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WHO Invites Manufacturers to Submit Diagnostic Tests for Ebola Bundibugyo Virus for Emergency Use Listing (extranet.who.int)

· 59d ago · Report · Spotlight this ·
0xBASE INTEL BRIEF
  • PHEIC declared for Ebola Bundibugyo in DRC and Uganda on 17 May 2026.
  • WHO seeks manufacturers of nucleic acid detection IVDs for BDBV for Emergency Use Listing.
  • EUL requirements: ISO 13485, high manufacturing capacity, affordable pricing (<$5/test).
  • Listing valid for 12 months, renewable; public reports on outcomes will be published.

"Following the declaration of a PHEIC on 17 May 2026 for Ebola Bundibugyo in the DRC and Uganda, WHO has opened an Expression of Interest for manufacturers of nucleic acid detection IVDs. Manufacturers must have ISO 13485 certification and high production capacity; pricing under $5 per test is desirable. The EUL listing is valid for 12 months and aims to expedite availability for UN procurement. Applications require a pre-submission meeting with WHO."

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