FDA declines to accept Biofield PMA

The Food and Drug Administration has asked Biofield of Roswell,GA, to resubmit a premarket approval (PMA) application for itsAlexa 1000 breast cancer diagnosis system. The FDA declined toaccept Biofield's PMA for the product due to what the agency calleddeficiencies in the design of multicenter clinical trials conductedto support the submission.

Alexa 1000 is a non-imaging-based device that uses electricalsensing technology to measure the proliferation of cancer cellsin the breast (SCAN 2/8/97). The company announced earlier thisyear that its PMA submission for the product had been grantedexpedited review status by the FDA.

On reviewing Alexa 1000's PMA, however, the agency had concernswith the way the clinical trials were designed, in particularregarding the algorithms used on the supporting data set. TheFDA advised Biofield to select a final algorithm and test it withan independent data set. The agency also advised that clinicaltrial designs include the impact of Alexa 1000 on patient management.

Biofield said it is evaluating its options in replying to theFDA's concerns. If additional clinical trials are required, theremay be delays in the approval process for Alexa 1000, althoughthe FDA has advised Biofield that a resubmitted PMA will continueto be considered under the expedited review policy.

The news hammered Biofield's stock, which dropped from $10.50a share on Feb. 27, the day the news was announced, to $4.75 ashare on Feb. 28. It was trading at about $6.50 last week.