APROGENEX' ONE-STEP GENSITE DNA PROBE TEST DIAGNOSES UP TO 95%

APROGENEX' ONE-STEP GENSITE DNA PROBE TEST DIAGNOSES UP TO 95% of the most common prenatal genetic abnormalities, the Houston-based startup says in a recent prospectus filed with the Securities and Exchange Commission. Using a maternal blood sample, GenSite tests can detect both "the sex of the fetus and approximately 95% of the most common prenatal birth defects," Aprogenex claims, including "Down Syndrome, Edward Syndrome, Patau Syndrome, Kleinfelter Syndrome, XYY Syndrome, Triple X Syndrome, and Turner Syndrome." Results are available on a same-day basis. GenSite products are part of a family of planned diagnostic probes based on Aprogenex' RIGHTechnology (rapid intact gene hybridization technology). The GenSite test includes synthetic DNA probes manufactured by the company and labeled with fluorescent or enzyme molecules, and a proprietary "cocktail" solution that renders the membranes of the target cell and nucleus permeable to the probe. In a one-step process, "the cocktail is applied to the subject cells which are then heated for a specified time," the prospectus explains. The targeted DNA strand in the heated cell unwinds, allowing the probe to enter and bind to the targeted nucleic acid. "The targeted cell is then cooled," and the unbound probes are washed away. "Preclinical results indicate that the company's proprietary technology will enable the customer to perform multiple, simultaneous tests for different genes within the same cell and within the same solution," Aprogenex says. The company is positioning GenSite as a non-invasive, "definitive" means of prenatal genetic screening, "mitigating" the need for invasive procedures such as amniocentesis and chorionic villi sampling. Aprogenex also details several advantages of its RIGHTechnology over current DNA probes. For example, Aprogenex probe tests can be performed in 30 minutes to three hours, the company says, compared with up to two weeks for other probes. The Aprogenex tests also are highly sensitive, the firm says, "capable of detecting DNA or RNA at the single copy level without cumbersome and time- consuming target or signal amplification technology." GenSite probes for the identification of fetal cells in maternal blood and identification of genetic disorders in fetal cells currently are undergoing clinical investigation. Aprogenex expects to submit an initial 510(k) "substantial equivalence" application to FDA by the end of this year. The company says it will initially target the test to genetics laboratories, and expects to offer its "fetal cell identification and genetic disorder screen at a combined price ranging from $75 to $100 per test." Long-term plans include possible collaborative arrangements with other diagnostic firms for R&D, distribution and/or licensing, Aprogenex says. In June, Aprogenex licensed its prenatal genetic testing technology to laboratory firm Dianon under an agreement which allows Dianon to use the technology to conduct investigations under its own protocols, the prospectus notes. Dianon in turn made a $700,000 equity investment in Aprogenex. Under the terms of the license, Dianon can only use the technology to analyze samples in its U.S. labs; once Aprogenex receives FDA approval to commercialize the technology in GenSite kits, the license becomes non- exclusive. "Dianon will purchase materials from the company and other suppliers and Aprogenex will receive a royalty on services offered by Dianon," the prospectus adds. The filing registers 1.5 mil. Aprogenex shares for sale in an initial public offering, underwritten by H. J. Meyers & Co. Assuming a sale price of $11 per share, Aprogenex expects to net $14 mil. from the stock offering. The company will allocate $4 mil. of the proceeds to R&D, including regulatory activities, $2 mil. to marketing and $1 mil. to the purchase of equipment. Aprogenex was founded in 1989 by President and CEO Joel Bresser, PhD, who developed the RIGHTechnology at M.D. Anderson Hospital in Houston. Bresser, in the past, has served as a consultant to Amersham and GeneTrak, the prospectus notes. Aprogenex Vice President for Business Development and Marketing Terry Ryusaki is a Baxter alumnus; positions there include director of marketing and customer operations for Baxter's Stratus immunochemistry division. In addition to GenSite, Aprogenex is developing a number of other DNA probe test systems. The KaryoSite test, designed to identify prenatal genetic disorders in amniotic fluid, in vitro fertilization, bone marrow, peripheral blood, and chorionic villus samples, is in clinical trials. The company also is developing probes for human papilloma virus and a viral load test for HIV.