Biotech News Roundup: Aspen, AMAG, Vertex

BOSTON, Mass. (TheStreet) -- I've spent part of the last week attending the 2009 Canaccord Adams Global Growth Conference. Some notes from company presentations:

AspenBio Pharma(APPY) is a small diagnostics maker developing a simple blood test to allow emergency room doctors to quickly and easily diagnose appendicitis.

The Food and Drug Administration is reviewing the AspenBio test, known as AppyScore, under the 501(k) guidelines that regulate the approval of simple medical devices. AspenBio executives hope to get a first response from the FDA next month, but a final approval decision for the AppyScore lab test is more likely to occur in the second half of next year.

AspenBio spokesman Greg Pusey told me the company is mindful that updates on the FDA review of AppyScore are important, but Aspen won't commit to disclosing details of the initial FDA response next month.

The AppyScore data submitted to the FDA isn't blemish free. The pivotal study ran into problems last January when AppyScore's ability to accurately determine if a patient wasn't suffering from appendicitis (and therefore could be sent home from the emergency room safely) fell below expectations.

AppyScore's so-called "negative predictive value" improved when it was combined with standard blood tests, and improved further when AspenBio loosened the test's sensitivity.

AspenBio says its study design allowed for adjustments to be made and that FDA reviewers will find the changes copacetic. Of course, that is AspenBio's side of the story; the FDA hasn't weighed in yet.

Investors punished AspenBio last January. Shares fell from $7 to under $2 and have only recovered to around $2.50 recently, so the risk of an FDA rejection or significant delay is baked into the stock price to some degree.