Partner's Blog - September 2022

Thanks for visiting the September 2022 Partner's Blog!

Thank you for visiting the September 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:

New COVID-19 prevention educational resources for transplant patients are available

As you know, millions of people in the US are immunocompromised (IC). These individuals are at high risk for COVID-19 and increased odds for severe outcomes despite vaccination status because they may not be able to develop an adequate immune response. In fact, the CDC published a study, which determined IC adults accounted for a disproportionately high percentage (12.2%) of patients hospitalized with COVID-19 in comparison to roughly 2.7% of the US adult population.¹

IC patients facing this reality often experience increased anxiety when trying to navigate new and evolving complexities presented by the pandemic, but they are not alone. With support from patient advocacy organizations, healthcare experts, patients and caregivers, we’ve created Up The Antibodies: an educational campaign that elevates the diverse voices of the IC community as they carefully re-emerge from the pandemic. Up The Antibodies provides patients with resources about how to reduce their risk of COVID-19 and the steps they can take to receive additional layers of protection to prevent COVID-19.

To view patient-friendly resources and read about how members of the IC community manage their disease amidst COVID-19, visit UpTheAntibodies.com or follow along with the community on Facebook, Instagram, and Twitter (@UpTheAntibodies).

References

1. Singson JRc., Kirley PD, Pham H, et al. Factors associated with severe outcomes among immunocompromised adults hospitalized for covid-19 - covid-net, 10 states, March 2020–February 2022. Centers for Disease Control and Prevention. https://www.cdc.gov/mmwr/volumes/71/wr/mm7127a3.htm. Published July 7, 2022. Accessed August 2, 2022.

CareDx announced a new peer-reviewed publication showing that AlloMap® resulted in less pain and fewer adverse events compared to heart biopsy. In an independent, prospective study performed at Baylor University Medical Center, forty-three heart transplant patients undergoing surveillance with a protocol that included both routine cardiac biopsy and AlloMap testing, reported significantly less pain and experienced fewer adverse events (no bleeding or swelling) with AlloMap than with biopsy. To see the full story, read the press release here.

The Transplant Company™ recently announced that it has served its 100,000th transplant patient, representing one out of ten patients transplanted in the U.S. This milestone demonstrates strong clinical adoption of molecular surveillance for transplant patients and showcases AlloMap® and AlloSure® as leading tools which are becoming firmly embedded in post-transplant patient care. To learn more about CareDx surveillance solutions, contact us today

AlloHome™ a pan-organ patient monitoring solution, is now available to clinicians across the US. Through a fully integrated system, biometric results collected with the AlloHome devices will seamlessly flow into the AlloCare app without manual entry. Readings of real-time data are transmitted to trained CareDx transplant professionals who can escalate potential concerns to the patient’s doctor in a timely manner. Visit our website to get started with AlloHome.

CareDx recently updated the AlloCare® mobile health app to expand features to medication adherence and patient-provider communication capabilities resulting from the successful integration of MedActionPlan®, an acquisition made last year. Download the AlloCare app today to see how it helps patients navigate the pre-transplant referral and waitlist process, and post-transplant helps to track their personal health metrics and test results, manage their complex medication regimens, and connect with other users who have had a transplant

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

New kidney transplant assessment publication: Combining donor fraction and estimated amount of dd-cfDNA can significantly improve performance, compared to either variable alone. Led by Dr. Philip Halloran, the publication highlights how the Prospera^TM dd-cfDNA test with a dual threshold can be a more accurate approach to identify rejection, than tests with donor fraction alone. Click here to read the latest study and hear Dr. Halloran's talk
Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference advises practitioners to "Think Genetic." In May 2022, KDIGO published an executive conclusions paper stating, "Given the important contribution of genetic variants to CKD, practitioners with CKD patients are advised to 'think genetic.'" Renasight^TM provides a comprehensive approach to incorporating genetic testing into daily practice. Conveniently, Renasight^TM comes with unparalleled access to board-certified genetic counselors and patient and provider support services. Get started today
RenasightTM is a genetic test that uses next-generation sequencing (NGS) and other methodologies to identify germline genetic factors causing or contributing to kidney disease from a patient’s blood or buccal sample. The test identifies certain autosomal dominant, autosomal recessive and X-linked disorders, and the APOL1 risk allele. Providers can use RenasightTM to identify a genetic predisposition, clarify a clinical diagnosis, determine the etiology of an unknown kidney disease, and to help inform medical management. Additionally, genetic counseling and familial testing can be offered based on the test result. Learn more about the Renasight test

Quest Advanced Specialized Transplant Services: Meeting the testing needs of the transplant center

The number of transplantation operations, both for solid organs and stem cells, has increased steadily for over a decade. Every transplantation requires comprehensive testing of both donor and recipient, and recipients require regular and frequent testing for infectious disease, involving an average of 500 separate tests over the course of a patient’s life. This testing regimen helps ensure that the patient remains free of infection despite lifelong immunosuppression.

To provide the best transplantation outcome, the health care professional needs a comprehensive test menu, a simple and powerful ordering process, an extremely rapid turnaround time, authoritative test results, and access to experts to help interpret results and expedite clinical care decision-making.

Quest Advanced Specialized Transplant Services meets these critical needs, providing the health care professional an end-to-end testing process that is streamlined, intuitive, flexible, and comprehensive, with next-day results and seamless integration with any existing medical record system. For testing throughout the transplant journey, Quest offers service that is unmatched in the testing environment.

The right tests and the right codes
Quest has designed its Advanced Specialized Transplant Services with the transplant professional and patient in mind. Test codes trigger processing and handling protocols, as well as access to a dedicated customer support team, that are specific for pre-transplant testing and post-transplant infectious diseases testing. Extensive new test code options provide the health care professional the specificity they need when ordering serum, whole blood, sputum, or other fluid samples—each sample type comes with its own test code.

Post-transplant infectious disease testing codes direct samples for immediate processing and reporting, so that results are provided as soon as they are completed, even when other tests are ordered at the same time.

Patient Services Centers improve compliance
Patients can provide specimens in the physician’s office, or at any one of Quest’s 2,200 Patient Services Centers (PSCs) across the country. Compliance improves, especially over the long haul, when patients can have their samples drawn conveniently and reliably, on their schedule and where they are geographically located regardless of the physician’s location. PSCs are fully stocked with test kits for each of the tests within the Advanced Specialized Transplant Services, and test requisitions are fully integrated with the ordering professional’s electronic medical records system.

Free and fast shipping
Quest provides a complete kit for taking and shipping the sample, including phlebotomy supplies, video instructions, packing and shipping materials, and test-specific labels, ensuring the sample will be shipped and the test will be processed without delay.

Once it is ready to go, Quest provides complimentary shipping for all specimens, with no minimum order. Every sample is shipped FedEx for next-day delivery for the most rapid delivery to the Quest lab.

Results: Highly accurate, and very fast
All post-transplant infection specimens are processed upon receipt, allowing Quest to deliver results within 8 to 12 hours after receipt, matching or exceeding what is offered by other labs. Donor test results are provided within 24 hours of sample receipt.

All post-transplant tests are performed at Quest Centers of Excellence. Polymerase chain reaction provides high sensitivity and specificity for the full range of potential pathogens. Donor testing is performed at our FDA-registered lab in Chantilly, VA. Full data is provided in a comprehensive and easy-to-understand format, including historical results and graphical interpretation. Quest’s Infectious Disease team is available to help interpret results when needed, and Quest’s Dedicated Customer Operation Team is on call to proactively address delays or redraws and troubleshoot any issues that arise.

Results can be made available in any electronic medical records system, or by paper copy or fax, if preferred.

Flexible billing options
Quest offers complete billing flexibility, including billing the client or a third-party payer. That flexibility offers the health system the choice that works best for their practice.

Quest Advanced Specialized Transplant Services provides the transplant center and health care professionals with a complete solution for fast, reliable, and tailored post-transplant testing, providing the accurate, rapid results that are needed throughout the transplant journey.

This July at the 2022 Transplant Games of America in San Diego, Sanofi had the privilege of bringing together recipients and donors to share their experiences and connect with one another.

Sanofi volunteers were joined by members of the Kidney Transplant Connectors (KTC) program and representatives from the Living Donation Storytelling Project. Together we helped support the transplant community and brought organ donation awareness to the city of San Diego.

Sanofi recognized AST’s patient advocacy work and was a proud sponsor of the Fight for your Right - Transplant Advocacy 101 AST workshop at the Transplant Games. This workshop provided an overview of legislative issues impacting transplantation and training on how to be an effective advocate.

The U.S. Centers for Medicare and Medicaid Services (CMS) has approved Takeda’s New Technology Add-on Payment (NTAP) application for hospitals that administer one of Takeda’s medicines in the inpatient setting to fee-for-service Medicare patients. Payments will become effective on October 1, 2022. By providing additional reimbursement above standard DRG payments for these patients, NTAP will enhance access to needed therapy and help the nation’s hospitals maintain sustainable care.
On September 9, Takeda received approval from the FDA for its Prior Approval Supplement (PAS) application for a treatment of post-transplant CMV. This approval allows the drug to be consumed as a whole, and dispersed or crushed tablets by mouth or via a nasogastric (NG) and orogastric (OG) tubes for patients requiring these important alternatives to oral drug administration.
Takeda has launched a series of short educational Pop-Up Videos on post-transplant Cytomegalovirus (CMV) and related issues for transplant candidates and recipients. The first installment, “Fast Facts on Post-Transplant CMV,” is now available on Takeda’s YouTube, Twitter and LinkedIn channels.
During National Minority Donor Awareness Month in August, Takeda stood with the National Multicultural Action Group (NMAG) and Donate Life to build awareness of the need for organ donations within minority communities. Takeda is committed to addressing inequities in access to transplant care. See Takeda’s outreach on LinkedIn and Twitter.

Verici Dx presented the data on its prospective, blinded, multicenter study involving fourteen international transplant centers. This study is designed to validate Tutivia™ in correlation to acute rejection in kidney biopsy across the histological continuum. Inclusion criteria represents a clinically inclusive and representative patient population, including extended criteria donors (high KDPI), DCD donors, patients with pre-formed DSA to Class I and Class II HLA, and Black recipients (21%). The poster was presented and referenced during the closing session of the “What’s new / What’s hot” roundup. The full poster is available at https://vericidx.com/clinical

Verici Dx and AST have partnered to create the AST Research Network/Verici Dx Basic Science Fellowship Research Grant honoring the late Dr. Barbara T. Murphy and her extraordinary contributions to the field of transplantation. The value of the initial grant is $50,000. We are excited to congratulate the first awardee, Dr. Cindy Avalos, PhD at the University of Pittsburgh, for her work looking at small extracellular vesicles as regulators of dendritic cell maturation and hepatic ischemia-reperfusion injury.

Verici Dx, Renalytix, AST, and ASN, have partnered to create the Dr. Barbara T. Murphy endowed lectureship starting at ASN Kidney Week 2022. This lectureship commemorates Dr. Murphy and her legacy of transplant immunology by recognizing advances in kidney transplantation. Each lecture will focus on kidney risk pre-transplant and transplant care.

Dr. Oriol Bestard will be doing an oral presentation; “Clinical performance validation of Tutivia Biomarker” at the ASN kidney week national conference, on Saturday, November 5^thduring the session titled: Transplantation: Clinical Outcomes and Biomarkers. We look forward to seeing you there! Please stop by our booth #1306 to learn more about Verici Dx.

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.

Check out all of our CAP partners: