Insight Molecular Diagnostics to Showcase Leadership in Kidney Transplant Management at Conferences in Singapore and Orlando
Insight Molecular Diagnostics (NASDAQ:IMDX) announced its participation in two major industry conferences to showcase its GraftAssure™ transplant rejection testing technology. The company will host a symposium at the IATDMCT annual meeting in Singapore (September 21-24) and present at the ASHI annual meeting in Orlando (October 6-10).
IMDX will discuss its GraftAssureIQ™ research-use-only test kit and the development of GraftAssureDx™, its clinical kitted test. Both tests measure donor-derived cell-free DNA (dd-cfDNA) for transplant rejection detection. The company plans to submit GraftAssureDx for FDA review by year-end and estimates an addressable market of $1 billion for kitted transplant rejection testing.
Insight Molecular Diagnostics (NASDAQ:IMDX) ha annunciato la sua partecipazione a due grandi conferenze di settore per presentare la tecnologia di test per il rigetto del trapianto GraftAssure™. L'azienda terrà un simposio all'IATDMCT annual meeting a Singapore (21-24 settembre) e parteciperà all'ASHI annual meeting a Orlando (6-10 ottobre).
IMDX discuterà del suo kit di test per uso di ricerca GraftAssureIQ™ e dello sviluppo di GraftAssureDx™, il suo test clinico in kit. Entrambi i test misurano dd-cfDNA per la rilevazione del rigetto dei trapianti. L'azienda prevede di presentare GraftAssureDx per la revisione FDA entro la fine dell'anno e stima un mercato indirizzabile di $1 miliardo per i test di rigetto del trapianto in kit.
Insight Molecular Diagnostics (NASDAQ:IMDX) anunció su participación en dos importantes conferencias de la industria para presentar su tecnología de prueba de rechazo de trasplante GraftAssure™. La compañía organizará un simposio en la IATDMCT annual meeting en Singapur (21-24 de septiembre) y presentará en la ASHI annual meeting en Orlando (6-10 de octubre).
IMDX discutirá su kit de prueba GraftAssureIQ™ para uso de investigación y el desarrollo de GraftAssureDx™, su prueba clínica en formato kit. Ambas pruebas miden dd-cfDNA para la detección del rechazo de trasplantes. La empresa planea presentar GraftAssureDx para revisión de la FDA antes de fin de año y estima un mercado direccionable de $1 mil millones para pruebas de rechazo de trasplantes en formato kit.
Insight Molecular Diagnostics (NASDAQ:IMDX)는 이식 거부 테스트 기술인 GraftAssure™를 선보이기 위해 두 개의 주요 업계 컨퍼런스에 참여한다고 발표했다. 이 회사는 싱가포르에서 열리는 IATDMCT annual meeting에서 심포지엄을 개최하고(9월 21-24일) 올랜도에서 열리는 ASHI annual meeting에서 발표할 예정이다(10월 6-10일).
IMDX는 연구용으로 사용되는 GraftAssureIQ™와 임상 키트 테스트인 GraftAssureDx™의 개발에 대해 논의할 것이다. 두 테스트 모두 dd-cfDNA를 측정해 이식 거부를 탐지한다. 연말까지 GraftAssureDx를 FDA 심사에 제출할 계획이며, 키트 형식의 이식 거부 테스트 시장 규모를 10억 달러로 추정한다.
Insight Molecular Diagnostics (NASDAQ:IMDX) a annoncé sa participation à deux grandes conférences du secteur pour présenter sa technologie de test de rejet de greffe GraftAssure™. La société organisera un symposium lors de la IATDMCT annual meeting à Singapour (21-24 septembre) et prendra la parole lors de l'ASHI annual meeting à Orlando (6-10 octobre).
IMDX discutera de son kit GraftAssureIQ™ destiné à un usage en recherche et du développement de GraftAssureDx™, son test clinique sous forme de kit. Les deux tests mesurent le dd-cfDNA pour la détection du rejet de greffe. L'entreprise prévoit de soumettre GraftAssureDx à l'examen de la FDA d'ici la fin de l'année et estime un marché adressable d'environ $1 milliard pour les tests de rejet de greffe en kit.
Insight Molecular Diagnostics (NASDAQ:IMDX) hat seine Teilnahme an zwei großen Branchenkonferenzen angekündigt, um seine GraftAssure™-Transplantat-Abstoßungstests-Technologie zu präsentieren. Das Unternehmen wird ein Symposium auf dem IATDMCT annual meeting in Singapur (21.–24. September) ausrichten und beim ASHI annual meeting in Orlando (6.–10. Oktober) präsentieren.
IMDX wird über seinen GraftAssureIQ™-Forschungstestkit und die Entwicklung von GraftAssureDx™, seinem klinischen Kit-Test, sprechen. Beide Tests messen dd-cfDNA zur Erkennung der Transplantat-Abstoßung. Das Unternehmen plant, GraftAssureDx noch in diesem Jahr bei der FDA zur Prüfung vorzulegen, und schätzt einen adressierbaren Markt von $1 Milliarde für gekittete Transplantat-Abstoßungstests.
Insight Molecular Diagnostics (NASDAQ:IMDX) أعلنت عن مشاركتها في مؤتمرَين صناعيَّين رئيسيَّين لعرض تقنية اختبار رفض الزرع GraftAssure™. ستستضيف الشركة ندوة في IATDMCT annual meeting في سنغافورة (21-24 سبتمبر) وتقدم عرضًا في ASHI annual meeting في أورلاندو (6-10 أكتوبر).
ستناقش IMDX مجموعة GraftAssureIQ™ للاستخدام البحثي وتطوير GraftAssureDx™، اختبارها الإكلينيكي في عبوات. كلا الاختبارين يقيسان dd-cfDNA للكشف عن رفض الزرع. تخطط الشركة لتقديم GraftAssureDx لمراجعة إدارة الغذاء والدواء (FDA) قبل نهاية السنة وتقدر سوقًا قابلاً للوصول بمبلغ $1 مليار لاختبارات رفض الزرع في عبوات.
Insight Molecular Diagnostics (NASDAQ:IMDX)宣布将参与两场重要行业会议，以展示其 GraftAssure™ 移植物排斥检测技术。公司将在新加坡举行的 IATDMCT annual meeting（9月21-24日）举办研讨会，并在奥兰多举行的 ASHI annual meeting（10月6-10日）进行演讲。
IMDX 将讨论其用于研究用途的 GraftAssureIQ™ 试剂盒以及其正在开发的 GraftAssureDx™，这是其临床成对试剂盒测试。两项测试均测量捐献者来源的游离DNA (dd-cfDNA)，用于移植排斥的检测。公司计划在今年年底前提交 GraftAssureDx 给 FDA 审查，并估计用于成对移植排斥检测的可及市场约为 $1 十亿美元。
- GraftAssureIQ is already commercially available for research use since summer 2024
- Clinical study for FDA clearance is progressing at leading transplant centers
- Strategic partnership with Bio-Rad Laboratories strengthens market position
- Technology significantly reduces time-to-rejection diagnosis in high-risk kidney transplant patients
- Large addressable market estimated at $1 billion for kitted transplant rejection testing
- None.
- IMDX to host symposium on Wednesday, September 24th to discuss GraftAssureIQ™ at International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) annual meeting
- Presenting on GraftAssureIQ at symposium on Thursday, October 9th at the American Society of Histocompatibility and Immunogenetics (ASHI) annual meeting
NASHVILLE, Tenn., Sept. 24, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (Nasdaq: IMDX), (iMDx), today announced attendance at two key industry conferences where it will discuss its GraftAssure™ technology, including its clinical kitted test under development.
At the 23rd IATDMCT annual meeting, which is being held September 21st to 24th in Singapore, iMDx will host a symposium to discuss the growing clinical applications of transplant rejection testing into longitudinal surveillance and therapeutic response monitoring, and the benefits of in-house testing.
The symposium will highlight how GraftAssure, which is iMDx’s flagship transplant rejection testing technology, can be used to detect transplant rejection, as well as to monitor treatment response in patients. The presentation will also include previously published data showcasing how iMDx’s flagship transplant rejection testing technology significantly reduces time-to-rejection diagnosis in certain high-risk kidney transplant patients.
“Kidney transplant management is changing. Emerging medications such as anti-CD38 therapies have a chance at treating transplant rejection, and in-house testing will bring care where it belongs – closer to the patient,” said iMDx CEO Josh Riggs. “Our presentations this fall in both Singapore and Orlando highlight the bright potential of our technology and the strong global interest in our assay.”
In addition, both iMDx and its strategic investor and partner, Bio-Rad Laboratories, will be presenting on GraftAssureIQ, which is iMDx’s research-use-only test kit, at the 51st ASHI annual meeting, which will be held October 6th to 10th in Orlando, Fla. The presentation will feature iMDx Chief Science Officer Dr. Ekke Schuetz as well as others, including Bio-Rad Southeast Field Application Scientist Regional Manager Eric Johnson, PhD. In addition to discussing how the GraftAssureIQ kits enable much-needed scientific research, the presentation will also highlight the promising potential of in-house transplanted organ rejection testing, which will offer convenience and efficiency for patients, physicians, laboratory managers and hospital administrators.
“We are pleased to be able to communicate the value of our kitted test to the many thought leaders in transplant and diagnostics who will be at the annual ASHI meeting,” said Chief Science Officer Dr. Ekke Schuetz. “Our goal is to enable precise and accessible in-house dd-cfDNA testing for hospitals and particularly their kidney transplant patients. Our ongoing study to support regulatory clearance of our clinical kitted assay is well underway at leading transplant centers and we look forward to submitting GraftAssureDx for FDA review by year end.”
GraftAssureIQ became available for purchase in summer 2024 for research use only, while GraftAssureDx is being developed as a clinical molecular diagnostic test kit, to expand and improve testing access for kidney transplant patients. The company expects that the clinical kitted version of its assay will deliver new value in the estimated
Conference information:
IATDMCT 2025 Symposium (Singapore)
Title: “Donor-derived cell-free DNA for Personalized Immunosuppression in Transplantation”
Speakers: Michael Oellerich, MD, (George-August University, Göttingen, Germany), Klemens Budde, MD, (Charité University, Berlin, Germany), and Geoff Bien (iMDx)
Date: Wednesday, September 24, 2025
Time: 12:30 pm -1:25 pm SGT
ASHI Annual Meeting (Orlando, Fla.)
Title: “GraftAssureIQ: Enabling In-House dd-cfDNA Testing in Transplant Research”
Speakers: Ryan Andrews (iMDx), Eric Johnson, PhD, (Bio-Rad), Geoff Bien (iMDx), and Ekke Schuetz, MD, PhD (iMDx)
Date: Thursday, Oct 9, 2025
Time: 12:40 pm – 1:35 pm ET
About IATDMCT and the Annual Meeting
The IATDMCT is an organization formed by an international group of scientists and physicians, to promote the related disciplines of therapeutic drug monitoring (TDM) and clinical toxicology worldwide. IATDMCT is unique in that no other society promotes the interest of TDM and clinical toxicology internationally.
IATDMCT 2025 brings together leading international scientists and healthcare professionals who are actively working in the fields of TDM and Clinical Toxicology. The theme of the congress is Creative solutions for global challenges. The congress will consist of world class plenary speakers, innovative symposia and practical workshops across all the major areas of therapeutics and toxicology with a unique Asia Pacific flavor. The congress will provide the opportunity for researchers and clinicians from around the world to come together and share their research and experiences in TDM, basic and clinical and translational pharmacology and clinical toxicology.
For more information, visit: https://www.iatdmct2025.org/
About ASHI and the Annual Meeting
The American Society for Histocompatibility and Immunogenetics (ASHI) is a society of professionals dedicated to advancing the science, education and application of immunogenetics and transplant immunology.
The ASHI Annual Meeting is the largest and most successful event of the year, drawing over 1,000 attendees from around the world who specialize in histocompatibility, immunogenetics and transplant immunology. Attendees are society members and non-members of the society, industry partners, technologists, researchers, and trainees who join together to share updates on immunogenetics and immunology research as well as practical guidelines in clinical histocompatibility and immunogenetics. The 2025 Annual Meeting is at the Hyatt Regency Grand Cypress on October 6 - 10, 2025 in Orlando, FL. This five-day interactive conference will connect you to HLA professionals and the latest updates in immunogenetics and transplant immunology.
For information, visit https://www.ashi-hla.org/page/Meetings.
iMDx Transplant Products and Product Candidates in Development
The company’s flagship transplant testing technology quantifies a molecular biomarker known as donor-derived cell-free DNA (dd-cfDNA). The company’s scientists in Germany and the U.S. have played a crucial role over the past decade in developing the science that helped establish dd-cfDNA as a trusted biomarker of transplant rejection, and iMDx is now commercializing that technology using a market disruptive approach. Its transplant diagnostics under the GraftAssure brand include the following:
- GraftAssureCore – The company’s laboratory-developed test (LDT), currently reimbursed by CMS and performed at its CLIA-certified laboratory in Nashville. The company is in the process of rebranding its VitaGraft assay (previously known as VitaGraft Kidney), which is a lab developed test, under the name GraftAssureCore. For purposes of this press release, references to “GraftAssureCore” shall be deemed to include the test previously marketed as VitaGraft.
- GraftAssureIQ – A research-use-only (RUO) kit intended and labeled for non-clinical applications.
- GraftAssureDx – The in vitro diagnostic (IVD) kit currently in development for use in clinical decision-making, which the company intends to submit for FDA authorization in 2025.
About Insight Molecular Diagnostics Inc.
Insight Molecular Diagnostics Inc., or iMDx, formerly Oncocyte Corp. (OCX), is a pioneering precision diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes. iMDx utilizes a well-established proprietary approach to quantify dd-cfDNA, which is a widely used molecular biomarker of transplant rejection.
iMDx™, GraftAssure™, GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, and VitaGraft™ are trademarks of Insight Molecular Diagnostics Inc.
Insight Molecular Diagnostics (Nasdaq: IMDX) moved its headquarters from Irvine, Calif., to Nashville, Tenn., in June 2025. The company’s new NASDAQ symbol became effective June 18. Investors may visit https://investors.imdxinc.com/ for more information.
Forward-Looking Statements
Any statements that are not historical fact (including, but not limited to, statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to, among other things, iMDx’s participation at IATDMCT and ASHI, the expected submission of GraftAssureDx for FDA review by the end of the year, iMDx’s GraftAssure technology (including GraftAssureIQ and GraftAssureCore), and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of iMDx’s third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests iMDx or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of iMDx, particularly those mentioned in the “Risk Factors” and other cautionary statements found in iMDx’s Securities and Exchange Commission (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. iMDx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Investor Contact:
Doug Farrell
LifeSci Advisors LLC
dfarrell@lifesciadvisors.com
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