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Verax files 510 (k) for 2 additional platelet types, also modifies current product labeling

If cleared by the FDA, Verax Biomedical would offer the only day of transfusion test for all FDA approved platelet types; positions PGD for broader use

December 1, 2014

MARLBOROUGH, Mass.-- Seeking to expand their day of transfusion platelet testing capability to include all FDA currently approved platelet types, Verax Biomedical has filed a 510 (k) for additional claims for its Platelet PGD Test, the company announced today.

The Verax filing seeks to expand the product's current claims to include platelets stored in Additive Solution (PAS) and Pre-Storage Pooled (or Acrodose™) platelets. If cleared by the FDA for these platelet types, this would make Verax Biomedical's Platelet PGD Test the only day of transfusion test validated for all FDA approved platelet types currently transfused in the United States. The test is already the only day of transfusion bacterial detection test cleared by the FDA with a Safety Measure claim which was validated with clinical population performance data.

"We're very pleased to successfully conclude these key studies and make this filing" said Jim Lousararian, CEO of Verax. "While PAS platelets and Pre-Storage Pooled platelets represent a small portion of the platelet inventory today, this filing positions us to have a testing solution for these critical components of the platelet inventory going forward as the use of these platelet types expands."

The filing follows on the heels of a change in the Platelet PGD Tests package insert that allows it to be used through the expiration date of the platelet being tested. The labeling previously limited use of the test to platelets dated 5 days or less. This label change has already been implemented, opening the door to use of PGD on platelets with dating greater than 5 days if or when the FDA chooses to allow an extension of platelet dating beyond the current 5 day limit.

"When the FDA initiated the discussion on this labelling change we were happy to engage" said Nancy Hornbaker, Verax's VP of Regulatory Affairs. "The blood banking community has long desired an extension of platelet dating beyond 5 days to address logistic and supply issues and PGD is well positioned if platelet dating is ever extended beyond the current 5 day limit."

The Verax Platelet PGD® test is a rapid immunoassay that detects antigens present on the surface of bacteria. It is used at the point of care, usually a hospital transfusion service laboratory, within 24-hours of transfusion when bacteria, if present, will be at higher levels and of greatest danger to patients. The test was cleared by FDA in 2007 for detecting bacterial contamination in leukoreduced apheresis platelets and in 2009 for use with whole-blood derived platelets. In 2011, the FDA cleared the test as a "Safety Measure" for leukoreduced apheresis platelets. All other bacterial contamination tests for platelets currently cleared by the FDA are cleared only as Quality Control tests.

In the United States, more than 85 percent of platelets transfused are collected via apheresis, an automated process by which one or more doses of platelets are collected from a single donor. Most are suspended in plasma, but a small but increasing portion of the US platelet inventory is suspended in additive solutions as well. The remaining platelets used for transfusion are primarily collected from whole blood donations, a manual process in which a partial platelet unit is collected (along with other blood components) and pooled from four to six different donors to generate a therapeutic platelet dose. These can either be pooled 4 hours before transfusion or pooled prior to storage.

About Verax
Verax Biomedical Incorporated is a developer of rapid tests for detecting bacterial contaminants in blood cells and tissue. The privately held company was founded in 1999. Its headquarters and laboratory facilities are located in Marlborough, Massachusetts.

Contacts
Verax Biomedical
Joe Sanders
Sr. VP Marketing and Business Development
JSanders@veraxbiomedical.com
617-771-8199

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The PGD testing system

The Company's first product is the Platelet PGD Test – a rapid test for the detection of bacterial contamination in platelets.

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