First FDA-approved NAT Solution

The PROCLEIX^® WNV Assay is the first NAT solution approved by the FDA for the direct detection of the West Nile virus in plasma specimens from individual donors and is now CE marked!

PROCLEIX^® WNV Assay is the leading WNV NAT assay worldwide because of its superior performance, fast turnaround of less than 5 to 6 hours, and flexibility to run in single donor or pools of up to 16. The assay is proven to detect low-level virus than any other NAT, and detects WNV Lineage 1 and 2 with comparable sensitivity¹. Excellent specificity means fewer false positives and fewer deferred or lost donors.

 

Early detection of West Nile virus for blood screening

In late 2002, FDA asked manufacturers of blood screening technologies to create a test that could effectively screen donations for WNV. Novartis Diagnostics and its partner, Gen-Probe developed a nucleic acid test (NAT) specific for WNV RNA in just nine months – half the usual time for developing a new assay.

In June 2003, the PROCLEIX^® WNV Assay was implemented by blood centers across the U.S. to screen blood, tissue and organ donations under an FDA-approved Investigational New Drug (IND) protocol. US blood centers have screened more than 29 million blood donations with the assay and intercepted more than 1,500 positive WNV donations.

Implementation of WNV NAT has protected patients who receive blood and other such products against West Nile infection. To date, there have been 30 documented cases of people who most likely acquired WNV from a blood transfusion, including nine who died.

With FDA approval on December 1, 2005, the PROCLEIX^® WNV Assay can be used in routine testing.

 

West Nile Virus without boundaries

In preparation of the risk to regional blood supply due to WNV, several countries outside of the U.S. have developed their own WNV preparedness plans in the event a similar epidemic is observed in their country. Additionally, some countries have observed significant donor loss due to donor deferral of travelers visiting the U.S. during WNV season. For these reasons, the PROCLEIX^® WNV Assay has been evaluated in countries like Canada, Mexico, France, Netherlands and Japan. The advantage of the PROCLEIX^® WNV Assay is that it can be added to current workflow utilizing the same equipment as other PROCLEIX^® Assays, thus reducing additional capital cost.

The PROCLEIX^® WNV Assay is now available in various languages, including French, Spanish, German, Portuguese and Italian for immediate use on either the semi-automated PROCLEIX^® System (eSAS) or fully automated PROCLEIX^® TIGRIS^® System. For more information, please contact your local sales representative.

PROCLEIX is a trademark of Novartis Vaccines and Diagnostics, Inc.
Developed by Gen-Probe in collaboration with Novartis Vaccines and Diagnostics, Inc. Manufactured by Gen-Probe Incorporated. Distributed by Novartis Vaccines and Diagnostics, Inc.

 

References

1. Busch MP, et al. Transfusion. April 2005. 45:492-499.