MMDX Resources

Coverage of Molecular Testing for Post-Transplant Solid Organ Assessment Announced by Palmetto GBA

The Molecular Microscope® Diagnostic System can help distinguish rejection or injury at the molecular level.

We’re excited to announce that this important post-transplant monitoring technology now has an avenue for coverage with a future effective LCD.

Palmetto GBA, a Medicare Administrative Contractor (MAC) announced a new Medicare local coverage determination (LCD) on “Molecular Testing for Solid Organ Allograft Rejection” (L38568) to support the assessment of a transplanted organ for rejection status.

Under the future effective LCD, the Molecular Microscope Diagnostic System (MMDx®) has a pathway to coverage for post-transplant monitoring in heart and kidney.

In recent years, organ transplant procedures have been steadily rising in the United States, with kidney transplants across all age groups increasing 24% from 2014 to 2018. During the same period, heart transplants rates increased by 28%.

The Medicare LCD is available on the Centers for Medicare and Medicaid Services (CMS) site and will become effective on June 6, 2021.

Graft Dysfunction Remain a Major Obstacle to Patient Health and Quality of Life

While transplantation is a life-changing therapy for many patients with end-stage kidney or cardiac disease, long-term graft survival continues to be a challenge.

According to the Organ Procurement and Transplantation Network (OPTN), failure of a transplanted kidney is reported in 21% of deceased-donor kidney transplant recipients and 14% of living-donor kidney recipients at five years after transplant. Among heart transplant recipients, 25% will experience rejection five years after the procedure.

For these patients, more effective tools are needed to detect the presence and diagnose the causes of allograft dysfunction. To determine the best course of treatment and immunosuppressive regimen, clinical teams need better tools to determine if dysfunction is due to antibody-mediated rejection (ABMR), T-cell-mediated rejection (TCMR), or a combination of both.

Errors in assessment can lead to missed opportunities for therapies or unnecessary treatment with immunosuppressive drugs.

MMDx Offers Personalized Transplant Care Through Precision Medicine

MMDx is providing a new understanding of an organ's reduced function in response to injury, even in samples without histological evidence of inflammation. This represents a novel clinical breakthrough for the management of post-transplant kidney and heart patients, particularly when applied alongside a histopathologist’s assessment.

MMDx uses microarray technology to measure mRNA transcript levels in biopsies with high precision (>99%)1. An algorithm is then applied to quantitively score2 the transcript levels and produce a report to help stratify rejection and injury risk in patients.

The Molecular Microscope Diagnostic System was developed by Dr. Philip F. Halloran, leader of the Alberta Transplant Applied Genomics Center (ATAGC). MMDx testing services are performed by Kashi Clinical Laboratories, Inc., a CLIA-certified laboratory located in Portland, Oregon. Molecular Microscope is a registered trademark of Transcriptome Sciences Inc. 

Interested in learning how MMDx can help provide personalized transplant care through precision medicine? 

We are here to assist. Contact us by phone or email.

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  1. K. S. Madill-Thomsen et al. Discrepancy Analysis Comparing Molecular and Histology Diagnoses in Kidney Transplant Biopsies. Am J Transplant Am J Transplant. 2020;20: 1314-1350
  2. J. Reeve et al. Generating automated kidney transplant biopsy reports using ensembles of molecular classifiers. Am J Transplant 19 (10): 2719-2731, 2019.


Safe Harbor Statement: This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to coverage with a future effective LCD. Although it is believed that the expectations reflected in the forward-looking statements are reasonable and are based on management’s current expectations of future events, they are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to, uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers’ reimbursement levels for our tests; and risks of new changing and competitive technologies, laws and regulations in the United States and internationally. All information in this communication is as of the date of the release, and One Lambda, Inc. undertakes no duty to update this information unless required by law.