COMPANY:

NeoGenomics

"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."

"NeoGenomics, Inc...announced that its liquid biopsy focused subsidiary Inivata Limited ('Inivata') has entered into a clinical collaboration with the Princess Margaret Cancer Center in Toronto, Canada, for the use of Inivata's liquid biopsy assays, InVisionFirst®-Lung and RaDaR™ in two separate studies."

"NeoGenomics, Inc...announced that its liquid biopsy focused subsidiary Inivata Limited ("Inivata") alongside collaborators, will present new data on its RaDaR™ assay for the detection of molecular residual disease (MRD) and recurrence and on its InVisionFirst®-Lung liquid biopsy test at the European Society for Medical Oncology (ESMO) Congress, taking place on 16-21 September 2021."

"NeoGenomics, Inc...announced today that it has completed its acquisition of Inivata Ltd...Inivata will become a liquid biopsy focused division alongside NeoGenomics' growing clinical, pharma and informatics divisions...'We are particularly enthusiastic about Inivata's highly sensitive RaDaR assay, targeting the emerging and significant opportunity for minimal residual disease testing. We plan on leveraging our established oncology diagnostics leadership position, human capital, strong pharma and clinical market relationships, and robust balance sheet to accelerate the development of this assay.'"

"Inivata...today announced a collaboration with F-star Therapeutics, Inc...for the use of Inivata’s RaDaR technology. Under the collaboration, Inivata’s RaDaR technology, a personalized assay that tracks a set of up to 48 tumor-specific variants in a patient using a liquid biopsy with exceptional sensitivity, will be applied to identify and evaluate potential early biomarkers of clinical efficacy.."

"NeoGenomics, Inc...announced today that it has agreed to acquire Inivata Ltd, a global, commercial stage liquid biopsy platform company headquartered in Cambridge, England...'we expect to accelerate the development of our promising RaDaR minimal residual disease (MRD) assay and accelerate commercialization efforts with biopharma before driving a successful launch into the clinical setting'"

"Inivata...today announced it has entered a commercialization agreement with Agendia, Inc...Under the terms of the agreement, Agendia will gain co-exclusive rights to distribute Inivata’s RaDaR® liquid biopsy assay for the detection of Minimal Residual Disease (MRD) and early detection of relapse in patients with breast cancer in North America and Europe, with the option of extending territories over time. It is expected that the RaDaR assay will be reimbursed and available to clinicians in the US during 2022."

"NeoGenomics, Inc...is excited to launch an Amgen-sponsored testing program to support single-gene molecular testing for the biomarker KRAS G12C for eligible lung cancer patients at no cost to the patient...As part of Amgen's Biomarker AssistTM KRAS Single Gene Testing Program, Amgen will sponsor testing for the KRAS G12C biomarker for patients suffering from advanced or metastatic (stage IV) non-small cell lung cancer (NSCLC) through NeoGenomics. The sponsored testing program will leverage NeoGenomics' experience in biomarker testing, with Amgen funding the total cost of the tests performed by NeoGenomics, regardless of patient's insurance coverage or test results."

"NeoGenomics, Inc...announced today that it has agreed to acquire Intervention Insights, Inc. d/b/a Trapelo Health, an Information Technology company focused on precision oncology...'The addition of Trapelo to NeoGenomics significantly enhances our ability to provide customers with information to help them answer difficult and complex questions related to precision oncology biomarker testing and treatment options.'"

"NeoGenomics, Inc...and Elevation Oncology...announced today a collaboration to enhance identification of patients with any solid tumor harboring an NRG1 fusion who may be eligible for enrollment in the Phase 2 CRESTONE study."

"Inivata...today announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its RaDaR™ assay. RaDaR is a personalized assay that tracks a set of up to 48 tumor-specific variants in a patient using a liquid biopsy with exceptional sensitivity. The assay potentially allows detection of residual disease following initial treatment and early detection of relapse."

"Parexel…and NeoGenomics…today announced a strategic partnership to advance the application of precision medicine in oncology clinical trials by applying real-world genomics data to accelerate patient matching and optimize trial design, site selection, clinical development and translational research…The strategic partnership between Parexel and NeoGenomics will enable biopharmaceutical customers to make evidence-based decisions regarding trial designs, companion diagnostics and drug repurposing as well as to build external control arms using genomic data, ultimately providing cancer patients access to the most effective therapies when and where they need them."

"The Access to Comprehensive Genomic Profiling Coalition (ACGP) announced today the addition of NeoGenomics, Inc…and Tempus to its coalition of diagnostics companies and laboratory service providers to advocate for appropriate broad U.S. health insurance coverage of comprehensive genomic profiling (CGP) for patients living with advanced cancer."

"Inivata…today announces it has raised $35 million (£25.7 million) in a second close of a Series C financing round…The funds will primarily be used to accelerate the clinical development and continued rollout of RaDaR™, the Company’s highly sensitive personalized assay for the detection and monitoring of minimal residual disease (MRD) and recurrence…The latest financing will enable Inivata to build a clinical development program which will bring the benefits of RaDaR to patients more directly. In addition, the proceeds will drive the continued commercial rollout of Inivata’s InVisionFirst®-Lung liquid biopsy test."

"Natera…has sued Inivata and its wholly owned subsidiary of the same name for alleged infringement of two of its patents. In its complaint…Natera said Inivata infringes its US Patent Nos. 10,262,755, titled ‘Detecting cancer mutations and aneuploidy in chromosomal segments,’ and 10,597,709, titled ‘Methods for simultaneous amplification of target loci,’ which it said protect intellectual property in the areas of cancer personalized monitoring and molecular residual disease testing. Natera said Inivata infringes these patents by selling, manufacturing, and using various oncology products, including its InVision First-Lung test, which it launched in the US last summer through a partnership with NeoGenomics."

"Inivata…today announces its participation in a major research collaboration to investigate integrated diagnostics for the early detection of lung cancer with the aim of increasing survival rates, alongside improving the efficiency of testing in people at high risk of cancer in the NHS. The program’s goal is to streamline the process of detecting cancers and reduce the NHS resources that are needed in order to find each new case…As part of this, Inivata’s InVision® liquid biospy platform will be used to analyze blood samples provided by individuals with inconclusive CT scan results to detect mutations of circulating tumour DNA (ctDNA) in their plasma."

"NeoGenomics...announced today the launch of a mobile phlebotomy service for its blood-based tests, including InVisionFirst®-Lung, its advanced non-small cell lung cancer liquid biopsy test, and the NeoLAB® liquid biopsy suite of tests encompassing solid tumor and hematologic cancers...NeoGenomics will arrange for the blood sample collection at the patient's desired location and cover the expense of the mobile phlebotomy blood service."

"Inivata…today announces a collaboration with Maverick Therapeutics (‘Maverick’) for the use of Inivata’s RaDaR™ assay for the detection and monitoring of residual disease and recurrence. RaDaR will be used to monitor circulating tumor DNA (ctDNA) in patients enrolled in the Phase 1/2 study of MVC-101, Maverick’s lead program candidate."

"'The results of a genomic cancer test may be a deciding factor in treatment selection, especially for patients with differentiated thyroid cancer who have limited options,'said Marcia S. Brose, M.D....'If we implement comprehensive genomic testing early upon diagnosis to uncover NTRK gene fusions, we may have a deeper understanding of patients’ tumors in aiding treatment decisions."