Rapigen Secures WHO Prequalification for Three pLDH-Based Malaria Rapid Diagnostic Tests

Original from: EIN Newswire

Rapigen, Inc., an in vitro diagnostics company specializing in rapid diagnostic tests, announced that three of its malaria rapid diagnostic tests (RDTs) — BIOCREDIT Malaria Ag Pf (pLDH), BIOCREDIT Malaria Ag Pf (pLDH/HRPII), and BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) — were officially added to the World Health Organization (WHO) Prequalification (PQ) product list on April 14, 2025.

With this listing, Rapigen becomes eligible for UN procurement channels and global public health supply programs.

WHO Prequalification is an internationally recognized certification program that evaluates whether medical products — including medicines, diagnostics, and vaccines — meet WHO standards for quality, safety, and performance. Products listed under WHO PQ are deemed suitable for public procurement by international agencies and are a key eligibility requirement for access to global health supply markets.

A particularly noteworthy aspect of this listing is that all three products are built on pLDH (Plasmodium lactate dehydrogenase) technology. The majority of malaria RDTs currently in widespread global use rely on HRP2 (Histidine-rich protein 2), a protein produced by Plasmodium falciparum as the primary diagnostic target. However, growing reports of pfhrp2/3 gene deletion mutations — documented in the Horn of Africa (Ethiopia, Eritrea, Djibouti), parts of South America, and Southeast Asia — have raised serious concerns about false-negative results in HRP2-based RDTs.

In response, WHO's Malaria Policy Advisory Group (MPAG) issued guidance in 2021 recommending that countries where pfhrp2/3 gene deletion prevalence exceeds 5% transition to non-HRP2-based diagnostic strategies. pLDH, an enzyme expressed across all Plasmodium species regardless of gene deletion status, has emerged as a critical alternative detection target — and is explicitly cited by WHO as the representative non-HRP2 antigen for such transitions.

The three WHO PQ-listed Rapigen products and their WHO Product IDs are:
• BIOCREDIT Malaria Ag Pf (pLDH) — WHO Product ID: 13192-160-00
• BIOCREDIT Malaria Ag Pf (pLDH/HRPII) — WHO Product ID: 13193-160-00
• BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) — WHO Product ID: 13194-160-00

The BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) test is capable of simultaneously detecting both P. falciparum and P. vivax, making it well-suited for deployment across a wide range of malaria-endemic settings. Additionally, the BIOCREDIT Malaria Ag Pf (pLDH) was directly utilized as a comparative diagnostic tool in a peer-reviewed, WHO-supported surveillance study on pfhrp2 gene deletions conducted across 100 health facilities in Tanzania (Scientific Reports, 2024), providing independent real-world validation of the product’s performance and operational reliability.

"This WHO PQ listing for three malaria products is a significant milestone that confirms Rapigen’s diagnostic innovation and quality standards on the international stage," said a Rapigen spokesperson. "Our pLDH-based platform represents a key solution to the expanding global threat posed by pfhrp2/3 gene deletions, and we are confident it will contribute meaningfully to improving access to accurate malaria diagnosis and advancing global public health."

Building on this WHO PQ achievement, Rapigen plans to accelerate its global business expansion, with a particular focus on malaria-endemic regions across Africa, Southeast Asia, and Latin America. The company will pursue this growth through international procurement mechanisms and national public health programs.

Source: Rapigen Secures WHO Prequalification for Three pLDH-Based Malaria Rapid Diagnostic Tests