Partner's Blog - December 2022

Thanks for visiting the December 2022 Partner's Blog!

Thank you for visiting the December 2022 Partner's Blog! I hope that you find the featured information helpful.

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 2022 Corporate Affiliate Program (CAP).

For additional partner information, check out AST Partner Connect.

Richard Formica
AST Development Chair

What's News With Our Partners:

Three leaders in transplant testing. One name. Together, Eurofins Donor & Product Testing, Eurofins Transplant Genomics, and Eurofins Viracor are Eurofins Transplant Diagnostics.

Eurofins Transplant Genomics has served its 10,000th transplant patient. This milestone highlights the importance of blood-based biomarkers in clinical care for giving the earliest and most accurate insight into the patient’s allograft health—empowering clinicians to provide the best possible long-term outcomes.

Eurofins Transplant Genomics (TGI) launched TruGraf® Liver. TruGraf Liver is the first and only non-invasive diagnostic test that provides guidance for the optimization of immunosuppression therapy in liver transplant recipients. TruGraf Liver is the first diagnostic tool that leverages gene expression data—powered by TGI’s proprietary technology and machine learning—to confirm immune quiescence and rule out organ rejection for liver transplant recipients. Learn about a new way to optimize immunosuppression in liver transplant recipients here.

Eurofins Viracor launched EBV inSIGHT™ T Cell Immunity Testing, a functional T Cell test to measure CD4 and CD8 Epstein-Barr virus-specific T cell immune response. The test joins the innovative inSIGHT diagnostic portfolio of virus-specific cell mediated immunity tests offered by Viracor. EBV is a common risk factor for post-transplant lymphoproliferative disorders (PTLD) in patients following solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT). PTLD can arise due to immunosuppression and the loss of T cells that typically control EBV reactivation. Learn more about EBV inSIGHT™ T Cell Immunity Testing here.

Mallinckrodt Pharmaceuticals is pleased to announce US FDA approval for
TERLIVAZ^® (terlipressin) for injection. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function.¹See limitation of use below.

Terlipressin is recommended as the preferred treatment for HRS according to the American Association for the Study of Liver Diseases guidance.² It is one of the most studied pharmacological agents in HRS with more than 70 published manuscripts and presented abstracts on clinical data to date.³

To learn more about TERLIVAZ, visit our website.

INDICATION AND LIMITATION OF USE

TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with

rapid reduction in kidney function.

Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE

TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO₂) before initiating TERLIVAZ.
Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO₂ <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO₂ decreases below 90%.

Contraindications

TERLIVAZ is contraindicated:

In patients experiencing hypoxia or worsening respiratory symptoms.
In patients with ongoing coronary, peripheral, or mesenteric ischemia.

Warnings and Precautions

Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients. Monitor patients for changes in respiratory status using continuous pulse oximetry and regular clinical assessments. Discontinue TERLIVAZ in patients experiencing hypoxia or increased respiratory symptoms.

Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and through judicious use of diuretics. Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves. Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure.

Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed. For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.
Ischemic Events: TERLIVAZ may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Avoid use of TERLIVAZ in patients with a history of severe cardiovascular conditions or cerebrovascular or ischemic disease. Discontinue TERLIVAZ in patients who experience signs or symptoms suggestive of ischemic adverse reactions.
Embryo-Fetal Toxicity: TERLIVAZ may cause fetal harm when administered to a pregnant woman. If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus.

Adverse Reactions

The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.

Please see full Prescribing Information, including Boxed Warning, by clicking here.

References

1. TERAZ. Prescribing information. Mallinckrodt Pharmaceuticals; 2022.
2. Biggins SW, Angeli P, Garcia-Tsao G, et al. Diagnosis, evaluation, and management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome: 2021 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021;74(2):1014-1048.
3. Data on File – Ref-05488. Mallinckrodt Pharmaceuticals.

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.
© 2022 Mallinckrodt. US-2200830 09/2022

Did you know that standardizing the evaluation process for all living kidney donor (LKD) candidates across centers may increase living donor kidney transplants and reduce racial disparities?^1,2

Sanofi has developed an educational presentation that focuses on improving living kidney donor evaluation, education, and risk assessment that will be delivered by experts on the subject.

Program objectives include:

Discuss the effect of racial disparities in the living donor evaluation process
Review how to educate donors about risk of ESRD
Highlight the role of genetic testing in the LKD evaluation
Explore post-donation follow-up techniques and communication tools to better support donors

Click here for more information on Sanofi’s partnership with the transplant community

References: 1. Kumar K, et al. Clin Transplant. 2018;32(7):e13291. doi: 10.1111/ctr.13291. 2. Waterman AD, et al. Clin J Am Soc Nephrol. 2013;8(6):995-1002.

November marked one year on the U.S. market for one of Takeda’s medicines that supports post-transplant care with a patient-first approach. In that time, Takeda has reached over 75% of transplant centers in the U.S. with this medicine for post-transplant cytomegalovirus (CMV)[i], helping patients and their healthcare providers look ahead to life after transplant. You can learn more about the history of Takeda and Transplant here: “Takeda & Transplant graphic”
Takeda and its partner, PatientsLikeMe (PLM), a digital platform for patients, are actively recruiting for a three-phase Post-Transplant Experience study which will utilize insights from PLM’s unique patient dataset and support Takeda’s research goals to better engage Solid Organ Transplant and Hematopoeitic Stem Cell Transplant patients. The study seeks to gain insights to better understand the transplant patient journey, particularly if they’ve experienced cytomegalovirus (CMV) infection. Learn more about participating in the study here and about Takeda’s partnership with PLM here.

Takeda.com – Takeda Delivers Strong FY2022 H1 Results and Raises Full Year Forecast (Uploaded 10/2022)

Verici Dx, Renalytix, AST, and ASN, partnered to create the Dr. Barbara T. Murphy, MB, BAO, BCh, endowed lectureship. This lectureship commemorated Dr. Murphy and her legacy of transplant immunology by recognizing advances in kidney transplantation. Dr. Rosalyn Mannon MD, FASN, FAST, a colleague and friend of Dr. Murphy presented: “ Improving Kidney Graft Long-term Outcomes: Lessons Learned and New Perspectives. The meeting content is available in the Kidney Week platform through December 21. In mid-January, content will move to the ASN eLearning.

Dr. Oriol Bestard, MD, PhD. presented; “Clinical performance validation of Tutivia Biomarker” at the ASN kidney week national conference, on Saturday, November 5th during the session titled: Transplantation: Clinical Outcomes and Biomarkers.

Tutivia™ is a blood-based transcriptomic signature that utilizes mRNA expression values of select genes, with a proprietary algorithm, to correlate an acute rejection risk score with rejection phenotype, based upon kidney biopsy histopathology, using BANFF 2019 criteria.

Verici Dx is a developer of a complementary suite of leading-edge technology, forming a kidney transplant platform, to assist clinicians ability to improve patient outcomes from pre-transpant throughout the post-transplant period. The underlying technology is based upon artificial intellegence assisted transcriptomic analysis. We are committed to partnering with transplant clinicians, to impactfully change the quality-of-life for kidney transplant patients, and the longevity of kidney grafts, globally.

To learn more about VericiDx, our commitment to the transplant community, and out kidney transplant technology platform, click on the link here to go to our website. https://vericidx.com

Check out all of our CAP partners: