Excerpt from a Citigroup analyst report on Biogen. Anyone heard boo from their Neuro when we might be tested?

"STRATIFY-1 Trial Needed to Confirm STRATA Retrospective Analyses

The STRATIFY-1 trial is enrolling 1,000 new or existing patients. The trial is conducting both urine and serum testing every year for a period of 2 years. The test is essentially being used to confirm the retrospective findings of the STRATA study. Recall that retrospective analysis of this study led to confirmation that the JCV antibody assay can detect patients that have been exposed to the virus with a false negative rate of only 2.5%. The trial is collecting urine samples to determine the false negative rate of the assay in a prospective setting. This is because patients who shed viral DNA in the urine are considered to have been exposed to JCV. Thus, the analysis of blood with the JCV assay should be able to confirm that these patients are positive for the virus.

STRATIFY-2 Testing How JCV Can Determine Risk of PML Development

The STRATIFY-2 trial is testing the assay in patients who are currently on Tysabri or who are new to the drug and is expected to enroll ~8,000-25,000 patients. There is no fixed length of time for STRATIFY-2 and only serum samples are being collected every year for a minimum period of 2 years. The purpose of STRATIFY-2 is to determine what is the PML risk in patients who test negative in the JCV antibody test. Neither STRATIFY-1 nor STRATIFY-2 are being mandated as part of the TOUCH program. There is nothing in the protocol of these studies about treatment decisions if the patient is positive or negative for JCV antibodies. The powering of the study is difficult to determine, because it depends on how many patient get tested and how many patients get PML. Data disclosure remains to be determined. Biogen Idec intends to share the data with regulatory agencies in order to
eventually get language into the label in regards to the risk of PML in patients who are positive or negative for JCV antibodies.

Enrollment in STRATIFY-1/2

The pace of enrollment in STRATIFY-1 & 2 is dictated by site activation. Currently more than 250 patients have already enrolled in STRATIFY-1 and enrollment is also going well in STRATIFY-2. The test is expected to be
eventually available in 100% of the centers enrolled in the TOUCH program. There are many registries ex-U.S. interested in the PML assay, but STRATIFY-1 & 2 are being conducted exclusively in the U.S.


Commercial Availability of the PML Assay

There is a path in mind to commercialize the PML assay. However, the lab company has not gone public with its plans thus far. The availability of the assay will also differ between regions because of different requirements among them. There is a lower hurdle to get the test approved as a JCV antibody assay compared to a validated assay that can help determine the risk of PML. The price of the assay, when it becomes commercially available, has not yet been determined. However, this test is fairly standard and is routinely reimbursed by payers. "