#IMDX

StockTitan

@stocktitan.net

2 days ago

Second Study Affirms Superiority of iMDx GraftAssure Assay’s Proprietary dd-cfDNA Combination Model Score Insight Molecular Diagnostics (Nasdaq: IMDX) highlighted a peer-reviewed study of 249 biopsy-matched kidney transplant patients showing its GraftAssure Combination Model (CM) score outperformed percentage-only and absolute dd-cfDNA measures in correlating with four histopathology-derived rejection indices.The company cites a prior World Transplant Congress readout showing a rise in positive predictive value to over 80% at 25% prevalence, and plans to commercialize an IVD kit in 2026 to address a roughly $2 billion transplant testing market.

#IMDX Second Study Affirms Superiority of iMDx GraftAssure Assay’s Proprietary dd-cfDNA Combination Model Score

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StockTitan

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1 week ago

Insight Molecular Diagnostics Completes Key Milestones Advancing GraftAssureDx Toward FDA Submission Insight Molecular Diagnostics (Nasdaq: IMDX) completed key milestones in February 2026 advancing GraftAssureDx toward an FDA De Novo IVD submission. Milestones include a three-site reproducibility study, collection of sufficient clinical samples based on a projected 25–30% rejection rate, and ISO 13485 certification (Feb. 26).Internal analytical work is nearly complete: about 11,660 of 12,000 instrument and assay cycles finished (roughly 340 remain). Certification enables planned U.K. and EU submissions and supports commercial manufacturing readiness in 2026.

#IMDX Insight Molecular Diagnostics Completes Key Milestones Advancing GraftAssureDx Toward FDA Submission

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StockTitan

@stocktitan.net

2 months ago

Diagnostics company offers 1-on-1 investor meetings in SF and Utah iMDx will hold 1-on-1 meetings with investors during JPM Week in San Francisco on Jan. 12-14 and at BTIG’s Snowbird conference Feb. 9-11.

#IMDX iMDx Announces “JPM Week” and “BTIG Snowbird” Conference Participation

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StockTitan

@stocktitan.net

2 months ago

iMDx to Welcome Industry Veteran as Vice President of Medical Affairs to Prepare for Commercial Transplant Assay Launch Insight Molecular Diagnostics (Nasdaq: IMDX) appointed Dr. Nick Ioannou as Vice President, Medical Affairs effective Jan 6, 2026. Dr. Ioannou brings more than three decades of clinical and medical-affairs experience across organ transplant, nephrology, cardiology, genetics, and oncology.The hire positions iMDx to support its upcoming commercial transplant rejection assay launch, leveraging his field-based KOL relationships and prior roles at Guardant Health, Natera, CSL Behring, Fresenius, and Baxter.

#IMDX iMDx to Welcome Industry Veteran as Vice President of Medical Affairs to Prepare for Commercial Transplant Assay Launch

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StockTitan

@stocktitan.net

2 months ago

iMDx Prepares for U.S. Commercial Launch of GraftAssureDx as Clinical Trial Nears Completion Insight Molecular Diagnostics (Nasdaq: IMDX) provided a year-end update on its GraftAssure transplant diagnostics program and regulatory progress on GraftAssureDx. The company said ~95% of its planned FDA IVD de novo submission work was complete at year-end 2025, with final software quality-control items remaining and full submission expected in the coming weeks.Other highlights: 20 global transplant centers engaged by year-end 2025, 17 U.S. centers committed to a registry (≈10% U.S. transplant volume), TÜV SÜD ISO 13485 stage 1 & 2 audits completed, and an accelerated EU/CE/IVDR submission targeted for H1 2026.

#IMDX iMDx Prepares for U.S. Commercial Launch of GraftAssureDx as Clinical Trial Nears Completion

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StockTitan

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4 months ago

#IMDX IMDX Reports Q3 2025 Results and Progress Toward 2026 Commercial Launch

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StockTitan

@stocktitan.net

4 months ago

iMDx to Release Third Quarter 2025 Results on November 10 and Attend Stephens Annual Investment Conference the Following Week Insight Molecular Diagnostics (Nasdaq: IMDX) will report Q3 2025 financial results after market close on November 10, 2025. The company will host a live Zoom webinar and Q&A at 2:00 PM PT / 5:00 PM ET the same day; registration and an archived replay will be available on the company’s investor relations site.Separately, CEO Josh Riggs will attend the Stephens NASH25 Conference in Nashville on November 19, 2025 (event runs November 18–20); investors can request one‑on‑one meetings via their Stephens sales representative.

#IMDX iMDx to Release Third Quarter 2025 Results on November 10 and Attend Stephens Annual Investment Conference the Following Week

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StockTitan

@stocktitan.net

5 months ago

iMDx Welcomes New VP Marketing to Prepare for Commercial Transplant Assay Launch Insight Molecular

#IMDX iMDx Welcomes New VP Marketing to Prepare for Commercial Transplant Assay Launch

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StockTitan

@stocktitan.net

5 months ago

iMDx Reports Kidney Transplant Patient Achieved ‘Immune Reset’ with Novel Therapy and GraftAssure Monitoring Insight Molecular Diagnostics (Nasdaq: IMDX) reported an American Journal of Transplantation case study where its GraftAssure dd-cfDNA assay monitored a 33-year-old kidney transplant patient treated with CD19 CAR-T therapy.GraftAssure testing reportedly confirmed absence of rejection while conventional immunosuppression was stopped, with stable graft function and oncologic remission sustained through about 23 months, suggesting a possible "immune reset." The company notes GraftAssureCore is reimbursed by CMS, GraftAssureIQ became available for RUO in summer 2024, and GraftAssureDx is in development with planned FDA submission in 2025; the firm cites a $1 billion addressable market for kitted transplant testing.

#IMDX iMDx Reports Kidney Transplant Patient Achieved ‘Immune Reset’ with Novel Therapy and GraftAssure Monitoring

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StockTitan

@stocktitan.net

5 months ago

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.

#IMDX Insight Molecular Diagnostics to Showcase Leadership in Kidney Transplant Management at Conferences in Singapore and Orlando

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StockTitan

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6 months ago

Insight Molecular Diagnostics Announces Positive Strategic Update and Novel Registry Database Insight Molecular Diagnostics (NASDAQ:IMDX) announced a strategic initiative to launch a novel registry database for its kidney transplant rejection assay. The registry will enroll 5,000 patients across 25+ centers over three years, collecting approximately 50,000 samples. The program will evaluate the company's unique "combined score" algorithm and the "Berlin protocol" for accelerated testing in high-risk patients.The announcement follows several key milestones in 2025, including claims expansion for dd-cfDNA testing, increased CMS reimbursement to $2,753 for GraftAssureCore, and positive clinical data presented at the World Transplant Congress. The company is targeting an estimated $1 billion addressable market for transplant rejection testing with its GraftAssure™ product line.

#IMDX Insight Molecular Diagnostics Announces Positive Strategic Update and Novel Registry Database

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StockTitan

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6 months ago

$1B Market Opportunity: iMDx Launches Pivotal Trial for Revolutionary Transplant Rejection Test iMDx initiates 125-patient trial for GraftAssureDx transplant rejection test across 10 leading centers. FDA submission targeted for 2025, with $2,753 Medicare reimbursement approved.

#IMDX IMDX Enrolls First Patient in GraftAssureDx Clinical Trial and Welcomes New Hospital Participants

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StockTitan

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7 months ago

IMDX Reports Q2 2025 Results and Momentum Toward GraftAssureDx Launch Insight Molecular Diagnostics (NASDAQ:IMDX) reported Q2 2025 results and progress toward launching GraftAssureDx, their FDA-submission-pending transplant monitoring assay. The company generated $518,000 in Q2 revenue primarily from laboratory services and initial GraftAssureIQ research kit sales.Key developments include: productive FDA meetings for GraftAssureDx submission planned for end-2025, partnership with leading transplant hospitals including Mayo Clinic and Cleveland Clinic for clinical trials, and increased Medicare reimbursement to $2,753 per test. The company aims to capture share in the $1 billion transplant rejection testing market through their regulated kitted assay strategy.IMDX's enhanced second-generation GraftAssureIQ kits began shipping in June, and new clinical data demonstrated improved rejection prediction capabilities through their proprietary combined scoring system.

#IMDX IMDX Reports Q2 2025 Results and Momentum Toward GraftAssureDx Launch

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StockTitan

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7 months ago

iMDx Announces Two Major Investor Events: Q2 Earnings and Needham Conference Back-to-Back Mark your calendar: iMDx reports Q2 2025 results August 11, followed by Needham Conference presentation. Join live webinar and 1-on-1 meetings. Get details.

#IMDX iMDx to Release Second Quarter 2025 Results on August 11, 2025 and Attend Needham Virtual MedTech and Diagnostics Conference

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StockTitan

@stocktitan.net

7 months ago

IMDX World Transplant Congress Late-Breaking Data Potentially Sets New Bar for Predicting Graft Rejection in Kidney Transplant Patients Insight Molecular Diagnostics (NASDAQ:IMDX) announced groundbreaking late-breaking data at the World Transplant Congress regarding their novel approach to kidney transplant rejection testing. The study, analyzing 403 samples across five clinical cohorts, demonstrated that combining relative and absolute measurements of donor-derived cell-free DNA (dd-cfDNA) achieved a remarkable 79% positive predictive value for graft rejection, significantly higher than the 48% industry average.The company's GraftAssure™ technology demonstrated an impressive 93% negative predictive value and uniquely distinguished all types of rejection from non-rejection pathologies. This breakthrough could potentially transform dd-cfDNA testing paradigms and expand clinical applications in the estimated $1 billion transplant rejection testing market.

#IMDX IMDX World Transplant Congress Late-Breaking Data Potentially Sets New Bar for Predicting Graft Rejection in Kidney Transplant Patients

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Small Cap Strategist

@smcapstrategist.bsky.social

8 months ago

Small-cap stocks in new uptrend in Average Directional Index, Mon Jun 23rd - #INLF #GNLX #DWTX #VVOS #RFIL #PXLM #OLPX #NN #IMDX #CCNE #BASE #TXO #TEN #SQNS - More: crystalequityresearch.com/SmCpStr/ - #smallcap

StockTitan

@stocktitan.net

8 months ago

iMDx Reports Strong Head-to-Head Data in Kidney Transplant Rejection Testing iMDx (NASDAQ:IMDX) announced positive results from a head-to-head study comparing its GraftAssureIQ digital PCR-based test kit with NGS-based technology for kidney transplant rejection testing. The study, conducted at University Hospital Heidelberg, evaluated 96 kidney transplant recipients and demonstrated equivalent measurements between the two platforms in detecting donor-derived cell-free DNA (dd-cfDNA).The company's digital PCR technology showed improved analytical sensitivity in detecting dd-cfDNA in low quantities. This data supports iMDx's preparation for commercial launch following expected regulatory approval in 2026, targeting the estimated $1 billion transplant rejection testing market. Extended study data will be presented at the upcoming European Society of Organ Transplantation Congress in London.

#IMDX iMDx Reports Strong Head-to-Head Data in Kidney Transplant Rejection Testing

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Small Cap Strategist

@smcapstrategist.bsky.social

8 months ago

Small-cap stocks with strong volume declines, Wed Jun 18th - #SNTI #INV #IMDX #EKSO #DXLG #BNTC #ACB #DDD #BPT - More: crystalequityresearch.com/SmCpStr/ - #smallcap

PRISM MarketView

@prismmarketview.bsky.social

8 months ago

Close-up image of laboratory equipment, including test tubes, a pipette dispensing liquid, and a microscope, symbolizing advanced diagnostics and precision testing by Insight Molecular Diagnostics.

Oncocyte has a new name and a bold new vision — meet Insight Molecular Diagnostics ( #iMDx). Now trading under #IMDX, the company is doubling down on precision transplant and oncology testing, with its sights set on a $1B global diagnostics market.
prismmarketview.com/oncocyte-reb...