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Executive Summary

BAXTER SURVEYING CAMBRIDGE BIOSCIENCE RECOMBIGEN HIV TEST BUYERS to determine the conditions under which the test is being used. Baxter, which sells the Recombigen AIDS antibody screen under a license from Cambridge BioScience, is conducting the survey as part of an effort to respond to questions raised by Rep. Wyden (D-Ore.) regarding the firm's marketing of the kit. Wyden, who chairs the House Small Business Committee's subcommittee on regulation and business opportunities, wrote Cambridge BioScience and Baxter on March 24 requesting information about Baxter's marketing practices. The letter was sent one day after it was revealed at a subcommittee hearing that Recombigen had been used in homes. The AIDS antibody test is labeled for professional use only. In the March 24 letter, Wyden asked whether there is "a detailed written agreement . . . between Baxter and Cambridge BioScience regarding the market (i.e. customers) to be pursued for sales of the kit?" He also requested information on any "self-imposed limitations . . . regarding who may or may not be sold the test." Wyden also asked if either of the two firms "track ultimate use" of the tests. "Specifically, do the companies take pains to ensure that the tests are not resold by customers to other users? Do the companies monitor to make sure that the tests are used in the environments intended in the sales agreements?" Wyden noted that in addition to the reported use in homes, the test was sold to a Florida lab that recently was shut down by state authorities. According to the congressman, the receptionist in the lab told Wyden's staff aides that she had been trained how to use the test. As a result of that discovery, Wyden asked Cambridge BioScience and Baxter whether they make sure that the people who perform the test are properly trained. In addition, he wondered whether the firms ensure that the individuals performing the test are health care professionals. Baxter and Cambridge BioScience are preparing a joint response to Wyden's March 24 letter. In an earlier letter to Wyden, Cambridge BioScience Chairman and CEO Gerald Buck emphasized that Recombigen is not a home test. Buck said that the test "is designed for use by properly trained professionals in the health care system, and is not available for sale except to qualified health care providers." Buck also noted that under the marketing agreement with Baxter, "Baxter has the obligation, among other things, to comply with requirements established by [FDA]. We are informed by Baxter that it is selling the latex agglutination test only to professionals in the health care system. It is of course in our interest that this be so, for it is important that the test be properly used by trained personnel; as with any test, poor technique or failure to follow the manufacturer's package insert instructions can give bad results."

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