COMPANY:

NeoGenomics

"NeoGenomics...announced the recent publication of a new study in ESMO Open, demonstrating how circulating tumor DNA (ctDNA) in monitoring molecular residual disease (MRD) may enable earlier identification of disease recurrence for high-risk melanoma patients...Utilizing RaDaR®, NeoGenomics’ next-generation sequencing assay, researchers found that ctDNA detection after surgery can identify patients with worse prognosis, and serial ctDNA measurements may enable earlier identification of disease recurrence."

"NeoGenomics, Inc...will share its latest research on hematologic malignancies and the prognostic effects of microenvironment signatures in primary central nervous system (CNS) lymphoma at the 2024 American Society of Hematology (ASH) Annual Meeting, booth #2347, in San Diego, December 7-10. The company will also feature its robust hematological oncology solutions, including COMPASS, AML Express, and AML MRD Flow Panel."

"NeoGenomics...will present four abstracts at the Association for Molecular Pathology (AMP) 2024...The study highlights the G4 platform as a reliable and efficient alternative for clinical and genomic research applications, delivering high accuracy, speed, and flexibility...The data shows that the TSO500 ctDNA v2 assay maintains high sensitivity for detecting tumor mutations, even with significant genomic DNA contamination, ensuring reliable results for cancer profiling through liquid biopsy...The study validates an improved workflow for the Neo Comprehensive solid tumor genome profiling NGS panel, offering significant time savings and reducing errors while maintaining equivalent accuracy and performance....The data demonstrates that NeoGenomics’ bioinformatics pipeline can identify and classify HPV cases into high and low-risk subtypes with similar performance to more traditional methods, delivering added value and potential cost savings for patients."

"NeoGenomics, Inc...announced today the launch of AML Express, a next-generation sequencing (NGS) assay designed to provide rapid, comprehensive genetic profiling for patients with acute myeloid leukemia (AML)."

"NeoGenomics...NeoGenomics has cleared the feasibility stage with a new version of its RaDaR® technology and has resolved litigation with Natera regarding RaDaR 1.0."

"NeoGenomics, Inc...will present three studies at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, September 13-17 (booth #438). NeoGenomics' data offers key insights into circulating tumor DNA (ctDNA) analysis and next-generation sequencing (NGS), focusing on their role in early diagnosis and treatment optimization."

"NeoGenomics, Inc...will showcase its versatile lung solution and its COMPASS Hematopathology Services portfolio at the American Society of Clinical Oncology (ASCO) conference in Chicago, May 31–June 4 (booth #31093)....NeoGenomics will also feature COMPASS, a suite of single-order sample-to-diagnosis services for hematological malignancies."

"NeoGenomics...will present key findings from 11 abstracts at the American Association for Cancer Research (AACR) 2024 Annual Meeting in San Diego, April 5-10 (booth #915), demonstrating its commitment to advancing cancer patient care through innovative research and development initiatives."

"ConcertAI, LLC and NeoGenomics, Inc announced a broad collaboration to advance large-scale hematological research solutions to investigate real-world clinical practice and outcomes in hematological malignancies."

"NeoGenomics, Inc...announced that NeoGenomics Laboratories, Inc., a subsidiary of NeoGenomics Inc., will appeal the preliminary injunction issued by the United States District Court for the Middle District of North Carolina."

"Natera, Inc...announced that the federal District Court for the Middle District of North Carolina has issued a preliminary injunction, effective immediately, enjoining the RaDaR assay from NeoGenomics Labs, Inc."

"NeoGenomics, Inc...announced new data highlighting its RaDaR assay for minimal residual disease (MRD) will be presented at the 46th annual San Antonio Breast Cancer Symposium (SABCS)."

"NeoGenomics, Inc...announced the commercial availability of two new tests, expanding its cancer portfolio of innovative products. These include Neo Comprehensive - Heme Cancers, a next-generation sequencing (NGS) panel with a comprehensive genomic profile of hematologic malignancies, and Early-stage Non-Small Cell Lung Cancer (NSCLC) Panel, a therapy selection panel designed specifically for early-stage NSCLC patients."

"Natera, Inc...announced that it has filed a lawsuit in the North Carolina Federal District Court against NeoGenomics Labs, Inc. ('NeoGenomics') for infringement of Natera’s U.S. Patent Nos. 11,519,035 and 11,530,454 by NeoGenomics’ RaDaR molecular residual disease assay."

"NeoGenomics, Inc...announced today that the Molecular Diagnostics Services Program (MolDx) has conveyed coverage for the RaDaR assay, a personalized liquid biopsy for minimal residual disease (MRD) and recurrence detection...Following this decision, effective as of March 24, 2023, the RaDaR assay is now covered for fee-for-service Medicare patients within the United States with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer."

"NeoGenomics, Inc...announced that its RaDaR assay, a personalized liquid biopsy for minimal/molecular residual disease (MRD) and recurrence detection, has obtained its first pan-cancer commercial coverage by Blue Shield of California."

"NeoGenomics, Inc...announced new data in support of its RaDaR assay for the detection of molecular residual disease (MRD) and recurrence in patients with high-risk hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer."

"NeoGenomics, Inc...announced new data supporting its cancer tests and treatment guidance tools will be showcased in five poster presentations at the 2023 American Society of Clinical Oncology (ASCO^®) Annual Meeting taking place June 2-6 in Chicago, Illinois....Posters showcasing NeoGenomics' MRD and recurrence monitoring efforts include a Trials in Progress presentation for what is believed to be a first-in-its-kind MRD-directed interventional study in high risk, early stage HER2+ breast cancer, 'KAN-HER2 MRD' (NCT05388149)....Also being presented are findings from five studies using the RaDaR MRD assay in lung, breast, and head and neck cancers, as well as the InVisionFirst^®-Lung liquid biopsy in metastatic non-small cell lung cancer."

"NeoGenomics, Inc...announced today that the company and its collaborators will present a total of nine abstracts at the American Association for Cancer Research (AACR) Annual Meeting 2023 taking place April 14-19, 2023 in Orlando, Florida...NeoGenomics, alongside collaborators, will present new data demonstrating the broad portfolio of services and available validated assays focused on tumor biology, including the use of RaDaR, a personalized, highly-sensitive liquid biopsy sequencing test for the detection of minimal residual disease (MRD) and recurrence."

"Massive Bio, Inc...and NeoGenomics, Inc...announced a collaboration with the goal of accelerating the development of new cancer therapies and ultimately improving the lives of millions of cancer patients around the world."

"NeoGenomics...announced today the commercial availability of the RaDaR® assay, a liquid biopsy test for molecular/minimal residual disease (MRD). MRD is the trace amounts of circulating tumor DNA (ctDNA) that remain after surgery or other cancer treatment."

"NeoGenomics, Inc...announced today the expansion of their next-generation sequencing (NGS) portfolio of innovative products with the commercial availability of multiple tests, including Neo Comprehensive - Solid Tumor, a comprehensive genomic profile (CGP) for solid tumor cancers, and Neo Comprehensive - Myeloid Disorders, a CGP for myeloid neoplasms."

"NeoGenomics, Inc...announced results of a new study of the RaDaR® assay in patients with muscle-invasive bladder cancer immediately following treatment with a combination of the immune checkpoint inhibitors in the neoadjuvant setting. Plasma and urine collected from the patients during treatment was analyzed."

"Natera on Tuesday filed a lawsuit against NeoGenomics subsidiary Inivata, claiming infringement of a new patent it was issued that same day...In a complaint filed with the US District Court of Delaware, Natera alleged that Inivata has unlawfully used its patented technology, covered by US Patent No. 11,530,454, to create its Radar assay, a tumor-informed test for detecting and monitoring residual cancer in patient blood samples."

"NeoGenomics, Inc...and its liquid biopsy-focused subsidiary, Inivata Limited ('Inivata') today announced that new data, being presented at the 45th Annual San Antonio Breast Cancer Symposium (SABCS) taking place on December 6-10, support the use of the RaDaR Assay across all types of early breast cancer in both the adjuvant and surveillance settings."

"NeoGenomics, Inc...today launched a novel biomarker testing program for patients with epithelial ovarian cancer, including primary peritoneal or fallopian tube cancers (EOC).Through the FR-ASSIST™ program, sponsored by ImmunoGen, Inc...EOC patients will have access to the FOLR1 IHC CDx test (VENTANA FOLR1 RxDx Assay) performed by NeoGenomics to measure the expression of a protein called folate receptor alpha (FRα)...The new testing program is sponsored entirely by ImmunoGen and provides eligible EOC patients with FRα-expression testing through NeoGenomics at no cost, regardless of insurance coverage or test results."

"NeoGenomics, Inc...is providing an update on its discussions with MolDX and on its commercial launch activities for RaDaR, its proprietary assay for the detection of minimal residual disease (MRD) and recurrence...Late last week, MolDX informed the Company that additional clinical evidence is needed in order to secure Medicare coverage for RaDaR for Colorectal Cancer (CRC). Specifically, MolDX asked for a direct comparison with other MRD tests being utilized or a full clinical study."

"NeoGenomics, Inc...today announces that its liquid biopsy focused subsidiary Inivata Limited ('Inivata'), alongside collaborators, will present new data on its RaDaR™ assay for the detection of minimal residual disease (MRD) and recurrence at the European Society for Medical Oncology (ESMO) Congress, taking place September 9th-13th, 2022. NeoGenomics and Inivata will host a joint booth in the exhibition hall at the conference."

"Inivata...will present new data on its RaDaR™ assay for the detection of minimal residual disease (MRD) and recurrence at the European Society for Medical Oncology (ESMO) Congress, taking place on 9-13 September 2022. Inivata and NeoGenomics, Inivata’s parent company, will host a joint booth in the exhibition hall at the conference. Data will be presented from the single-center prospective cohort ‘LIONESS’ study in head and neck squamous cell carcinoma (HNSCC) patients receiving primary surgery with curative intent. The study demonstrated that the RaDaR assay was able to detect ctDNA in 100% of cases with confirmed clinical recurrences, highlighting the significant potential of the assay to guide treatment decisions and improve disease outcome."

"NeoGenomics, Inc...confirms that its liquid biopsy focused subsidiary Inivata Limited ('Inivata') has announced new data in support of its RaDaRTM assay for the detection of minimal residual disease (MRD) and recurrence in patients with high-risk hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer."

"NeoGenomics, Inc...announced that its liquid biopsy focused subsidiary Inivata Limited ('Inivata') together with collaborators will present new data on its RaDaR® assay for the detection of minimal residual disease (MRD) and recurrence at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place on 3-7 June 2022. New data on the Company's InVisionFirst®-Lung liquid biopsy test will also be presented."

"NeoGenomics, Inc...announced today that they are partnering with Eli Lilly and Company on a sponsored testing program for eligible patients with metastatic non-small cell lung cancer (NSCLC) at no cost...The Lilly Lung Cancer Sponsored Testing Program will utilize the NeoTYPE® DNA and RNA Assay to provide eligible metastatic NSCLC patients with enhanced access to a targeted genomic test offering that can help physicians and patients make informed treatment decisions. For cases where results are not attainable due to low tissue input or when an invasive biopsy is medically contraindicated, eligible patients are able to instead use InVisionFirst®-Lung Liquid Biopsy at no cost."

"NeoGenomics...announced that its liquid biopsy focused subsidiary Inivata Limited ('Inivata') has unveiled new data at the American Association for Cancer Research (AACR) Annual Meeting further demonstrating the potential of its RaDaR assay for the detection of minimal residual disease (MRD) and recurrence. The data being presented is from the NABUCCO study, which was run in collaboration with the Netherlands Cancer Institute."

P=NA | N=24 | "Inivata...unveils new data at the American Association for Cancer Research (AACR) Annual Meeting further demonstrating the potential of its RaDaR assay for the detection of minimal residual disease (MRD) and recurrence...Inivata is presenting data from a retrospective analysis based on 24 patients from the NABUCCO phase Ib trial in which high-risk resectable urothelial cancer patients received preoperative neo-adjuvant (NeoAdj) treatment of two immune checkpoint inhibitors (ipilimumab and nivolumab)...The study found that following the NeoAdj treatment and prior to surgery, ctDNA was detected in only 7% of patients with pathological complete response to treatment compared to 60% of non-responders (p=0.0088). Of the 17 patients with undetected ctDNA following NeoAdj treatment and before surgery, 13 (76%) had pathological complete response and, importantly, 16 (94%) remained recurrence-free after a median follow-up of 34 months."

"NeoGenomics, Inc...announced that its liquid biopsy focused subsidiary Inivata Limited ('Inivata') has announced the publication of new data in support of its RaDaR™ liquid biopsy test in patients with early-stage non-small cell lung cancer (NSCLC). The data from the LUng cancer CIrculating tumor Dna (LUCID) study have been published in the Annals of Oncology. The study was in collaboration with Cancer Research UK Cambridge Institute, University of Cambridge, Royal Papworth Hospital and Cambridge University Hospital."

"NeoGenomics, Inc...announced that its liquid biopsy focused subsidiary Inivata Limited ('Inivata') has announced clinical validation data for its RaDaR^TM liquid biopsy test in head and neck squamous cell carcinoma (HNSCC). The data from the Liquid BIOpsy for MiNimal RESidual DiSease Detection in Head and Neck Squamous Cell Carcinoma (LIONESS) study have been published in the British Journal of Cancer."

"NeoGenomics, Inc...announced a strategic partnership with the Biomarker Collaborative to help cancer patients who test positive for specific biomarkers connect to support groups that include patients with similar findings..Now, when a lung cancer biomarker is identified through NeoGenomics' testing, the results will include a resource page designed to educate patients on any identified biomarker, and it will connect them to support groups and peers instantly. The resource page is a discussion starting point helping empower patients to better understand their diagnosis with the support of peers walking a similar journey."

"NeoGenomics, Inc...announced that its liquid biopsy focused subsidiary Inivata Limited ('Inivata') has received the CE mark for its RaDaR™ assay for the detection of molecular residual disease (MRD) and recurrence, having met the requirements of the European In-Vitro Diagnostics Directive (98/79/EC). In addition, Inivata has submitted to the MolDX program in the US for the reimbursement of RaDaR for clinical testing."

"Investment bank Cowen on Thursday initiated coverage of NeoGenomics with an Outperform rating and a price target of $42 per share...Cowen sees NeoGenomics' organic growth accelerating as new tests, namely the RaDaR minimal residual disease assay, launch...NeoGenomics to file for Medicare coverage for the test in early 2022, starting with the lung cancer indication, with approval targeted by 2023."

"NeoGenomics, Inc...announced it will use Thermo Fisher Scientific's Ion Torrent Genexus System, the first turnkey next-generation sequencing (NGS) solution that automates the specimen-to-report workflow to deliver results in as little as a single day, in a pharma-sponsored Phase 1 study...As part of the preclinical research investigation, NeoGenomics will receive early access to Thermo Fisher's new Oncomine Myeloid Assay GX v2 to validate the assay on the Genexus System."

"Genetron Holdings Limited...announced that it has entered into a strategic partnership with NeoGenomics, Inc...Genetron Health and NeoGenomics, Inc. will partner globally to provide select harmonized clinical trials, global translational research for pharmaceutical groups and technology platform providers that need a China arm for global or China focused trials. Additionally, NeoGenomics will support Genetron Health on ex-China trials requiring US, APJ and/or EMEA based trials. This will include developing and operating clinical trials for both oncology drugs and their corresponding companion diagnostics (CDx) products."