Viracor Eurofins' Algorithms Predict Risk of aGVHD and Non-relapse Mortality in Allogeneic HCT Patients

LEE'S SUMMIT, Mo., Aug. 8, 2018 /PRNewswire/ -- Viracor Eurofins today announced the launch of the first commercially available predictive acute Graft versus Host Disease (aGVHD) algorithms to help identify at-risk patients. Acute GVHD is a major complication following allogeneic hematopoietic cell transplantation (allo-HCT). Accurate and early identification of patients at high-risk for severe aGVHD and related complications has the potential to improve patient outcomes; high-risk patients can be preemptively treated for aGVHD prior to the onset of clinical disease, while low-risk patients may potentially avoid unnecessary treatment.

Viracor's newly licensed aGVHD Algorithm testing — utilizing the Mount Sinai Acute GVHD International Consortium (MAGIC) algorithm — was developed by Drs. James Ferrara and John Levine, both professors of Pediatrics, Medicine, Hematology and Medical Oncology at The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai, and validated in conjunction with 17 hematopoietic cell transplantation (HCT) centers. The aGVHD predictive algorithms utilize serum levels of ST2 and Regenerating islet-derived 3-alpha (REG3α) biomarkers, which are interpreted through the MAGIC algorithm using clinically validated cutoff values specific to the time of sample collection and/or the patient's condition. While there are multiple clinical factors that increase the risk of non-relapse mortality (NRM) post-transplant—including HLA mismatch, non-family donors, recipient age and GVHD prophylactic therapy—use of these predictive algorithms has been demonstrated to be accurate despite variations in these clinical factors.

"Viracor Eurofins has a proven history of launching innovative tests such as the aGVHD algorithms, to help healthcare providers improve outcomes for transplant patients. In 2013, Viracor launched a series of GVHD biomarkers, and now we're excited to further help physicians of HCT patients by providing these clinically-validated algorithms to predict the risk of NRM and severe aGVHD. We are committed to developing high quality assays that help our clients help more patients," said Steve Kleiboeker, PhD, HCLD/TS/CC (ABB), Vice President of Research and Development, Viracor Eurofins.

Prior to the development of these predictive algorithms, diagnosis of aGVHD relied almost entirely on the presence of clinical symptoms in one or more of the main target organs (skin, liver, gastrointestinal tract), with subsequent confirmation by biopsy of the involved target organs. However, symptoms of aGVHD are often non-specific and can be confused with other common etiologies (including infectious complications), biopsy results may be inconclusive, and waiting for the onset of clinical signs and biopsy results allows significant disease progression and thus eliminates the possibility of preemptive treatment.

Non-invasive approaches, such as the use of biomarkers to test for aGVHD, have been the subject of clinical research for a number of years, but previously suffered from a lack of clinical validation, established algorithmic value cutoffs and standardization between laboratories.

Viracor's three assays use an algorithm value based on ST2 and REG3α levels. The algorithm cutoffs have been validated to risk stratify severe aGVHD and NRM at distinct events post-allogeneic HCT:

• The aGVHD Pre-Symptomatic Algorithm, for use approximately 7 days post-transplant and before the patient shows onset of aGVHD symptoms. Based on this algorithm, high- and low-risk groups were assigned from analysis of samples collected 7 days post-HCT. ¹
• The aGVHD Symptomatic Onset Algorithm, for use post-transplant after the patient begins to display symptoms of aGVHD. For this use, two diagnostic thresholds assign patients to three risk groups corresponding to Ann Arbor (AA) risk groups 1, 2 or 3 for high, intermediate and low risk, respectively.¹
• The aGVHD Post-Treatment Algorithm, for use approximately 7 days or more after systemic treatment for aGVHD has been initiated. This algorithm can be applied to risk stratify steroid-resistant patients ≥1 week after the initiation of systemic treatment for GVHD. ² Results of the algorithm separated steroid-resistant patients into two risk groups (high or low) for NRM and overall survival.

Viracor delivers results of these testing algorithms to physicians within 24 hours of receiving the specimen, to help physicians get results faster when it matters most. For more information, visit www.viracor-eurofins.com/aGVHD.

About GVHD
Graft versus host disease (GVHD) is one of the major causes of NRM associated with allo-HCT. GVHD occurs in 30 – 50% of HLA-matched sibling transplants and 60 – 90% of matched unrelated donors.^3,4 GVHD often manifests in the skin, liver and/or gastrointestinal (GI) tract, and is caused by immune dysregulation that is initiated when allogeneic donor T cells recognize host tissues as foreign. GVHD may be either acute or chronic. Acute GVHD (aGVHD), which typically occurs in the first 3 months post-transplant, has an incidence of 19 – 66% and carries a poor prognosis if the disease is severe. The mean onset of aGVHD is around 1 month after the transplant occurs.

About Viracor Eurofins
With over 30 years of specialized expertise in infectious disease, immunology and allergy testing for immunocompromised and critical patients, Viracor Eurofins is committed to helping medical professionals, transplant teams, reference laboratories and biopharmaceutical companies get results faster, when it matters most. Viracor is passionate about delivering value to its clients by providing timely, actionable information, never losing sight of the connection between the testing it performs and the patients it ultimately serves.

Viracor is a 100 percent subsidiary of Eurofins Scientific (EUFI.PA), the global leader in bio-analytical testing, and one of the world leaders in genomic services. For more information, please visit www.viracor-eurofins.com.

About Eurofins - A global leader in bio-analysis
Eurofins Scientific through its subsidiaries (hereinafter sometimes "Eurofins" or "the Group") believes it is a scientific leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the emerging players in specialty clinical diagnostic testing in Europe and the USA. With over 38,000 staff in more than 400 laboratories across 44 countries, Eurofins offers a portfolio of over 150,000 analytical methods for evaluating the safety, identity, composition, authenticity, origin and purity of biological substances and products, as well as for innovative clinical diagnostic. The Group objective is to provide its customers with high-quality services, accurate results on time and expert advice by its highly qualified staff.

Eurofins is committed to pursuing its dynamic growth strategy by expanding both its technology portfolio and its geographic reach. Through R&D and acquisitions, the Group draws on the latest developments in the field of biotechnology and analytical chemistry to offer its clients unique analytical solutions and the most comprehensive range of testing methods.

As one of the most innovative and quality oriented international players in its industry, Eurofins is ideally positioned to support its clients' increasingly stringent quality and safety standards and the expanding demands of regulatory authorities around the world.

The shares of Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg ERF FP).

References

1 Hartwell MJ, Özbek U, Holler E. An early-biomarker algorithm predicts lethal graft-versus-host disease and survival. JCI Insight 2017, 2(3):e89798

2 Major-Monfried H, Renteria AS, Pawarode A., et al. MAGIC biomarkers predict long-term outcomes for steroid-resistant acute GVHD. Blood 2018, 131(25):2846-2855.

3(1) Ball LM, Egeler RM, EBMT Paediatric Working Party. Acute GvHD: pathogenesis and classification. Bone Marrow Transplant. 2008 Jun;41 Suppl 2:S58-64.

4(2) Deeg HJ, Henslee-Downey PJ. Management of acute graft-versus-host disease. Bone Marrow Transplant. 1990 Jul;6(1):1-8.

SOURCE Viracor Eurofins

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