device industry believes that CBER has given priority to products for which it receives user fees, assigning devices and diagnostics a lower priority. CBER states that the disparity in review times is due to the greater complexity of devices that contain biologics components. To even out this disparity, MDUFMA requires device manufacturers to provide user fees for the premarket review of their products.
In May 2002, a draft agreement between industry and FDA specified review targets for original biologics licensing applications and BLA supplements as well as for PMAs and 501(k) reviews. The agreement also directs FDA to consider a process for 'bundling' simultaneous submissions sent by a single company. FDA will either issue a draft guidance on bundling or, if the agency decides that grouping submissions is not appropriate, it will explain its reasoning in the Federal Register.
FDA commissioner Mark McClellan appointed Jesse Goodman, MD, to replace Kathryn Zoon, PhD, as director of FDA's Center for Biologics Evaluation and Research (CBER). Zoon, who had served as director of CBER since 1992, resigned that post on December 13 to accept the position of principal deputy director for research in the Center for Cancer Research at the National Cancer Institute.
Goodman is a virologist who is board certified in internal medicine, oncology, and infectious diseases. In 1998, he joined FDA's Office of the Commissioner where he directed the Interagency Task Force on Antimicrobial Resistance. He later joined CBER, where he has worked in bioterrorism preparedness and response, product development, human subject protection, and blood and vaccine safety.
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