FDA News

IRIS to Proceed with New FDA 510(k) Pre-Market Notification for NADiA PSA After FDA Discussions

(July 29, 2008)-- IRIS International, after extensive consultation with the US Food and Drug Administration (FDA), intends to resubmit its 510(k) for its NADiA PSA (Prostate Specific Antigen) ultra-sensitive diagnostic test with a prognostic claim. Following FDA advice, IRIS has already submitted a request for a Pre-Investigational Device Exemption meeting (Pre-IDE Meeting), an optional process through which the applicant consults with the FDA for the purpose of improving the quality of submissions and to shorten review times. IRIS will submit a new 510(k) seeking clearance of a prognostic claim for identifying post-prostatectomy patients with low-risk of prostate cancer recurrence, with an estimated timeline for anticipated market introduction in the first half of 2009, it was announced by César García, Chairman, President and CEO of IRIS International.

“We are particularly pleased with our discussions with the FDA. This investigational diagnostic test, we believe, represents a potential major contribution to medicine that will result in improved patient care and comfort at significant healthcare savings,” Mr. García stated.

“Following discussions with the FDA regarding the optimal regulatory pathway, we recently submitted a request for a Pre-IDE Meeting with FDA to obtain FDA’s feedback on a protocol on a clinical study we are planning which, when concluded, will be used to support the filing of a new 510(k) submission. The new 510(k) submission will seek clearance for a prognostic claim for the NADiA™PSA as an in-vitro diagnostic assay intended to be used in conjunction with clinical evaluation as an aid in predicting risk for recurrence of prostate cancer after radical prostatectomy. We have maintained continuous communication with the FDA over the last several months, and the pre-IDE meeting should formalize the collaborative review process via written feedback on the protocol and intended use claims from the FDA prior to initiating the study, significantly reducing interpretation risks by either party. We have been notified by the FDA that the Pre-IDE review meeting will be held in August 2008,” Mr. García said.

“All of the data submitted in our original 510(k) in February 2007, will be carried-over to the new application. The FDA has already reviewed the analytical performance of our NADiA PSA assay and conveyed to us that clearance through the 510(k) process is a viable option depending upon the results of a new clinical study, the protocol of which will be discussed at our scheduled pre-IDE meeting with FDA. We believe that clearance of the prognostic claim in the new submission for NADiA™ PSA would enable the stratification of post-prostatectomy patients and is an enhancement of the claim covered by our initial 510(k) submission. Such a breakthrough in the monitoring of prostrate cancer relapse should result in better therapeutic outcomes and avoiding potentially unnecessary procedures and treatments,” added Mr. García.

“IRIS has organized a medical advisory committee consisting of experts in clinical urology, oncology and healthcare reimbursement that are advising the Company about the potential impact of NADiA PSA in improved patient treatment and comfort, reduced morbidity and lowered health care costs. Due to these potential benefits, we feel that NADiA PSA should command a significantly higher reimbursement,” said Dr. Thomas Adams, Corporate Vice President and CTO of IRIS.

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