NASHVILLE, Tenn., Aug. 26, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., or iMDx, (Nasdaq: IMDX), today announced participation in investor conferences hosted by both H.C. Wainwright and Lake Street Capital Markets. Information for each can be found below: Event: H.C. Wainwright 27th Annual Global Investment ConferenceDate: September 8 – 9, 2025Location: In-person at the Lotte New York Palace Hotel and virtual Format: Company presentation on Monday, September 8 at 5:00 pm ET, and one-on-one m ...

Core Insights - Insight Molecular Diagnostics Inc. (iMDx) is progressing towards delivering a regulated kitted transplant monitoring assay, GraftAssureDx, to the market, aiming to capture a share of the $1 billion transplant rejection testing market [1][2][4] Regulatory and Product Development - The company is focused on designing a complex molecular lab test in a kitted form to facilitate localized diagnostic testing, with plans to submit GraftAssureDx for FDA review by the end of 2025 [2][7] - iMDx has made significant strides in its clinical trial, engaging leading transplant hospitals, and has received positive feedback from the FDA during meetings [8][11] - The company aims to democratize access to transplant rejection tests by obtaining regulatory authorization, allowing hospitals to conduct tests independently [4][6] Financial Performance - In Q2 2025, iMDx reported revenues of $518,000, primarily from laboratory services and initial sales of GraftAssureIQ kits, with a gross profit of $350,000, reflecting a gross margin of 67.6% [15][18] - Operating expenses for Q2 2025 totaled $10.2 million, with a net loss of $9.7 million, or ($0.30) per share, indicating ongoing investment in product development and regulatory processes [18][26] Market Strategy and Future Outlook - The company is implementing a "Land and Expand" strategy, starting with research-use-only kits to familiarize hospitals with their assays before transitioning to diagnostic kits upon regulatory approval [9][15] - iMDx is also exploring expansion opportunities beyond kidney transplant testing, including heart, lung, and liver transplant rejection testing, leveraging the same cfDNA platform [12][14] - The company has received a boost in Medicare reimbursement for its flagship technology, GraftAssureCore, which sets a benchmark for future kitted test reimbursement [8][9]

Investor Presentation NASDAQ:IMDX August 2025 iMDxinc.com Forward-Looking Statements Safe-Harbor Statement This presentation and the accompanying oral presentation contain "forward-looking" statements that are based on the Insight Molecular Diagnostics, Inc.'s (iMDx) management's beliefs and assumptions and on information currently available to management. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipate ...

Core Insights - Oncocyte Corp. is focused on launching its first clinical molecular diagnostic test kit for transplant rejection testing, targeting a $1 billion market opportunity [1][8][25] - The company reported $2.1 million in pharma services revenue for Q1 2025, with gross margins improving from 40% in Q4 2024 to 62% in Q1 2025 due to operational efficiencies [2][31] Clinical Trial Progress - Oncocyte has completed the clinical trial design for its diagnostic testing kit and received approval from a central institutional review board (IRB) [4] - The company expects participation from at least three of the top 10 transplant centers in the U.S., which represent nearly 10% of U.S. transplanted organ volume [5][7] - The upcoming clinical trial is anticipated to meet clinical evidence requirements for FDA submission, with clearance expected in 2026 [8] Business Update - Ten leading transplant centers are currently using Oncocyte's GraftAssure research-use-only kits, with plans to expand to at least 20 centers by the end of 2025 [11] - The GraftAssure test is expected to generate annual revenue of several hundred thousand dollars up to $2 million per center once FDA clearance is achieved [11] - The company is rebranding its product portfolio, with GraftAssure becoming the umbrella brand for its dd-cfDNA test portfolio [24][22] Financial Overview - Q1 2025 revenues were $2.14 million, with a gross profit of $1.33 million, reflecting a 62% gross margin [31][36] - Operating expenses for Q1 2025 totaled $8.1 million, leading to a net loss of $6.7 million, or ($0.26) per share [31][36] - The company ended Q1 2025 with $32.7 million in cash and equivalents, bolstered by a recent financing round [31][38]