Originally Published IVD Technology May 2005
INDUSTRY NEWS
Notables
FDA’s Center for Devices and Radiological Health (CDRH; Rockville, MD) has issued a guidance and published a final rule that would classify drug-metabolizing enzyme (DME) genotyping systems as Class II devices. The guidance document provides information on 510(k) submission requirements, such as recommendations for performance validation and labeling. According to the document, such devices are those “intended for use in testing deoxyribonucleic acid extracted from clinical samples to identify the presence or absence of human genotyping markers encoding a DME.”
In December 2004, FDA approved the AmpliChip CYP450 genotyping test by Roche Molecular Systems Inc. (Pleasanton, CA) as a Class III device. Three days later, Roche asked FDA to reclassify it as a Class II product.
A research team at Sandia National Laboratories (Albuquerque) has developed a technique that uses laser beams to identify cancerous cells. The beam, which is shot through microchannels, is analyzed by an imaging spectrometer that can detect small changes caused by idiosyncrasies in the cells. Tests performed by the Sandia team have demonstrated the ability to identify early-stage liver tumor cells. According to the laboratory’s findings, 90–95% of the laser disturbances observed stem from mitochondria properties, which in the past were observable only through time-consuming fluorescent tagging.
A report released by the New England Healthcare Institute (NEHI; Cambridge, MA) in March predicts that continuous blood glucose monitors will “be highly valuable tools in managing diabetes within five years,” but advises industry to enact a number of steps to ease the acceptance of such devices in the healthcare community. The report cites statistics that only 37% of diabetic patients currently maintain proper blood glucose levels.
Although more-user-friendly devices hold the promise of improving patient acceptance, wider adoption will likely come only if FDA approves the devices as replacements for episodic monitoring. In addition, NEHI believes that broader coverage and reimbursement for continuous glucose monitors will need to be enacted, as will greater clinician and patient acceptance. Despite the benefits of the technology, industry will need to overcome a number of nontechnical obstacles as well, such as uneven access to health insurance and a lack of patient motivation. According to the report, the United States spends more than $70 billion each year to care for complications arising from diabetes.
Insulin-pump manufacturer Animas Corp. (West Chester, PA) has completed its purchase of Cygus Inc. (Redwood City, CA), maker of the only completely noninvasive glucose monitor approved by FDA, for $10 million. In the deal, Animas acquired the company’s intellectual property rights, production equipment, license agreements, and inventory.
Cygnus’s GlucoWatch Biographer, which remains the only completely noninvasive glucose monitor to be approved by FDA, has garnered considerable praise from industry but has been dogged by a number of technical glitches as well. Problems such as skin irritation and inaccurate readings have made it difficult for Cygnus to advance beyond the status of an adjunct diagnostic.
“Longer term, we are looking to substitute reverse electroiontophoresis extraction with microneedle extraction, using the microneedle technology that we recently licensed from Debiotech SA (Lausanne, Switzerland),” said Animas president and CEO Kathy Crothall, PhD, in announcing the acquisition. In recent filings with the Securities Exchange Commission, Animas discussed the possibility of such an amalgamation of technologies, nicknaming it the MicroWatch.
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