Tag: cdx

NEW YORK – Roche subsidiary Foundation Medicine and German pharmaceutical company Merck KGaA announced on Monday that they have entered a strategic collaboration to develop companion diagnostics for the US market.  The companies will develop the FoundationOne CDx and FoundationOne Liquid CDx tests as companion diagnostics for selected marketed and…

SAN DIEGO and SAN JOSE, Calif. , June 2, 2023 /PRNewswire/ — Invivoscribe and Complete Genomics announced today that they had entered a partnership to develop and commercialize biomarker tests on Complete Genomics’ NGS platforms. The territory is worldwide, and the field is oncology and cancer research. Under the terms…

Given the shortcomings of conventional biopsy, liquid biopsy offers a different strategy as a cutting-edge diagnostic tool.1 By examining the circulating blood components, it is possible to assess the limiting factors more accurately for better treatment choices—clonal variations and heterogeneity. Additionally, liquid biopsy provides a more accurate representation of the…

New research further confirms value of interrogating epigenomic signals with Guardant Infinity™ platform to identify novel biomarker targets and predict treatment resistance PALO ALTO, Calif., May 31, 2023–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that the company and its research collaborators will present data…

SAN DIEGO, May 26, 2023 /PRNewswire/ — Invivoscribe is pleased to announce that their LeukoStrat CDx FLT3 Mutation Assay® has received updated reimbursement by Japan’s Ministry of Health, Labor and Welfare (MHLW) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be…

SAN DIEGO, May 26, 2023 /PRNewswire/ — Invivoscribe is pleased to announce that their LeukoStrat CDx FLT3 Mutation Assay® has received updated reimbursement by Japan’s Ministry of Health, Labor and Welfare (MHLW) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may…

Samples used in this observational cohort study (tumor tissue and matched healthy colon tissue, AC-ICAM cohort) are from patients with colon cancer diagnosed at Leiden University Medical Center, the Netherlands, from 2001 to 2015 that did not object for future use of human tissues for scientific research and that were…

Predicine is a global molecular insights company committed to advancing precision medicine in oncology and infectious disease diagnostics. Predicine is developing proprietary technologies for cell-free DNA and cell-free RNA liquid biopsy to enable minimally invasive molecular diagnoses for early cancer detection, treatment selection, therapy response, minimal residual disease monitoring, and…

Predicine is a global molecular insights company committed to advancing precision medicine in oncology and infectious disease diagnostics. Predicine is developing proprietary technologies for cell-free DNA and cell-free RNA liquid biopsy to enable minimally invasive molecular diagnoses for early cancer detection, treatment selection, therapy response, minimal residual disease monitoring, and…

69 11.05.2023 – 16:59 Invivoscribe, Inc. San Diego (ots/PRNewswire) SAN DIEGO, May 11, 2023 /PRNewswire/– “We are pleased to announce today that the LeukoStrat® CDx flt3 -Invivoscribe’s mutation test has been approved by BSI (Netherlands) and EMA as a Class C CDx test that meets the stringent new IVDR requirements…

SAN DIEGO, May 11, 2023 /PRNewswire/ — “Today we are pleased to announce that Invivoscribe’s LeukoStrat® CDx FLT3 Mutation Assay has been approved by BSI (Netherlands) and the EMA as a Class C CDx assay, meeting the stringent new IVDR (Regulation (EU) 2017/746) requirements. Invivoscribe is one of the first companies…

Doctors are increasingly using genetic signatures to diagnose diseases and determine the best course of care, but using DNA sequencing and other techniques to detect genomic rearrangements remains costly or limited in capabilities. However, an innovative breakthrough developed by researchers at Virginia Commonwealth University Massey Cancer Center and the VCU…

Codexis, Inc. CDX-7108 Clinical Development Program Remains on Track       Estimated Cash Runway Through End of 2024 Funds Important Upcoming Milestones Company Reiterates 2023 Total Revenue Guidance with Adjustments to Product vs. R&D Revenue Mix and Range on Gross Margin REDWOOD CITY, Calif., May 04, 2023 (GLOBE NEWSWIRE) —…

Tempus on Monday announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for its xT CDx sequencing test as a companion diagnostic. xT CDx is a 648-gene next-generation sequencing test (NGS) for solid tumor profiling, which includes microsatellite instability status and companion diagnostic claims for…

xT CDx is the company’s first Premarket Approval from the FDA CHICAGO, May 01, 2023–(BUSINESS WIRE)–Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s first Premarket Approval (PMA) application for its companion diagnostic test, xT CDx….

NEW YORK – Tempus said Monday that the US Food and Drug Administration has given premarket approval for the firm’s companion diagnostic test for colorectal cancer treatment. Chicago-based Tempus’ xT CDx is a 648-gene next-generation sequencing test that can be used to provide solid tumor profiling in cancer patients with…

The FDA has approved xT CDx, a 648-gene next-generation sequencing (NGS) assay for solid tumor profiling, and companion diagnostic for patients with colorectal cancer.1 The qualitative NGS-based in vitro diagnostic device is intended to be leveraged to identify substitutions like single nucleotide variants and multinucleotide variants and insertion and deletion…

DiaCarta, Ltd. Abstracts demonstrating XNA technology’s improvements to assay sensitivity across different technology platforms and support for use in companion diagnostics (CDx) assay development Additional abstracts to further support XNA technology’s potential for use in minimal residual disease (MRD) monitoring of residual cancer cells PLEASANTON, Calif., April 16, 2023 (GLOBE…

Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here. Moderna, Inc. (Nasdaq: MRNA) and Merck (NYSE: MRK) announced the first presentation of detailed results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination…

Genomic profiling of circulating tumor DNA (ctDNA) with a large panel appeared feasible in a routine setting and helped to obtain relevant molecular information that could inform strategies with targeted therapies for patients with metastatic solid tumors, according to findings from the prospective PRISM study published in Annals of Oncology….

The global carrier screening market is expected to record a CAGR of 12.4% between 2023 and 2033, with a size estimated in 2023 at US$ 1,343.40 million. The market’s value is expected to rise to US$ 4,323.84 million by 2033. As a result of increased funding from the public and commercial sectors…

Molecular profiling company Foundation Medicine on Tuesday announced a collaboration with Bristol Myers Squibbto develop the FoundationOne CDx test as a companion diagnostic to repotrectinib, Bristol Myers Squibb’s investigational tyrosine kinase inhibitor (TKI). Repotrectinib is currently being evaluated in a phases I and II study, TRIDENT-1, for patients with TKI-naïve…

NEW YORK – Foundation Medicine said Tuesday that it has expanded an ongoing collaboration with Bristol Myers Squibb to include companion diagnostic development for the pharma firm’s investigational tyrosine kinase inhibitor repotrectinib. Repotrectinib is an orally administered tyrosine kinase inhibitor that is being evaluated in an ongoing registrational Phase I/II…

BANGALORE, India, March 28, 2023 /PRNewswire/ — The Global Bioinformatics Market is Segmented by Technology & Services (Knowledge Management Tools, Bioinformatics Platforms, and Bioinformatics Services), Application (Metabolomics, Molecular Phylogenetics, Transcriptomics, Proteomics, Chemoinformatics, Genomics, and Others), and Sector (Medical Bioinformatics, Animal Bioinformatics, Agriculture Bioinformatics, Academics, and Others). The global bioinformatics market size…

NEW YORK – Incyte said on Monday that that the Japanese Ministry of Health, Labor, and Welfare approved Pemazyre (pemigatinib) for treatment of patients with myeloid or lymphoid neoplasms (MLNs) bearing FGFR1 fusions. The agency’s decision was based on the Phase II FIGHT-203 trial, in which Wilmington, Delaware-based Incyte established…

Knockdown of LFPRLR reduces splenic B-cell subsets in SLE-prone mice To investigate whether the PRL-LFPRLR axis raises the risk of initiation of B-cell malignancies, we compared SLE-prone MRL-lpr mice treated with either control SMO or LFPRLR SMO. Among SLE-prone models, we chose MRL-lpr mice because they accumulate genetic lesions indicative…

An upcoming phase 3 clinical trial will compare the safety and efficacy of Fablyn (lasofoxifene) plus Verzinio (abemaciclib) to the standard treatment of Faslodex (fulvestrant) plus Verzinio in pre- and post-menopausal patients with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation. The randomized multicenter study will enroll…

NEW YORK – A team from Genentech, Foundation Medicine, and elsewhere has come up with a machine learning model for bringing together a range of circulating tumor DNA (ctDNA) metrics to predict treatment response and related survival patterns in advanced lung cancer patients — an approach that is expected to…

The FDA has approved an expanded indication for Illuccix (TLX591-CDx), a kit that prepares for Ga-68 PSMA-11 PET injection, to allow for the selection of patients with metastatic prostate cancer who may benefit from prostate-specific membrane antigen (PSMA)–directed radioligand 177Lu-PSMA-617 (Pluvicto), according to a press release from Telix Pharmaceuticals.1 “[Illuccix]…

A phase 3 study has commenced which will compare targeted lasofoxifene in combination with the CDK 4/6 inhibitor abemaciclib vs fulvestrant (Faslodex) plus abemaciclib (Verzenio) in pre- and post-menopausal patients with locally advanced or metastatic estrogen receptor (ER)-positive/HER2-negative breast cancer with an ESR1 mutation, according to Sermonix Pharmaceuticals Inc. “The…

PRESS RELEASE Published March 13, 2023 DelveInsight’s, “Urothelial Carcinoma Pipeline Insight, 2023,” report provides comprehensive insights about 40+ companies and 50+ pipeline drugs in the Urothelial Carcinoma pipeline landscape. It covers the Urothelial Carcinoma pipeline drug profiles, including Urothelial Carcinoma clinical trials and nonclinical stage products. It also covers the…

Content sponsored by Blue Buffalo. Historically, physicians have identified cancer in humans and animals through the appearance of an obvious mass/lump or the development of clinical signs that typically occur when a tumor is advanced (weight loss, vomiting, coughing, etc). Over the past few decades, technologies have improved substantially to…

QIAGEN N.V.QGEN recently announced that it has entered into a strategic partnership with Servier. The agreement is intended to develop a companion diagnostic test for TIBSOVO — an isocitrate dehydrogenase-1 or IDH1 inhibitor indicated for treating the blood cancer acute myeloid leukemia or AML. For investors’ note, QIAGEN has master…

NEW YORK – Sermonix Pharmaceuticals is starting a Phase III trial of endocrine therapy lasofoxifene for patients with locally advanced or metastatic ER+/HER2-breast cancer with an estrogen receptor 1 (ESR1) mutation, the company said on Thursday. Sermonix has partnered with Guardant Health for the trial and will use the Guardant360…

Prospective screening of subjects for ESR1 mutations will use the Guardant360 CDx blood test for companion diagnostic development Phase 3 study is supported by previously presented ELAINE-1 and ELAINE-2 Phase 2 study results Sermonix anticipates dosing the first patient in first half of 2023 COLUMBUS, Ohio and PALO ALTO, Calif.,…

NEWARK, Del, March 08, 2023 (GLOBE NEWSWIRE) — The global carrier screening market is expected to record a CAGR of 12.4% between 2023 and 2033, with a size estimated in 2023 at US$ 1,343.40 million. The market’s value is expected to rise to US$ 4,323.84 million by 2033. As a…

NEW YORK – Illumina and Myriad Genetics said on Thursday that they have expanded their strategic partnership on homologous recombination deficiency (HRD) testing. Under the terms of the agreement, Illumina’s TruSight Oncology 500 HRD research-use-only assay will now be available in the US. Illumina will offer distributable kits while Myriad will…

NEW YORK – Foundation Medicine said on Thursday that its companion diagnostic comprehensive genomic profiling tests will be made available to certain cancer patients under Point32Health’s health plans through an expansion of coverage criteria. Under the value-based agreement, the FoundationOne CDx and FoundationOne Liquid CDx assays will be available to…

(UroToday.com) The 2023 GU ASCO annual meeting included an oral abstract session on renal cell carcinoma (RCC), featuring a presentation by Dr. Brian Shuch discussing results from ZIRCON, a phase 3 study of 89Zr-DFO-girentuximab for PET/CT imaging of clear cell RCC. The increasing detection of renal masses presents a significant patient…

Roche announced Thursday that it has expanded its collaboration with Janssen Biotech to develop companion diagnostics for targeted therapies. Roche said that the expanded agreement broadens opportunities for Roche and Janssen to collaborate in the precision medicine field with multiple companion diagnostics technologies, including immunohistochemistry (IHC), digital pathology, next generation…

What is the probability of having Phase 3 success, and is Phase 4 required? Stockhead reached out to Cynata’s CMO, Dr Jolanta Airey We look at ASX stocks with ongoing Phase 3 trials   In order to progress to the Phase 3 clinical trials, a drug must have demonstrated promising…

The global carrier screening market is expected to record a CAGR of 12.4% between 2023 and 2033, with a size estimated in 2023 at US$ 1,343.40 million. The market’s value is expected to rise to US$ 4,323.84 million by 2033. As a result of increased funding from the public and…

World Cancer Day offers a platform to raise the awareness of the latest advancements in oncology that are changing both the treatment of patients and the practice of clinicians around the world. In this regard, Next Generation Sequencing (NGS) continues to be at the forefront of precision medicine in oncology….

The Global Hemato Oncology Testing Market 2032 Industry Report is a professional and in-depth study on the current state of the Hemato Oncology Testing Market by QMI. The Hemato Oncology Testing Market is supposed to demonstrate a considerable growth during the forecast period of 2023-2032. The company profiles of all…

During the third quarter, SG Americas Securities LLC sold off 43.4% of its holdings in Myriad Genetics, Inc. (NASDAQ: MYGN) shares, as stated in the most recent SEC filing that the company submitted. The company now owns a total of 29,966 of the company’s shares of the stock following the…

Dear LabPulse.com reader, Abbott Chairman and CEO Robert Ford on Wednesday said he sees an easing of challenges affecting the company’s businesses at the start of 2023 and anticipates organic sales growth this year in the high single digits, excluding COVID-19 testing sales. The firm booked diagnostics segment revenues of…

Thermo Fisher Scientific announced on January 24 that it is working with AstraZeneca as part of a global, multiyear agreement to develop a solid tissue and blood-based companion diagnostic (CDx) test for the biopharma firm’s Tagrisso (osimertinib) non-small cell lung cancer (NSCLC) treatment. The test would identify patients with NSCLC…

NEW YORK – Foundation Medicine and Karyopharm Therapeutics said Tuesday they are collaborating on a companion diagnostic for Karyopharm’s experimental drug Xpovio (selinexor), which is in development as a maintenance therapy for patients with advanced or recurrent TP53 wild-type endometrial cancer. The partnership between the two Massachusetts-based firms will use…

NEW YORK – Helix and Qiagen have formed an exclusive global partnership to develop and commercialize companion diagnostics for hereditary diseases, the firms announced on Thursday. Financial terms of the partnership were not disclosed. The collaboration will address the health burden of hereditary neurodegenerative, cardiovascular, autoimmune, and inflammatory diseases, the…

DUBLIN–(BUSINESS WIRE)–The “Global KRAS Inhibitors Market & Clinical Trials Forecast 2028” report has been added to ResearchAndMarkets.com‘s offering. The advancement in clinical research has led to the identification of several oncogenes that are generally mutated in cancers. Kirsten rat sarcoma 2 viral oncogene homolog (KRAS) is the most frequently mutated…

Cholangiocarcinoma, or bile duct most cancers, is lethal even when caught early. The 5-year survival rate amongst these identified early is 17% to 25%; for many sufferers, the speed is under 10%. Experts say the important thing to bettering these dismal statistics is to give attention to the various genetic…

Myriad Genetics Precise Oncology Solutions  Myriad Genetics announced the launch of Precise Oncology Solutions, a new service through which oncologists can order its BRACAnalysis CDx and MyChoice CDx; its MyRisk Hereditary Cancer Test; and the Precise Tumor Molecular Profile Test, which is performed at a CLIA-certified lab operated by Intermountain…

– Fast Track Designation granted from U.S. Food and Drug Administration for PRA023 for the treatment of Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) – – New patent granted for PRA023 companion diagnostic (CDx) reinforces Prometheus’ precision approach and extends CDx patent coverage into 2040 – – Company to present today…

Introduction The use of drugs should be different among diverse ethnic groups because of differences in ethnicity, age, sex, environmental factors and genetic factors. If these differences are ignored, then drug sensitivity, metabolic rate, and adverse reactions are affected, which influences the curative effect of drugs and aggravates the illness…

Introduction Renal cell carcinoma (RCC) accounts for approximately 2–3% of all malignant tumors, and its prevalence is rising. Metastatic RCC accounts for 25–30% of all RCC cases, and has an exceedingly poor prognosis.1 In 2020, among approximately 430,000 newly discovered cases of RCC, 179,000 died.2 Clear cell renal cell carcinoma…

NEW YORK – Qiagen and Denovo Biopharma said on Thursday that they are collaborating to develop a blood-based companion diagnostic test to identify patients expressing a genomic biomarker who are likely to respond to Denovo’s investigational DB102 treatment for diffuse large B-cell lymphoma. Under the agreement, Qiagen will develop an…

News and research before you hear about it on CNBC and others. Claim your 1-week free trial to StreetInsider Premium here. QIAGEN (NYSE: QGEN) and Denovo Biopharma LLC today announced a collaboration to develop a blood-based companion diagnostic (CDx) test to identify patients expressing Denovo Genomic Marker 1 (DGM1TM) who…

Oncologists discuss a 59-year-old man with poorly differentiated adenocarcinoma of the lung. During a Targeted OncologyTM Case-Based Roundtable event, Mary Jo Fidler, MD, associate professor, Division of Hematology, Oncology, and Cell Therapy, Rush Medical College, discussed a 59-year-old man with non–small cell lung cancer. SHAH: I do next-generation sequencing [NGS]…

Company Description Company Description: Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs…

Precision oncology leverages molecular information about cancer to personalize therapy and improve outcomes. The discovery and development of relevant biomarkers is a prerequisite to fulfillment of the promise of precision oncology, but the challenge for researchers is that clinically actionable mutations occur at very low frequency and sourcing biospecimens with…

1. Ross JS, Wang K, Javle MM et al. Comprehensive genomic profiling of biliary tract cancers to reveal tumor-specific differences and frequency of clinically relevant genomic alterations. J Clin Oncol 2015;33:40009. doi.org/10.1200/jco.2015.33.15_suppl.4009. Article  Google Scholar  2. Goyal L, Govindan A, Sheth RA et al. Prognosis and clinicopathologic features of patients…

Published: Oct. 20, 2021 at 10:30 AM EDT|Updated: 8 hours ago — New Tool for Detection of Minimal Residual Disease in Acute Myeloid Leukemia to Better Help in Fight Against Cancer — BALTIMORE, Oct. 20, 2021 /PRNewswire/ — Sysmex Inostics has developed a new CLIA-validated liquid biopsy test for the…

1,000-patient prospective study in 11 solid tumors will monitor ctDNA levels up to five years Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, has initiated the Observation of ResiduAl Cancer with Liquid biopsy Evaluation (ORACLE) study, a 1,000-patient prospective, observational, multi-center study designed to evaluate the performance of…

Identifying biomarkers in metastatic breast cancer (MBC) has become an integral part of choosing treatments and understanding disease progression. The American Society of Clinical Oncology Clinical Practice Guideline, published in 2015, recommends an initial biopsy to confirm estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2…

Sponsored content brought to you by   The promise of precision oncology is being realized, with an array of targeted treatments and immunotherapies now available across a spectrum of cancer and other indications. Genomic insights have played a critical role in advancing our understanding of cancer biology and driving the…

Company DescriptionCompany Description: Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across…

NEW YORK – Chinese genomic testing firm Genetron Health said Monday that it has partnered with Impact Therapeutics to support the firm’s anti-cancer drug development efforts. The two companies plan to work together to discover new targets and develop companion diagnostics for a class of drugs called synthetic lethal inhibitors,…

NEW YORK – At the European Society for Medical Oncology Congress this week, precision oncology assay developer Lucence presented data that demonstrated its amplicon-based LiquidHallmark assay could be used to personalize care for people with advanced urothelial carcinoma. LiquidHallmark is a laboratory-developed test based on the company’s AmpliMark next-generation sequencing platform…

HAYWARD, Calif., Sept. 16, 2021 /PRNewswire-PRWeb/ — Predicine, Inc. announced today results from a liquid biopsy study demonstrating the clinical application of utilizing the PredicineCARE liquid biopsy NGS assay to serially monitor changes in ctDNA levels in patients with metastatic castration-resistant prostate cancer (mCRPC). The European Urology study evaluated the effects…

Next-Generation Sequencing Utilizing Tumor Tissue and/or Blood The identification of actionable genomic alterations in tumors such as mCRC was once performed by Sanger DNA sequencing of tumor DNA that was extracted from fixed paraffin-embedded tumor tissue, but this has now been replaced by next-generation sequencing (NGS), which allows for larger-scale…

NEW YORK – Molecular Health said Wednesday that is collaborating with South Korea’s Eone-Diagnomics Genome Center to create a combined offering for precision oncology testing. Specifically, the companies are pairing Molecular Health’s MH Guide software and EDGC’s OncoCatch-CDx assay, which analyzes circulating tumor DNA using next-generation sequencing in-house bioinformatics. A joint…

Note1 – Previous version: Produce PCA bi-plot for 1000 Genomes Phase III in VCF format (old) Note2 – this data is for hg19 / GRCh37 Note3 – GRCh38 data is available HERE The tutorial has been updated based on the 1000 Genomes Phase III imputed genotypes. The original tutorial was…

How to convert .mol files to cdx? 0 Now I have many .mol files, I want to convert them to .cdx files, cdx is a format of chemdraw, How can I do this programmatic, Thanks. convert mol cdx chemdraw • 13 views Source link