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How are the aGVHD algorithms different? What are the advantages?

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, and validated in conjunction with 17 hematopoietic cell transplantation (HCT) centers to help predict the risk of non-relapse mortality (NRM) and aGVHD in HCT patients. 1,2

The new algorithms have clinically validated cutoffs to help healthcare providers definitively identify patients at risk, delivering actionable data that could improve outcomes.

Advantages of aGVHD Algorithms

  • Predicts high risk NRM and severe aGVHD
  • Guides decisions to begin preemptive intervention
  • Minimizes the risk for relapse & infectious complications; potentially avoids the need for high levels of immunosuppression
  • Provides a faster, cost effective & less invasive testing option than biopsy
  • Delivers results in less than 24 hours from specimen receipt
View aGVHD Test Menu
Read aGVHD White Paper
About Dr. James Ferrara
Read Press Release
. . . the MAGIC algorithm represents an important advance toward precision medicine for HCT patients.

Hartwell MJ, et al. JCI Insight. 2017;2(3):e89798.

The First aGVHD Algorithms for Evaluating High Risk HCT Patients

Test Name Clinical Situation for Use Test Results / Reporting
aGVHD Pre-Symptomatic Algorithm

Patient is not yet showing symptoms for aGVHD post transplant

Report includes:

  • REG3α value
  • ST2 value
  • Algorithm value

Interpretation of results, based on clinically validated cutoffs, is provided for each application. Interpretation consists of risk for severe acute GVHD and non-relapse mortality. 

aGVHD Symptomatic Onset Algorithm

Patient begins displaying symptoms for aGVHD post transplant

aGVHD Post-Treatment Algorithm

Patient has been given treatment post aGVHD post transplant

Get Greater Insight Into aGVHD

Predict Risk

PRE-SYMPTOMATIC

Using the pre-symptomatic algorithm with a blood sample taken approximately 7 days after transplant, physicians can identify a patient at high risk for severe aGVHD and NRM, when the patient is not actively displaying symptoms, and can potentially adjust therapy to mitigate identified risks.

“…the use of the MAGIC algorithm could facilitate preemptive intervention for GVHD prior to the onset of clinical disease in a substantial number of patients.” 1

Confirm aGVHD

SYMPTOMATIC ONSET

With the symptomatic onset algorithm, results predict the pathology of some of the most severe forms of aGVHD — for example, presentation in the gastrointestinal tract — before disease progression becomes serious.

“We now appreciate that both ST2 and REG3α are closely associated with GI GVHD and we speculate further that the levels of these biomarkers’ concentrations both on day 7 and at the onset of overall symptoms reflect GI pathology that is not yet clinically apparent.” 1

Evaluate Steroid Resistant Patients

POST-TREATMENT

The post-treatment algorithm allows healthcare providers to identify high-risk patients for treatment resistance with increased odds of NRM.


"The algorithm analysis identified an unexpectedly large proportion (48%-72%) of the early treatment–resistant patients as low probability and who experienced strikingly less NRM than the high probability group in all 3 cohorts." 2

HR [high risk] patients were 3 times more likely to die from GVHD than LR [low risk] patients when all 1,287 patients were considered (HR 19% vs. LR 6%, P < 0.001) and the difference was statistically significant within each set.

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

Validation of an interpretive algorithm based on serum ST2 and REG3α levels accurately predicts risks for allo-HCT patients when testing is performed at 7 days post-transplant, at the onset of aGVHD symptoms, and ≥ one week after the initiation of systemic therapy.

Steve Kleiboeker, PhD, Vice President Research & Development

...accurate prediction of durable responses and long-term outcomes is key to escalation and de-escalation of immunosuppressive therapy.

Major-Monfried H, Renteria AS, Pwarode A, et al. MAGIC biomarkers predict long-term outcomes for steroid-resistant acute GVHD. Blood. 2018 Jun 21;131(25):2846-2856. [PubMed]

White Paper:

Diagnostic methods to predict outcomes for acute graft versus host disease in allogeneic hematopoietic cell transplant recipients

By Steve Kleiboeker, PhD, Vice President of Research and Development

Application of clinically validated cutoffs has allowed stratification of patients into risk categories at approximately 7 days post-transplant, at the onset of clinical signs, and following 1 week of treatment. Knowledge of a patient’s individual risk will allow adjustments to therapy with a goal of improved outcomes.

About Dr. James Ferrara, Mount Sinai

Ward-Coleman Chair in Cancer Medicine
Professor of Pediatrics & Medicine, Ichan School of Medicine Mount Sinai

Dr. James Ferrara is a physician-scientist whose clinical and research career has focused on the immunology of bone marrow transplantation (BMT), particularly its major complication graft versus host disease (GVHD). Using trailblazing proteomic techniques, his team has identified and validated unexpected biomarkers for skin, gut and steroid-resistant GVHD. He has created exceptionally large and informative biorepositories and then mined them to meld these biomarkers into the first algorithm that predicts response to treatment and that can guide GVHD therapy. Dr. Ferrara’s pioneering mechanistic studies have illuminated unexpected interactions between the innate and adaptive immune systems and have led to both conceptual breakthroughs and the discovery of novel therapeutic targets. A superb clinician and world-class clinical investigator, his decades-long focus on GVHD has significant potential impact in making BMT safer and more effective for all patients. 

Dr. Ferrara graduated Cum laude from Georgetown Medical School and then completed his pediatric residency and fellowship at Boston’s Children’s and the Dana-Farber Cancer Institute. After 19 years he went to the University of Michigan to direct the combined adult and pediatric BMT program. The Icahn School of Medicine at Mount Sinai recruited Dr. Ferrara in 2014 to become the Ward-Coleman professor of Cancer medicine and to direct the Center for Translational Research in Hematologic Malignancies.

Dr. James Ferrara MAGIC Algorithm

Dr. Ferrara Presents the Biology of the aGVHD Algorithms at ASH 2018:

Reining in Graft Versus Host Disease (GVHD) After Allogeneic Hematopoietic Cell Transplantation

The 60th American Society of Hematology (ASH) Annual Meeting and Exposition
December 1 – 4, 2018.  San Diego, CA

ASH is one of the leading hematology events of the year. Presenting during the Educational Program, Dr. Ferrara will speak about the biology of GVHD in the intestinal tract which is the most difficult organ to treat. The ability of serum biomarkers that predict long term GVHD outcomes, which relate primarily to the intestinal tract, will also be discussed, including new biologic insights offered by the biomarkers.

Testing Solutions for Acute GVHD

Test Name - Specimen Type Test Code CPT Code(s) Turnaround Time
NEW aGVHD Pre-Symptomatic Algorithm - serum 403571 83006, 83520

Same day (within 24 hours from receipt of specimen), Monday through Friday.

NEW aGVHD Symptomatic Onset Algorithm - serum 403572 83006, 83520
NEW aGVHD Post-Treatment Algorithm - serum 403573 83006, 83520
Elafin - serum 30140 83520

3 business days from receipt of specimen

Elafin - plasma 30141 83520
Hepatocyte growth factor (HGF) - serum 30142 83520
Hepatocyte growth factor (HGF) - plasma 30143 83520
Interleukin-8 (IL-8) - serum 1219 83520 3-5 business days from receipt of specimen
Interleukin-8 (IL-8) - plasma 1229 83520
Soluble IL-2 Receptor (sIL-2R) - serum 30057 84238 7 business days from receipt of specimen
Soluble TNF receptor 1 (sTNF RI) - serum 30144 84238 3 business days from receipt of specimen
Soluble TNF receptor 1 (sTNF RI) - plasma 30145 84238

New to Viracor?

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We would be honored to be your diagnostic testing partner. For more information and to set up an account, please click on the button below.

References

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

2 Major-Monfried H, Renteria AS, Pwarode A, et al. MAGIC biomarkers predict long-term outcomes for steroid-resistant acute GVHD. Blood. 2018 Jun 21;131(25):2846-2856.

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