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Executive Summary

MEDICAL FRONTIERS LAUNCHES OTC SPECIMEN COLLECTION KIT FOR GONORRHEA in men, the VD Alert, in "selected stores" in Washington, D.C., Delaware, Maryland, New Jersey, Virginia, West Virginia, Ohio, Kentucky, Tennessee, Indiana, Illinois, Michigan and California, the company announced Aug. 15. The initial rollout is scheduled to begin in September.Nationwide marketing of the test will be phased in through "a number of expansions throughout 1985," a company official said. The VD Alert is being offered to chain drug stores and wholesalers in six-packs, which include a point-of-purchase display. Individual kits are expected to retail for $15 to $19.20, the official said. The Centerville, Ohio company said it has "firm commitments" from Rite Aid, Stop and Shop subsidiary Medi Mart, and Begley Drugs to test market the VD Alert. "Beginning in September, the in-home test will initially be available to consumers in 200 Rite Aid stores, 60 Medi Mart, 52 Begley Drugs and other various regional drug store chains," Medical Frontiers stated. "Negotiations with additional drug chains are currently in progress." Medical Frontiers said it also has "firm purchase order agreements from six major regional wholesale drug chain distributors." Commenting on the VD Alert, Medical Frontiers President Michael Sicherman said, "While there are many companies presently engaged in research and development of products related to sexually transmitted diseases, no other in-home STD diagnostic product of significance currently exists. We are optimistic about the potential of this new product." Men who use the VD Alert, a presumptive test for the bacterium that causes gonorrhea, will send the in-home sample to Medical Frontiers' CDC Interstate Commerce-approved laboratory for diagnosis. A confidential analysis of the test results will be provided by calling a toll-free number with a personal identification code, the company explained. Package information advises men to see a doctor immediately if the test results are positive. If results are negative but symptoms persist, users also should see a physician, the company says, as the symptoms may indicate other diseases. Medical Frontiers claims its test has 95% specificity. The company is meeting with state and federal officials to discuss reporting requirements for venereal disease cases, a Medical Frontiers official said. He explained that while the company is prepared to provide statistics on its gonorrhea test results, it has strong concerns about providing names and addresses of its customers. In addition, the spokesman noted the potential for double reporting by Medical Frontiers and a customer's personal physician. The VD Alert was cleared for marketing by FDA in May 1982, based upon its similarity to another self-collection kit for identification of gonorrhea in men, the GSK/M, manufactured by Biomedical Innovations, Inc., of Chicago, an FDA spokesman said. BMI, which since has ceased operations, never took its OTC product to the market. However, the company was responsible for getting FDA to reclassify the self-collection gonorrhea test kit from Class II "premarket approval" to Class I "general controls." According to the FDA official, a third test "for virtually the same thing" was cleared for sale earlier this year. That test, developed by a New York physician for use in his own clinical practice, reportedly is intended for use primarily in the New York metropolitan area. Medical Frontiers is an outgrowth of Internatl. Research Distributors, a smaller, private company founded by Sicherman and N.K. Jack Hickman. The company changed its name to Medical Frontiers in December 1982, and went public in July 1983 via a 4 mil. share offering at 50 a share. The VD Alert is Medical Frontiers' first commercial product. Research and development of additional diagnostic tests in the venereal disease area currently is underway, the official said.

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