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Executive Summary

ORTHO HAS OPTION AGREEMENT FOR OTC HOME-USE TEST being developed by Personal Diagnostics Inc. While specific details on the OTC test are not being disclosed, Personal Diagnostics said Jan. 6 that it "expects that, if successful, further and more definitive agreements covering the commercialization of the product will be forthcoming." The option agreement is with Ortho's Advanced Care Products Division. The test is in the development stage. Personal Diagnostics is a diagnostic product company founded in 1980. It went public with a $2.1 mil. offering in 1981 and a secondary 1 mil. share offering in 1982. The company was working on a fertility prediction system (Ovaplan) for home use and a selfcare blood glucose test with Stauffer Chemical. That cooperative effort was cancelled during Personal Diagnostics' fiscal year which ended Sept. 30. Personal Diagnostics President John Toedtman stated: "The company has been actively seeking additional partners since termination of the Stauffer contract in August 1985. Due to the lack of external funding of R&D, the results for the fiscal fourth quarter and the first quarter of fiscal 1986 . . . have been adversely impacted since the development of its proprietary products has continued with internal funding." For the year, Personal Diagnostics reported a loss of $761,000 on sales of $9.2 mil. Personal Diagnostics has been working on home test systems for strep throat and urinary tract infections. In 1983, the company described the strep and urinary tract infection projects as relying on a incubating kit for specimens, called Incupaks. The kits "are entirely disposable devices designed to register the presence of an infection without the need for laboratory testing," Personal Diagnostics said. "The patient obtains a specimen (for example, of urine) in a specially designed cuvette. The cuvette is placed in the Incupak, in which the specimen is incubated by the Incupak's self-contained heating source, to encourage growth of infectious bacteria, if any. After four hours, the presence or absence of clinically significant infection is confirmed by transmitting light through the cuvette to an optical detector."

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