New 24-Hour Test Aims to Refine Advanced Cancer Treatment

LENEXA, Kan. – March 26, 2026 – Eurofins Viracor, a prominent name in advanced clinical diagnostics, today announced the launch of a new diagnostic tool that promises to sharpen the cutting edge of cancer immunotherapy. The ExPeCT™ anti-CD19 (obe-cel) CAR T-cell assay is designed to provide clinicians with critical data on a patient's response to a next-generation cell therapy, delivering results with unprecedented speed—approximately 24 hours from specimen receipt.

This rapid, non-invasive blood test is poised to have a significant impact on the management of patients undergoing CAR T-cell therapy, a complex but powerful treatment that engineers a patient's own immune cells to fight cancer. By offering a near real-time view of the therapy's performance, the assay could empower oncologists to make more timely and informed decisions, potentially improving patient outcomes.

A New Tool for a New Generation of Therapy

The ExPeCT™ assay was developed exclusively to monitor obecabtagene autoleucel, a groundbreaking CAR T-cell therapy marketed as Aucatzyl. Approved by the FDA in late 2024 for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), obe-cel represents a significant evolution in cell therapy design.

Traditional CAR T-cell therapies, while effective, can sometimes lead to severe side effects like cytokine release syndrome (CRS) and neurotoxicity, caused by an overstimulated immune response. Obe-cel was engineered to mitigate these risks. It features a unique CAR construct with a "fast off-rate" kinetic. This allows the engineered T-cells to bind to cancer cells, deliver a lethal blow, and then quickly detach to seek out another target. This process, which more closely mimics the natural function of T-cells, is designed to prevent T-cell exhaustion and reduce the intensity of the immune response.

Clinical data from the pivotal FELIX trial has supported this design philosophy, demonstrating durable remissions with remarkably low rates of severe CRS and neurotoxicity. As this sophisticated therapy becomes a new standard of care for a vulnerable patient population, the need for equally sophisticated monitoring tools becomes paramount. The new assay from Eurofins Viracor is designed to meet that need, providing a dedicated tool to track the unique dynamics of obe-cel in the body.

The Critical Need for Speed and Precision

The success of any CAR T-cell treatment hinges on two key factors: the initial expansion (or proliferation) of the engineered cells after infusion and their long-term persistence in the body to guard against relapse. A failure in either can lead to treatment failure. Historically, monitoring these dynamics has relied on methods like flow cytometry, which, while powerful, can be subject to variability and may not offer the rapid turnaround required for acute clinical decisions.

Eurofins Viracor's new assay addresses this gap by using a quantitative polymerase chain reaction (qPCR) technique. This molecular method directly measures the genetic signature of the obe-cel CAR T-cells circulating in a patient's blood, providing a precise count of the therapeutic cells. This direct quantification offers a clearer picture of the therapy's vitality than indirect markers, such as monitoring the depletion of healthy B-cells.

The most significant advantage, however, is speed. Receiving a precise quantitative result within approximately 24 hours can be transformative. For a patient whose CAR T-cells are not expanding as expected, this early warning could allow clinicians to consider interventions like bridging therapies or planning for a subsequent treatment, such as a stem cell transplant, far sooner than previously possible. Conversely, for patients responding well, the data provides crucial reassurance and helps guide long-term follow-up strategies.

A Strategic Move in a Multi-Billion Dollar Market

The launch of the ExPeCT™ assay is not just a clinical advancement; it is a calculated strategic move by Eurofins Viracor and its parent company, Eurofins Scientific, a global bio-analytical testing giant. The CAR T-cell therapy market is one of the fastest-growing sectors in oncology, with market valuations projected to surge from around $4.3 billion in 2024 to over $60 billion by 2034.

Within this booming market, CD19-targeted therapies like obe-cel are dominant. By developing an exclusive monitoring assay for a newly approved, high-potential therapy, Eurofins Viracor carves out a vital and defensible niche. This strategy aligns perfectly with Eurofins Scientific's broader focus on personalized medicine and specialized diagnostics. As treatments become more individualized and complex, the demand for companion and complementary diagnostics that can guide and optimize these therapies skyrockets.

This assay positions the company as an essential partner for medical centers administering obe-cel, embedding its diagnostic services directly into the treatment pathway for this advanced therapy. It demonstrates an agile response to market innovations, ensuring that as new, complex therapeutics are approved, the diagnostic infrastructure needed to support them is ready. This symbiotic relationship between therapeutic and diagnostic development is becoming a hallmark of modern oncology.

Unpacking the Diagnostic Technology

At its core, the ExPeCT™ anti-CD19 (obe-cel) assay is a highly sensitive molecular test. The multiplexed qPCR technology targets the unique transgene sequences of the obecabtagene autoleucel CAR, ensuring that it specifically detects and quantifies only the therapeutic cells. The company has stated the assay is validated for its precision, accuracy, and sensitivity, making it a reliable tool for longitudinal monitoring.

This allows clinicians to track the entire lifecycle of the therapy within a patient, from the initial engraftment and peak expansion in the days and weeks following infusion to the long-term persistence phase months or even years later. Having a standardized, validated test provides a consistent benchmark for assessing patient response, a crucial factor when managing therapies with such high stakes and costs.

By providing a direct and quantitative measurement of the therapeutic "drug" itself—the living CAR T-cells—this technology marks a step forward from relying solely on clinical symptoms or indirect biological markers to infer treatment efficacy. This level of precision is fundamental to the promise of personalized medicine, where treatment is continuously tailored to an individual's unique biological response. As the arsenal of cell and gene therapies expands, such precise and rapid monitoring tools will become not just beneficial, but indispensable for delivering on the full potential of these revolutionary treatments.