Following the launch in April 2020 of Labs@Home in response to the COVID-19 pandemic began impacting transplant patient care and the world, Transplant Genomics, Inc. announced today the successful growth of TruGraf® driven by adoption of Labs@Home. TruGraf, the only blood test approved by CMS for surveillance to rule out “silent” subclinical acute rejection (subAR) in kidney transplant recipients with stable graft function, has been recognized as crucial to reducing risk in outpatient management after a kidney transplant during COVID-19 in a recently published article from Yale University.
During the COVID-19 pandemic, typical protocols for management of kidney transplant recipients have been difficult to maintain as immunocompromised patients have been urged to stay at home and avoid visiting clinics for routine blood draws or surveillance biopsies. At the same time, clinicians understand that lack of adequate surveillance poses an even greater risk to their patients’ health. Published data informs us that while ~25% of patients undergoing a surveillance biopsy will show signs of rejection roughly three times as many, i.e. ~75%, will have a healthy kidney, which means that with the benefit of hindsight, the invasive tissue biopsy was ultimately unnecessary. With the presence of COVID-19, these risks are further inflated, creating significant unnecessary risks for otherwise healthy patients, making them the highest risk-benefit category of transplant recipients. For these patients with stable graft function, TruGraf, a peripheral blood gene expression test, provides a liquid biopsy alternative that can reliably rule out whether there is “silent” subclinical acute rejection. Labs@Home enables the necessary blood samples to be collected at home, enabling patients to avoid taking on the added risk of a clinic visit and minimizing the patient load at hospitals where resources are devoted to COVID-19 care.
In one recently published article from Yale School of Medicine, Drs. Shana E. Gleeson, Richard N. Formica, and Ethan P. Marin highlighted this problem accurately, reminding physicians and patients alike the critical benefit and differences in context-of-use between TruGraf and donor-derived cell-free DNA (dd-cfDNA) that “Performance of for-cause biopsies presents another exposure risk, and during this pandemic, the risk-benefit ratio must now incorporate potential exposure to SARS-CoV-2 in the health care facility. As an alternative, practitioners may consider using noninvasive measures of transplant rejection, such as donor-derived cell-free DNA (which may be used in place of for-cause biopsy) or peripheral blood gene expression tests (which may substitute for protocol biopsies).”
Labs@Home is an in-home blood draw service to aid in specimen collection for routine labs and specialty labs directly from a patient’s home. Through our partners at Viracor, clinicians can order and customize remote sample collection to test for a number of infectious diseases, including COVID-19. As part of Eurofins, TGI is actively working to further improve the convenience and quality of service offered to transplant patients, with more announcements expected soon.