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News. It's what's up.

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MALARIA UPDATE TO DONOR SCREENING GEO GUIDE

July 5, 2024

During routine monthly review of the CDC’s online Yellow Book, revised malaria information for Iran and Guatemala was discovered. In the case of Iran, recent outbreaks were reported in the province of Sistan-Baluchestan, near the border with Pakistan. Since anti-malarial chemoprophylaxis is now recommended for this area, Iran is no longer classified as non-malaria-endemic. This change warrants an update to the GEO Guide, and work will begin immediately on this.

 

As for Guatemala, the department of Quiche has been removed from the areas with malaria and chemoprophylaxis recommendations. This change will also be incorporated in the current update to be issued on July 5, 2024.

UPDATE TO TISSUE DONOR SCREENING GEO GUIDE

June 4, 2024

Last month the FDA determined that Zika virus is no longer a “relevant communicable disease agent or disease” for human cell, tissue, and cellular & tissue-based products. This coincided with the CDC archiving it’s previous version of the Zika interactive map and launching a new map on this page: https://www.cdc.gov/zika/geo/index.html

 

When recently reviewing the CDC's new Zika map and the countries listed, it appears that the Zika status for France and Corsica has been downgraded and the Zika status for Mali has been upgraded. For tissue programs that have not yet discontinued Zika screening, these changes (particularly the change to Mali) are relevant.

 

To serve our users that are still screening their tissue donors for Zika Virus, an update will be issued by June 7, 2024.

FDA RECLASSIFIES ZIKA VIRUS AS NO LONGER A "RELEVANT COMMUNICABLE DISEASE AGENT OR DISEASE" FOR HUMAN CELL, TISSUE, AND CELLULAR & TISSUE-BASED PRODUCTS

May 22, 2024

The FDA has determined that Zika virus is no longer a “relevant communicable disease agent or disease” for human cell, tissue, and cellular & tissue-based products. Here is a link to the announcement on the Tissue Guidances page of the FDA’s website: Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Communicable Disease Agent or Disease.

 

This determination means that tissue donor screening is no longer recommended by the FDA for Zika Virus. As a result, the Zika Virus section of the Tissue Donor editions of the Donor Screening GEO Guide will be retired as part of a future update. This change is not being issued as an immediate update to allow our Tissue Donor edition users to implement this change on their individual timelines.

FDA APPROVES FIRST MALARIA TEST FOR BLOOD DONORS

March 20, 2024

The FDA approved Roche's screening test to detect malaria in blood donors. This approval marks a major milestone in the screening of blood donations for malaria. Get more specifics on the FDA's website here.

The shift from donor travel screening to blood testing for malaria screening will bring significant benefits. We can reasonably expect fewer donors being deferred for malaria, due to the more specific nature of blood testing.

This new malaria screening method will make most of the content of the GEO Guide obsolete, therefore publication of the GEO Guide will conclude when all of our clients have successfully implemented testing.

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2024 UPDATE SUBSCRIPTION PRICING RELEASED

February 15, 2024

Donor Screening GEO Guide subscription pricing for the 2024 term (from April 1, 2024 through March 31, 2025) has been determined.

​Subscription pricing remains the same as for 2020, 2021, 2022, and 2023.

 

Update projections for 2024 included consideration of the following factors:

  • Possible changes in malaria-endemic areas in 9 countries, potentially affecting 14 maps (with an estimated 7 overlays impacted) based on analysis of the 2023 WHO World Malaria Report.

  • Possible publication of revised FDA tissue guidance on vCJD.

  • Possible changes in Zika risk countries.

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