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ImmunoIVD

ImmunoIVD

Stockholm, Sweden· Est.
immunoivd.com
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Private Company

Funding information not available

Overview

ImmunoIVD is a commercial-stage diagnostics company and a market leader in Europe for newborn screening assays targeting SCID, SMA, and XLA. The company leverages a proprietary qPCR-based platform, SPOT-it™, which offers a simplified, equipment-light workflow using pre-filled reagent plates, making it highly suitable for national screening programs. With products integrated into multiple European national screening programs since 2016 and screening over one million newborns annually, ImmunoIVD has established a strong commercial footprint. The company is privately held, emphasizes research-driven innovation, and maintains a focus on quality and customer support, as evidenced by its ISO certifications and ESG recognition.

ImmunologyNeurologyRare Diseases

Technology Platform

SPOT-it™ qPCR-based assay platform using pre-filled, ready-to-use reagent plates and plate-stacking technology. Designed for high-throughput newborn screening from dried blood spots, requiring minimal laboratory equipment and no liquid-handling automation or dedicated clean room.

Opportunities

Significant opportunity lies in the global expansion of newborn screening programs, particularly in Asia and other regions where adoption of SCID and SMA screening is growing.
The company's equipment-light, cost-effective platform is ideally suited for public health labs in developing markets.
Furthermore, the modular SPOT-it™ technology allows for the addition of new disease targets to the assay menu as screening panels evolve.

Risk Factors

Key risks include dependence on government policy and funding for newborn screening, which can be subject to change.
The company faces competition from other diagnostic methods and platforms, including emerging sequencing technologies.
Regulatory hurdles and lengthy adoption cycles in new geographic markets also pose significant challenges to growth.

Competitive Landscape

ImmunoIVD is a recognized market leader for SCID screening assays in Europe. It competes with other large IVD companies that offer newborn screening solutions, as well as laboratories that develop their own LDTs (Laboratory Developed Tests). Its primary competitive advantage is the unique, simplified workflow of the SPOT-it™ platform, which reduces complexity and cost for labs, unlike more equipment-intensive qPCR or NGS solutions.

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