American Journal of Transplantation study positions GraftAssure as potentially essential in managing immunosuppression treatment in kidney transplant patients with certain cancersGraftAssure used to help avoid overtreatment and preserve patient’s immune systemAs transplant care evolves to include novel therapies, the need for ongoing molecular diagnostic monitoring should continue to grow NASHVILLE, Tenn., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (Nasdaq: IMDX), (iMDx), today an ...

Core Insights - Insight Molecular Diagnostics Inc. (iMDx) is actively participating in two significant industry conferences to showcase its GraftAssure™ technology and its clinical kitted test under development [1][4] - The company aims to highlight the clinical applications of transplant rejection testing, particularly in longitudinal surveillance and therapeutic response monitoring [2][3] Conference Participation - iMDx is hosting a symposium at the IATDMCT annual meeting in Singapore from September 21 to 24, 2025, focusing on the benefits of in-house testing for transplant rejection [2][6] - The company will also present at the ASHI annual meeting in Orlando, Florida, from October 6 to 10, 2025, discussing GraftAssureIQ, a research-use-only test kit [4][8] Technology and Product Development - GraftAssure technology is designed to detect transplant rejection and monitor treatment response, significantly reducing time-to-rejection diagnosis in high-risk kidney transplant patients [3][5] - The GraftAssureDx, currently in development, is expected to be submitted for FDA review by the end of 2025, targeting an estimated $1 billion addressable market for kitted transplant rejection testing [5][15] Strategic Partnerships - iMDx is collaborating with Bio-Rad Laboratories to present on GraftAssureIQ, emphasizing the potential of in-house testing for convenience and efficiency in transplant care [4][5] Market Position - The company is focused on democratizing access to molecular diagnostic testing, particularly for kidney transplant patients, utilizing donor-derived cell-free DNA (dd-cfDNA) as a biomarker for transplant rejection [16][13]

Core Insights - Insight Molecular Diagnostics (iMDx) announced two favorable oral abstracts, including a late-breaking study, to be presented at the World Transplant Congress from August 2 to 6, 2025, in San Francisco [1] Study Findings - The late-breaking study validated iMDx's novel approach to quantifying donor-derived cell-free DNA (dd-cfDNA), showing a positive predictive value (PPV) of 79% at a 25% rejection prevalence, significantly higher than the average 48% from published data [2] - The combined model of relative and absolute dd-cfDNA quantification was able to distinguish all types of rejection from non-rejection pathologies, indicating its dual utility in clinical decision-making [3][4] Clinical Implications - The improved PPV suggests that the dd-cfDNA combination model can serve as both a reliable tool to rule out organ rejection and a meaningful rule-in option, potentially changing the paradigm of dd-cfDNA testing [3] - iMDx's GraftAssure dd-cfDNA combination assay is positioned as an exceptionally useful biomarker for transplant physicians, addressing daily clinical challenges after kidney transplantation [4] Product Development - iMDx is working to bring the innovation into its CLIA lab and into its research-use-only and regulated clinical kitted product pipeline, enhancing diagnostic accuracy by combining two assays into one score [5] - The company is also developing GraftAssureDx and intends to seek regulatory authorization for clinical use, targeting the estimated $1 billion transplant rejection testing market [9] Upcoming Presentations - iMDx will present a second abstract at the World Transplant Congress, reaffirming dd-cfDNA as a noninvasive standard for predicting kidney transplant rejection, with the data selected for prominent discussion during the closing plenary session [6] Company Overview - iMDx, formerly known as Oncocyte Corp., is focused on democratizing access to novel molecular diagnostic testing to improve patient outcomes, with its GraftAssure product lines already achieving Medicare reimbursement [15][17]

Company Overview - Insight Molecular Diagnostics, or iMDx, is a pioneering diagnostics technology company focused on democratizing access to novel molecular diagnostic testing to improve patient outcomes [8] - The company recently moved its headquarters from Irvine, California, to Nashville, Tennessee, with a new NASDAQ symbol effective June 18, 2025 [9] Key Opinion Leader Event - iMDx will host a virtual key opinion leader (KOL) event on August 15, 2025, featuring Dr. Anthony Langone, who is the national principal investigator for iMDx's kidney transplant monitoring trial [1][2] - Dr. Langone will discuss the role of donor-derived cell-free DNA (dd-cfDNA) in transplant care and the benefits of in-house testing [2] GraftAssure™ Product Line - The GraftAssure™ family of assays utilizes advanced digital PCR (dPCR) technology to provide reliable dd-cfDNA results for transplant monitoring [3] - The company is developing a diagnostics test kit for clinical use, allowing hospitals to conduct their own tests in-house [3] - Current products include GraftAssureCore, a lab-developed test reimbursed by CMS, and GraftAssureIQ, a research-use-only kit [6][7] Future Developments - iMDx is working on GraftAssureDx, an in vitro diagnostic kit intended for clinical decision-making, which will be submitted for FDA authorization [7] - The company aims to commercialize its technology using a market-disruptive approach, establishing dd-cfDNA as a trusted biomarker for transplant rejection [6]

Core Insights - Insight Molecular Diagnostics (iMDx) announced positive results from a study comparing its GraftAssureIQ test kit with another commercially available test kit, showing equivalent measurements of donor-derived cell-free DNA (dd-cfDNA) [1][3][5] - The company aims to launch its first clinical molecular diagnostic test kit, targeting the estimated $1 billion transplant rejection testing market [2][15] - The study, conducted by the University Hospital Heidelberg, represents the first direct comparison of two commercially available dd-cfDNA test kits, one using next-generation sequencing (NGS) and the other using digital polymerase chain reaction (digital PCR) [4][5] Study Details - The study evaluated 96 kidney transplant recipients and demonstrated that both platforms provided consistent results, reinforcing the reliability of dd-cfDNA testing in routine transplant care [5][8] - Digital PCR showed improved analytical sensitivity compared to NGS, suggesting potential advantages in detecting dd-cfDNA in low quantities [3][5] - Extended data from the study will be presented at the upcoming European Society of Organ Transplantation (ESOT) Congress in London [7][8] Product Development - GraftAssureIQ is currently a research-use-only kit, while iMDx is developing GraftAssureDx for clinical use and intends to seek regulatory authorization [6][16] - The company has transitioned its headquarters from Irvine, California, to Nashville, Tennessee, and its NASDAQ symbol changed to IMDX [14] - iMDx's transplant diagnostics include GraftAssureCore, which is a lab-developed test currently reimbursed by CMS [15]

Core Insights - Insight Molecular Diagnostics Inc. has rebranded from Oncocyte Corporation and relocated its headquarters to Nashville, Tennessee, with a new stock symbol "IMDX" effective June 18, 2025 [1][2][3] Company Strategy - The rebranding reflects the company's expanded strategic direction beyond oncology, now including a focus on transplant medicine, aiming to deliver a molecular diagnostic kit for kidney transplant patients [2][3] - The company targets a $1 billion addressable market for transplant rejection testing and is transitioning from product development to commercialization [3][4] Operational Changes - The relocation to Nashville aligns operations with the company's CLIA-certified lab and healthcare innovation hub, while maintaining a laboratory in Göttingen, Germany [4] - The company is unifying its transplant diagnostics under the GraftAssure brand, retiring the VitaGraft name [11][16] Product Development - The GraftAssure product line includes GraftAssureCore (lab-developed test), GraftAssureIQ (research-use-only kit), and GraftAssureDx (in vitro diagnostic kit in development) [11][12][16] - The company is actively participating in the European Society for Organ Transplantation (ESOT) Congress to promote its GraftAssureIQ pilot site program [7][9] Branding and Identity - The new logo symbolizes the company's commitment to healthcare providers and reflects its mission to provide insights through science [5][6] - The rebranding leverages existing rights to the name Insight Genetics, acquired in 2020, and emphasizes a healthcare provider-centric philosophy [5][6]

Core Insights - Oncocyte Corp. has announced a positive update regarding the pricing of its next-generation lab-developed test (LDT), GraftAssureCore, which enhances its position in the transplant rejection testing market and indicates potential growth in its estimated $1 billion total addressable market [1][6] Pricing and Reimbursement - The Centers for Medicare & Medicaid Services (CMS) has increased the reimbursement rate for GraftAssureCore to $2,753 per result, up from $2,222 for first-time testing and $1,029 for subsequent tests [2] - This new pricing aligns with existing competitive technologies and expands market appeal for future FDA-cleared kitted products at transplant centers [6] Company Strategy and Future Prospects - Oncocyte has invested significantly in improving the scalability and manufacturability of its workflow, which supports its kitted test program [3] - The new reimbursement rate establishes a benchmark for future kitted tests, such as GraftAssureDx, which is expected to be submitted for FDA review by the end of the year [3] - The company anticipates that receiving FDA authorization will enable broader adoption of its technology, allowing transplant centers to access high-quality, FDA-cleared kits with established reimbursement [4] Clinical Trials and Market Engagement - Oncocyte has received approval from a Central Institutional Review Board for its clinical trial, with final preparations underway at participating transplant centers [4] - The company expects participation from three of the top 10 U.S. transplant centers, representing nearly 10% of annual U.S. transplant volume [4] Technology and Market Position - Oncocyte's technology quantifies donor-derived cell-free DNA (dd-cfDNA), which has been established as a trusted biomarker for transplant rejection [5] - The company is rebranding its test portfolio under the GraftAssure brand, with GraftAssureCore being the new name for its previously marketed VitaGraft assay [5]