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Event Summary

Dr. James Ferrara presented information on Viracor’s aGVHD Algorithm testing for Pre-Symptomatic, Symptom Onset, and Post-Treatment Hematopoietic Cell Transplant patients (HCT) at high risk for non-relapse mortality and acute graft-versus-host disease. Dr. Ferrara discussed the biology of the biomarkers utilized in the aGVHD Algorithm testing (REG-3α and ST2), explaining how they act as a “liquid biopsy” of the GI tract.

Dr. Ferrara explored three different clinical scenarios where utilization of the aGVHD Algorithm Tests could predict non-relapse mortality and aGVHD. While reviewing example reports for each of the clinical scenarios, Dr. Ferrara recommended the desired approach for treatment.

Dr. James Ferrara, Ichan School of Medicine Mount Sinai

About Viracor's aGVHD Biomarker Testing

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.

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.

POST-TREATMENT

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

Read Viracor's Abstract Poster Findings, Presented at 2019 TCT Meetings

Send your testing to a lab that's leading the industry in testing research and development. Learn how Viracor and our partners are taking clinical diagnostic testing to the next level.

Stability of CMV CD4 and CD8 T Cell Responses in Seropositive Donors and Evaluation of Immunosuppressed Patients

Recent studies have shown that measuring a patient’s CMV specific Tcell mediated immunity may provide valuable information to physicians for monitoring CMV infection/disease in transplant patients and may aid in determining which patients need antiviral therapy. Questions have been raised about how variable these responses are. The goal of this study is to evaluate the stability of the CMV Tcell response in seropositive donors overtime.

Acute Graft-Versus-Host Disease (aGVHD, Non-Relapse Mortality) Risk Prediction Assay: Validation and Initial Reference Lab Experience

aGVHD affects 40% to 60% of hematopoietic cellular transplant (HCT) patients, targeting the skin, liver, and gastrointestinal tract with a median onset approximately 1 month after transplant. In 2017, an interpretive algorithm based on serum ST2 and REG3α levels was clinically validated (JCI Insight 2017;2(3):e89798).

Detection of CMV Antiviral Resistance Mutations to Letermovir in Patients Using a Validated Clinical Sequencing Assay

Antiviral resistance to human CMV is an important complication for immunocompromised patients on prolonged antiviral regimens, and CMV remains the most clinically significant infection following allogeneic hematopoietic-cell transplantation (HCT). Letermovir targets subunit 2 of the viral terminase complex (UL56) and is approved for CMV prophylaxis in adult HCT recipients. Resistance to letermovir is conferred by point mutations in the UL56 gene, and with the potential clinical need for antiviral resistance testing, we have developed a UL56 sequencing assay covering 26 identified resistance mutations.

About Dr. James Ferrara

Ward-Coleman Chair in Cancer Medicine
Professor of Pediatrics & Medicine, Icahn School of Medicine at 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.

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With over 30 years of specialized expertise in infectious disease, immunology and allergy testing for immunocompromised and critical patients, Viracor is committed to helping medical professionals, transplant teams, reference labs and biopharmaceutical companies get results faster, when it matters most.

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This promotional activity is provided by Viracor and is not certified for continuing education credit. The content of this Product Theater and opinions expressed by presenters are those of the sponsor or presenters and not of the TCT Meetings, ASBMT or CIBMTR.

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