DetermaIO™

Search documents
iMDx to Participate in NYC Investment Conferences September 8 - 11
Globenewswire· 2025-08-26 20:05
Group 1 - Insight Molecular Diagnostics Inc. (iMDx) announced participation in investor conferences hosted by H.C. Wainwright and Lake Street Capital Markets [1] - The H.C. Wainwright 27th Annual Global Investment Conference will take place on September 8-9, 2025, featuring a company presentation on September 8 at 5:00 pm ET [1] - The Lake Street Capital Markets 9th Annual Best Ideas Growth Conference (BIG9) is scheduled for September 11, 2025, with a format of one-on-one meetings [1] Group 2 - Insight Molecular Diagnostics is focused on democratizing access to novel molecular diagnostic testing to improve patient outcomes [2] - The company holds several trademarks, including GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™ [2]
IMDX Reports Q2 2025 Results and Momentum Toward GraftAssureDx Launch
Globenewswire· 2025-08-11 20:05
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]
Oncocyte to Participate in 24th Annual Needham Virtual Healthcare Conference
Globenewswire· 2025-04-02 12:45
Core Insights - Oncocyte Corp. will participate in the 24th Annual Needham Virtual Healthcare Conference from April 7-10, 2025, with CEO Josh Riggs and CFO Andrea James attending [1][3] - The focus of the discussion will be on Oncocyte's innovative diagnostic technologies and the progress towards commercializing a regulated organ transplant rejection monitoring test kit [2][4] Company Overview - Oncocyte is a diagnostics technology company that provides tests aimed at enhancing clarity and confidence for physicians and patients [4] - Key products include: - VitaGraft™: A clinical blood-based solid organ transplantation monitoring test - GraftAssure™: A research use only (RUO) blood-based solid organ transplantation monitoring test - DetermaIO™: A gene expression test for predicting response to immunotherapies - DetermaCNI™: A blood-based monitoring tool for assessing therapeutic efficacy in cancer patients [4][5]