INDUSTRY NEWS
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Kim Blickenstaff |
“There was a laundry list of issues” with the trials, says Kim Blickenstaff, Biosite’s chairman and CEO. “Basically, you had either methodological issues or outcome issues.”
Biosite announced the withdrawal—its first ever—on May 17. In an April 2005 earnings report, the device manufacturer acknowledged that FDA had raised questions regarding the results of the ongoing clinical trials. The company tried to fix the problems in the ensuing months before acknowledging that the best course is to start over.
Blickenstaff says “it took us time to finally conclude” that the methodological issues were insurmountable. In particular, Biosite “constantly kept coming back to that one fundamental issue of the sites having different protocols.” He points to the “different standards of care” at the 14 clinical sites in the United States as the primary roadblock: “Once we realized that that is something that could not be secured, then all other issues became secondary.”
The lack of a standardized method for diagnosing strokes was evident during the trials, Blickenstaff notes. Some facilities use CAT scans, some use MRIs, and others use a combination of these approaches, he says. The standard of care did not reflect the state of the art, “which is how we did our BNP [B-type natriuretic peptide] test” for heart conditions, he points out.
Biosite designed the clinical trials with these dissimilar standards in mind, says Nadine Padilla, vice president of investor relations. “We knew that care within hospitals was going to be different. We chose to allow for that in our trial, because we thought that was replicating real life. It may be that putting some boundaries or stricter protocols [in the trials] may be a better approach to use in terms of getting the diagnostic device approved.”
FDA wants to see more control in the clinical trials, Blickenstaff says. The company executive believes it is possible to have more standardized tests. “It takes more rigor, it takes more site selection,” he admits. However, the executive notes that inserting a biomarker is inherently difficult when the standard of medical care depends on variables such as the medical school one attended and protocols that differ from hospital to hospital and from region to region.
Biosite describes the portable Triage Stroke Panel as “the first rapid immunoassay blood test utilizing multiple biomarkers for use as an aid in the assessment and diagnosis of stroke.” The quick test looks for four biomarkers—BNP, MMP-9, S-100 beta, and D-dimer—that “we think are useful for detecting cerebral ischemia,” Blickenstaff says.
Biosite’s stock dropped between $5 and $7 in value after the initial SEC filing that referred to the FDA questions. It has been hovering in the $44 range since then. “Of course, the market reacted to the more cautious stance on the part of management toward the stroke product,” says Bruce Canna, a senior analyst who follows the company at Leerink Swann & Co. (Boston).
“That kind of regulatory snafu is really not the norm,” Canna says, but he credits Biosite for the ambitious capabilities of the stroke panel. “The submission itself was really quite unusual,” says the analyst. Given the unique nature of the device, Canna believes “it was going to be a tough filing, no matter what.”
Meanwhile, Biosite says it will forge ahead on redesigning the trials and resubmitting the FDA application for the stroke panel, which is already being used in Europe. Blickenstaff says the company will consult with “institutional leaders” involved in research and in working with “a lot of patients” in the disease populations.
Biosite expects to announce its plans at its next conference on investor guidance in late July, Blickenstaff says. Padilla says Biosite will determine whether any of the previous trial data are useful once the company has completed discussions with FDA. For its part, FDA declined to comment on the Biosite application.
