A new generation of diagnostic tests, recently approved by the FDA, were created with the help of a technology patented by the National Institute of Dental and Craniofacial Research. Dr. Frank Robey, a senior investigator in NIDCR's Division of Intramural Research, developed a chemical procedure that facilitates the creation of complex, custom-designed peptides and peptide-based reagents. The method was licensed to Diatide Inc., a Londonderry, New Hampshire pharmaceutical company that is using the process to develop in vivo imaging tests and targeted therapeutics based on synthetic peptides linked to radioisotopes. One of the approved tests recognizes life-threatening blood clots and the other detects the presence of malignancy in lung masses that show up on routine chest X-rays.

Both of the test kits, AcuTectä for clots and NeoTectä for lung tumors, received FDA priority review status and were approved for use in humans in less than 12 months, reflecting the importance of this diagnostic technology in serving unmet medical needs. The company hopes that the new imaging tests will immediately help two groups of patients--those at risk of potentially fatal pulmonary emboli, and those who would normally require a biopsy to identify a lung tumor as benign or malignant.

"Dr. Robey's peptide technology unquestionably speeded up the discovery and development process for our diagnostic kits," said Dr. Richard Dean, CEO of Diatide. If we had relied on traditional chemical procedures, a small company like Diatide would not have had the resources to accomplish what we have done. This technology has definitely enhanced the rate of drug discovery."

A technique that can streamline the production of designer peptides has broad application throughout the biomedical sciences, according to Robey. "These two diagnostic kits are just the tip of the iceberg," he said. "This is an 'enabling technology' whose research and clinic
'"/>

Contact: Wayne Little
wayne.little@nih.gov
301-496-4261
NIH/National Institute of Dental and Craniofacial Research
17-Oct-1999