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Biotech / Medical : QDEL - Quidel more quick diagnosis

QDEL 27.52

-2.2%

Nov 26 3:59 PM EST

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To: Robert Busse who wrote (372)	1/29/1997 8:34:00 AM
From: Mike Relyea	of 1693

Bob, I did see information about the BioStar/Biota flu test agreement that appeared in a 28 January 1997 PRNewswire article: Biota Holdings Selects BioStar to Develop Influenza Diagnostic. What I found interesting is the comment, "The test is being developed with the immediate goal of having a diagnostic available for evaluation of samples from Phase III clinical trials of Biota's influenza therapeutic product candidate, zanamivir or GG167, planned by Glaxo Wellcome for later this year." This implies that Glaxo Wellcome intends to proceed with Phase III trial for GG167 - good news. In fact, since the completion of Phase II trials, it's the first I've heard (hint) that Glaxo will proceed with Phase III. Quidel will develop its flu test incorporating its QuickVue(R) Generation III one-step technology and seek CLIA waived status (http://www.quidel.com/newsrels/previous/03x18x96.html ). The 28 January 1997 article says, "During feasibility testing, the BioStar/Biota prototype exhibited superior sensitivity in detecting influenza A and B, required fewer steps to administer and was quicker to use than currently available tests." "Fewer steps" leads me to believe the test will not qualify for CLIA waiver. Advantage: QUIDEL! The closer Quidel and Glaxo get to introducing a flu test and treatment, the more speculative interest will develop for Quidel's stock, since the market for a one-step CLIA waved influenza test will be huge. Let's hope Glaxo announces soon that it will proceed with Phase III trials for GG167. Quidel will probably follow with another progress update about the Glaxo Wellcome influenza diagnostic collaboration. Mike

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