Partner's Blog - December 2020

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The Corporate Affiliates Program provides an exciting opportunity for companies to support the work of the American Society of Transplantation (AST) and receive tangible benefits throughout the year. The following companies are members of the 2020 Corporate Affiliate Program (CAP):

What's News With Our Partners:

AlloSure® Heart is now covered by Medicare when used in conjunction with AlloMap® to assess the probability of allograft rejection in heart transplant recipients with clinical suspicion of rejection, and to inform clinical decision-making about the necessity of a heart biopsy in such patients at least 55 days post-transplant. AlloSure® Heart and AlloMap® comprise HeartCare®, CareDx’s innovative multi-modality solution for heart transplant patient surveillance. For more information, click here.

Pediatric Transplantation published “Donor‐derived cell‐free DNA (dd‐cfDNA) for detection of allograft rejection in pediatric kidney transplants.” Dr. Dechu Puliyanda et al. concluded that for pediatric kidney transplant patients, AlloSure was “highly predictive of histological rejection and superior to other indicators such as graft dysfunction or antibody positivity alone.” For the full publication, click here.
The CareDx AlloCare app is now live! This tool empowers transplant patients to take charge of their health. More information here.
More than 150 centers use RemoTraC – CareDx’s home-based blood draw service for transplant patients that includes AlloSure® and AlloMap®, along with a panel of routine tests. For more information contact remotrac@caredx.com.

CSL Behring has an immediate mission to investigate novel therapies to address chronic active antibody-mediated rejection and improve patient outcomes for kidney transplant recipients. Our ongoing pivotal Phase III clinical trial IMAGINE (Interleukin 6 blockade Modifying Antibody-mediated Graft Injury and eGFR decline) leverages clazakizumab, a genetically-engineered high affinity, humanized monoclonal antibody that acts as a possible inhibitor of the primary signaling molecule that causes a cascade of events leading to organ rejection. For over 100 years, CSL Behring has put patients first by delivering on its promise to discover and develop innovative life-changing therapies to address many of the world’s most serious and rare disorders. We are invested in extending that same commitment to the transplant community.

For any questions about our IMAGINE trial, or suggestions for additional clinical trial sites, please see this link to the IMAGINE trial at ClinicalTrials.gov and reach out to us directly at James.Lee2@cslbehring.com.

In accordance with the EU labeling, the EU Commission grants conditional approval for Idefirix® (imlifidase) in highly sensitized kidney transplant patients in the European Union

The formal approval by the European Commission was received on August 25, 2020, two months after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending conditional approval of Idefirix® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. Imlifidase is an investigational product in the US and is not yet approved for any indication.
Hansa Biopharma AB’s pivotal Highdes study, “Imlifidase desensitization in crossmatch-positive, highly-sensitized kidney transplant recipients: Results of an international phase 2 trial (Highdes) was published in Transplantation with an accompanying editorial by Dr. Carrie Schinstock. Jordan, et al (2020), concluded, “Imlifidase was well tolerated, converted positive crossmatches to negative, and enabled patients with a median cPRA of 99.83% to undergo kidney transplantation resulting in good kidney function and graft survival at 6 months.” For the full open access publication, please click here.
Dr. Bonnie Lonze (2020) published, “A Review of Imlifidase in Solid Organ Transplantation” in Expert Opinion in Biological Therapy and concluded, “Imlifidase is a first-in-class pharmaceutical agent that safely and efficiently cleaves IgG, and holds promise to be a game changer for sensitized patients in need of lifesaving organ transplants.” For the full publication, please click here.

2021 Call for Case Studies! Submit a case study to be presented during Immucor’s Virtual Antibody Workshop Series! Participate in driving continuing education to the HLA community by sharing interesting case studies. Send us any interesting or unique case studies you may have encountered. Have an antibody reacting “funny” or with unusual characteristics you would like us to present? Send it to us! All case studies will be anonymous and remember patient privacy regulations and to anonymize you submission. Contact your Immucor sales representative or marketinginformation@immucor.com to submit your case study today!
Immucor held its first Virtual HLA Scientific Symposium back in July 2020. It was held over a three day period and featured a wide variety of guest speakers including Dr. Emmanuel Zorn of Columbia University who spoke about Exploring New Horizons with LIFECODES® Non-HLA Antibody Kit and Dr. Peter Nickerson of the University of Manitoba who presented on Frontiers of Epitope Matching. If you missed any of the webinars you can view them on LEARN, Immucor’s Lab Education and Resource Network. Available on LEARN are many types of CE webinar recordings as well as other education courses. Once a course is completed on LEARN or a webinar is viewed, a CE certificate can be printed immediately from our LEARN website at https://immucor.knowledgeanywhere.com
Immucor is now a preferred partner of PIRCHE! Immucor is committed to uncovering new frontiers in epitope matching. Immucor’s integration tool provides automated data transfer to the PIRCHE matching modules with a simple click of a button! Utilizing the PIRCHE service REST, PIRCHE scores are transferred back to the tool. To learn more about using PIRCHE with Immucor’s MATCH IT! Antibody Software or MIA FORA NGS software or to arrange a demo contact your local Immucor representative or visit us on www.immucor.com.
Immucor’s next generation of LIFECODES® Non-HLA Antibody kit is now available! See beyond the limits of your existing workflow and expand your testing capabilities with Immucor’s Non-HLA Antibody kit. We are proud to sponsor the Non-HLA antigens in organ transplantation project coordinated by Dr. Henry G. Otten (The Netherlands) and Dr. Elaine F. Reed (USA) at the 18th International HLA & Immunogenetics Workshop May 2022 in Amsterdam, The Netherlands. Click here to see our new panel that now includes 28 new antigens for a total of 60! https://view.highspot.com/viewer/5fa955dd8117172260869a7f Join Immucor in a scientific partnership through LEAP, LIFECODES® Early Adopter Program. LEAP gives laboratories access to discounted LIFECODES® Non-HLA kits in exchange for data sharing. Collaborate with us to drive publications using the LIFECODES® Non-HLA Antibody kits!
Congratulations to Immucor’s Dr. Bryan Ray and Rhiannon Clouse! Bryan and Rhiannon submitted a ASHI Poster Abstract at this year’s 2020 Virtual Global Annual Meeting and were awarded the People's Choice Award for their poster entitled: COMPARING MFI VALUES BETWEEN LUMINEX 200 AND FLEXMAP 3D INSTRUMENTS. The aim of the study is to understand the MFI differences between the two systems in the standard mode in the absence of any MFI divisor and how this difference may be impacted by the particular assay being run. The primary finding is that the MFI ratio of FM3D/ LX200 is assay dependent. Click here to view the award winning abstract!

Mallinckrodt released the following new releases:

Mallinckrodt Announces Data at Kidney Week 2020 Reimagined that Showed A Potential for Reduced Need for Renal Replacement (RRT) Therapy for Patients with Hepatorenal Syndrome Type 1 (HRS-1) Treated with Terlipressin – Oct 29 Read More
Real-World Data of Terlipressin in Hospitalized Patients in U.K. with Hepatorenal Syndrome Type 1 (HRS-1) Published in Alimentary Pharmacology and Therapeutics – June 11 Read More

New data will be presented at the ASTS Winter Symposium 2021, including our lunch symposium titled "Breakthrough DNA Applications in Multi-Organ Transplant & Kidney Health" and "Coffee & Conversations on Cancer." RSVP to Natera's multiple events with our esteemed list of speakers at natera.com/organ-health/asts-2021
Introducing Natera's COVID-19 Community of Practice: We understand that the transplant and nephrology communities are experiencing the complex effects of the Severe Acute Respiratory Syndrome 2 virus (SARS-CoV-2) on patient care. Natera has developed a bimonthly newsletter to share our important findings as we navigate this ever-evolving pandemic. We extend our call for stories, research and experiences to our transplant and nephrology partners so we can continue to learn together and improve patient lives during these uncertain times. Explore at: natera.com/community-practice-covid-updates
Natera is sponsoring the KDIGO Webinar Series on Genetics in CKD. Episode 4 will cover "Controversies, Barriers, and Practical Challenges to Genetic Testing (CME credit)." This will take place on Thurs, Jan 21. Email renasight@natera.com for registration information.
Experience the continuity, connection and convenience of staying close with your transplant patients, particularly those concerned about in-office visits due to immunosuppression and COVID-19. The ProReach Program uses Natera's nationwide mobile phlebotomy network to order the Prospera test and routine blood draws for kidney transplant recipients. Check out natera.com/proreach to learn more

Recent Publications: In a new paper on “Analysis of RNA Transcripts by the Molecular Microscope Diagnostic System (MMDx) Can Direct Management after Indication Kidney Transplant Biopsy,” Drs. Chris Lawrence, the Director of Medical Affairs for Transplant Diagnostics at Thermo Fisher Scientific, Sarah Fluck, et al, explore 2 case studies where clinical decision making was impacted by the use of the Molecular Microscope® Diagnostic System (MMDx). In both cases MMDx offered certainty when traditional pathology did not and showed its potential as a tool to better guide treatment. Read More

Veloxis Pharmaceuticals, Inc. collaborated with renal transplant providers to develop a series of webinars on telemedicine. To view these webinars click the title of interest:

What Awaits Your Patients After Kidney Transplant? Find out here.

Check out all of our CAP partners: