Viracor Eurofins recently 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.
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 informationvisit www.viracor-eurofins.com.