Invivoscribe's Cancer Test Clears Europe's Toughest Regulatory Hurdle

SAN DIEGO, CA – March 26, 2026 – Global precision diagnostics leader Invivoscribe has successfully secured a critical certification in the European Union for its IdentiClone® Dx IGH Assay, a diagnostic tool for certain blood cancers. The assay received Class C certification under the EU's stringent In Vitro Diagnostic Regulation (IVDR), a significant achievement that underscores the company's regulatory prowess and positions it for continued growth in a rapidly evolving market.

The certification, granted by the EU-designated Notified Body BSI (Netherlands), confirms that the assay meets the highest standards for performance, quality, and safety for a high-risk diagnostic device. This approval marks Invivoscribe's second successful IVDR certification, signaling its adeptness at navigating one of the world's most demanding regulatory environments.

Navigating Europe's New Regulatory Gauntlet

The landscape for diagnostic device manufacturers in Europe has been fundamentally reshaped by the IVDR (EU 2017/746), which fully replaced the previous In Vitro Diagnostics Directive (IVDD). The new regulation introduces a far more rigorous, risk-based framework that demands extensive clinical evidence, robust quality management systems, and continuous post-market surveillance.

Under the old IVDD, a vast majority—nearly 85%—of in-vitro diagnostics could be self-certified by the manufacturer. The IVDR has inverted this model, with estimates suggesting that up to 90% of all IVDs now require independent assessment by a Notified Body. These devices are categorized from Class A (lowest risk) to Class D (highest risk). The IdentiClone Dx IGH Assay's classification as a Class C device places it in a high-risk category, reserved for tests that are critical in diagnosing life-threatening conditions and guiding crucial patient management decisions.

Achieving this certification is a significant hurdle that has challenged the entire industry. A major bottleneck has been the limited capacity of Notified Bodies designated to carry out these complex assessments. With fewer than two dozen NBs available to handle tens of thousands of applications, certification timelines can stretch from 13 to 18 months, causing significant delays and market uncertainty. Many companies have been forced to withdraw products from the EU market rather than undertake the costly and resource-intensive process of IVDR compliance.

Invivoscribe’s success in this climate not only ensures its product's continued availability but also provides a competitive advantage. It demonstrates a proactive strategy and a deep-seated commitment to quality that sets it apart as other manufacturers race to meet the May 2026 compliance deadline for existing Class C devices.

Advancing Precision in B-Cell Cancer Diagnosis

The IdentiClone Dx IGH Assay is a sophisticated molecular test that plays a vital role in the evaluation of patients with suspected B-cell lymphoproliferative disorders, such as certain types of leukemia and lymphoma. These malignancies are characterized by the abnormal proliferation of a single B-cell clone, which produces a population of cells with identical, or clonal, gene rearrangements in the immunoglobulin heavy chain (IGH).

Using a highly sensitive PCR-based method, the assay detects these unique IGH gene rearrangements from a patient's peripheral blood specimen. Identifying this molecular signature is a defining hallmark of B-cell cancers, allowing clinicians to distinguish a malignant process from a benign reactive condition. This level of precision is crucial for accurate diagnosis and for establishing a patient-specific marker that can be used to monitor for measurable residual disease (MRD) following treatment. Tracking MRD is a cornerstone of modern cancer care, as it helps predict the likelihood of relapse and informs decisions about therapeutic intervention.

Significantly, the IVDR-certified assay now includes integrated analysis software. This feature automates the complex process of data interpretation, delivering standardized and objective results. By minimizing inter-laboratory variability and subjective interpretation, the automated software enhances the reliability and reproducibility of testing outcomes. This standardization is a critical step forward, ensuring that clinicians and patients can have the highest confidence in the diagnostic information that guides life-altering treatment pathways.

A Strategic Victory in a Growing Market

This regulatory milestone is also a significant business victory, solidifying Invivoscribe's footing in the burgeoning European precision diagnostics market. The sector, valued at over US$4.7 billion in 2023, is projected to surge to nearly US$16 billion by 2030, driven by the rise of personalized medicine and an increasing prevalence of complex diseases like cancer. With oncology diagnostics representing the largest segment of this market, Invivoscribe is perfectly positioned to capitalize on this growth.

By being one of the first to market with an IVDR-certified IGH clonality assay, Invivoscribe gains a substantial first-mover advantage. Laboratories across the EU, seeking to ensure their own compliance, are likely to favor fully certified, off-the-shelf diagnostic kits over laboratory-developed tests (LDTs), which now face a similarly high regulatory bar under IVDR. This shift is expected to consolidate the market around compliant, high-quality commercial assays.

“Achieving IVDR certification for the IdentiClone Dx IGH Assay is a significant milestone for Invivoscribe and reflects decades of regulatory rigor, scientific excellence, and dedication to international standards,” said Jason Gerhold, Vice President of Global Regulatory, Quality, and Clinical Affairs at Invivoscribe. “This certification demonstrates our ability to meet the most stringent regulatory requirements and positions us to continue supporting laboratories and clinicians across the EU with high-quality, compliant diagnostic solutions.”

The achievement aligns perfectly with Invivoscribe's vertically integrated business model. For over three decades, the company has built a comprehensive ecosystem that includes developing and manufacturing standardized reagents, assays, and bioinformatics software. It also operates a global network of clinical laboratories, LabPMM®, which provides harmonized testing services for pharmaceutical partners conducting clinical trials. This end-to-end capability makes Invivoscribe an ideal partner for drug developers needing to co-develop and commercialize companion diagnostics, a field that increasingly demands robust and compliant testing solutions.

With commercial availability of the IVDR-certified assay anticipated by early April 2026, Invivoscribe is set to deliver a critical tool to European healthcare providers, reinforcing its mission of Improving Lives with Precision Diagnostics® and cementing its role as a leader in the global fight against cancer.