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Wire · opportunities

BGI Genomics Nabs CE-IVDR Certification for NIFTY Noninvasive Prenatal Test

13 August 2026 · By · Wire by Fusion42

Published

13 August 2026

Topic

opportunities

◆ Sectors

Biotech

◆ Geography

Europe

◆ Source

Read at genomeweb.com →

◆ Verified

Fusion42 · 13 August 2026 · Fusion42 review

BGI Genomics has received CE-IVDR certification for its NIFTY noninvasive prenatal test, allowing broader compliance and market access in the European Union under the new In Vitro Diagnostic Regulation.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ ◆ The Wire takeaway

You gain a clear path to enter or expand in the EU diagnostics market as CE-IVDR certification now validates your prenatal test. Investors and partners will expect you to leverage this compliance to accelerate growth in European healthtech.

◆ Coverage

1 source · 13 Aug 2026

◆ Related on Wire

◆ Topics

Biotechce-ivdrprenatal-testingregulatory-approvalgenomicsbiotech