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NASHVILLE - Insight Molecular Diagnostics Inc. (NASDAQ:IMDX), a $96 million market cap diagnostics company showing strong momentum with a 21% gain over the past six months, reported Monday that its GraftAssure test successfully monitored a kidney transplant patient who developed lymphoma and required cessation of traditional immunosuppression treatment.
According to a study published in the American Journal of Transplantation, the molecular diagnostic test confirmed the absence of organ rejection in a 33-year-old patient who underwent CD19 CAR-T therapy for post-transplantation lymphoproliferative disorder (PTLD), a type of lymphoma that can develop due to immunosuppression.
The patient maintained stable graft function for approximately two years without immunosuppression while remaining in cancer remission, suggesting what researchers described as an "immune reset" resulting from the treatment.
"Though it is just a case report, it clearly underscores that our assay measuring dd-cfDNA functioned as a reliable tool to confirm absence of rejection in a rare clinical scenario," said iMDx Chief Science Officer Dr. Ekke Schuetz in the press release.
The GraftAssure test measures donor-derived cell-free DNA (dd-cfDNA), a biomarker of transplant rejection. The company offers GraftAssureCore, a laboratory-developed test currently reimbursed by Medicare, and GraftAssureIQ for research use. A clinical diagnostic test kit called GraftAssureDx is in development with planned FDA submission in 2025.
The company, which recently relocated its headquarters from California to Tennessee and changed its ticker symbol from OCX to IMDX, estimates a $1 billion addressable market for kitted transplant rejection testing. According to InvestingPro data, IMDX maintains a healthy balance sheet with more cash than debt and strong liquidity ratios, though analysts don’t expect profitability this year.
The case highlights a clinical challenge in transplant medicine where treating certain cancers requires reducing immunosuppression that normally prevents organ rejection. The molecular test allowed physicians to monitor the patient’s transplant status throughout cancer treatment without requiring invasive biopsies. With revenue growth exceeding 316% in the last twelve months and current InvestingPro analysis suggesting the stock is undervalued, investors looking for detailed insights can access comprehensive financial analysis and 8 additional ProTips through the platform’s exclusive research reports.
In other recent news, Insight Molecular Diagnostics Inc. reported significant developments, including the launch of a 5,000-patient registry to study its transplant rejection test. This multi-center registry will collect data from kidney transplant patients to evaluate the company’s organ rejection diagnostic test over a span of three years. Additionally, the company granted stock options to several key executives, including CEO Josh Riggs, who received options to purchase 400,000 shares. CFO Andrea James and Chief Science Officer Dr. Ekkehard Schütz each received options for 235,000 shares, while James Liu, Vice President Accounting, Controller, Treasurer, and Principal Accounting Officer, received options for 18,000 shares.
In analyst updates, Needham has reiterated a Buy rating for Insight Molecular Diagnostics, maintaining a price target of $4.25. The firm highlighted positive momentum in the company’s product launches and clinical development. They specifically mentioned the successful progression of the GraftAssureIQ research use only test and the ongoing preparations for the GraftAssureDx Kidney kitted test launch. These developments are part of the company’s broader strategy to enhance its position in the diagnostics market.
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