CAPP-Seq

Foresight Diagnostics’ PhasED-Seq Circulating Tumor DNA Platform Demonstrates Highly Sensitive Minimal Residual Disease (MRD) Detection in B-Cell Lymphomas

Retrieved on: 
Thursday, July 22, 2021

AURORA, Colo., July 22, 2021 (GLOBE NEWSWIRE) -- Foresight Diagnostics today announced publication of studies demonstrating unprecedented analytical and clinical sensitivity of the Companys proprietary circulating tumor DNA (ctDNA) detection platform for minimal residual disease (MRD) detection in B-cell lymphomas.

Key Points: 
  • AURORA, Colo., July 22, 2021 (GLOBE NEWSWIRE) -- Foresight Diagnostics today announced publication of studies demonstrating unprecedented analytical and clinical sensitivity of the Companys proprietary circulating tumor DNA (ctDNA) detection platform for minimal residual disease (MRD) detection in B-cell lymphomas.
  • Physicians have recently begun using circulating tumor DNA (ctDNA) as a minimally invasive liquid biopsy approach to characterize cancers, particularly in the metastatic setting.
  • Superior MRD detection during treatment: PhasED-Seq was compared to SNV-based ctDNA detection in 88 DLBCL patients after 2 cycles of immuno-chemotherapy.
  • Accurate and rapid detection of residual disease at the completion of therapy presents a meaningful opportunity to intervene and improve outcomes.

New Publication Shows 96% Overall Survival Among Metastatic Colorectal Cancer Patients Who Test MRD-Negative with Signatera® After Surgery

Retrieved on: 
Thursday, July 22, 2021

It isalso Natera's first major publication in CRC to prospectively assess overall survival in MRD-positive and negative patients, setting an important new standard for test performance and evidence quality.

Key Points: 
  • It isalso Natera's first major publication in CRC to prospectively assess overall survival in MRD-positive and negative patients, setting an important new standard for test performance and evidence quality.
  • Serial testing improved Signatera sensitivity to 91%, among patients who did not receive adjuvant treatment, with 100% overall survival among those who remained serially MRD-negative.
  • Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer.
  • Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers.

Foresight Diagnostics to Present a Vision of the New Standard of Lymphoma MRD Detection at the 16th International Conference on Malignant Lymphoma

Retrieved on: 
Thursday, June 17, 2021

The oral presentation demonstrates the utility of Foresight Diagnostics proprietary PhasED-Seq technology to improve MRD detection rates in DLBCL patients in low-disease burden settings.

Key Points: 
  • The oral presentation demonstrates the utility of Foresight Diagnostics proprietary PhasED-Seq technology to improve MRD detection rates in DLBCL patients in low-disease burden settings.
  • We believe that such early detection constitutes the future standard for ctDNA-guided patient monitoring and treatment in the clinic and for drug development applications.
  • Circulating tumor DNA (ctDNA) detection has prognostic value in DLBCL and has the potential to change the management of lymphoma in the clinic.
  • But detection is still challenging in low-disease burden states with existing methods, such as MRD detection at the end of therapy.

FDA Grants Two New Breakthrough Device Designations for Natera's Signatera™ MRD Test

Retrieved on: 
Wednesday, March 24, 2021

These new designations will support the development of Signatera through Phase III clinical trials as a companion diagnostic to two different cancer therapies.

Key Points: 
  • These new designations will support the development of Signatera through Phase III clinical trials as a companion diagnostic to two different cancer therapies.
  • "These two new Breakthrough Device Designations will help us accelerate our mission to bring life-saving diagnosis and treatment to cancer patients as early as possible."
  • Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer.
  • The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications.

Biomark's Collaborator Receives Funding to Validate Its Biomarker Panel for the Early Detection of Lung Cancer

Retrieved on: 
Tuesday, March 16, 2021

The funding application is entitled "A novel rapid, liquid biopsy early-stage lung cancer diagnostic test".

Key Points: 
  • The funding application is entitled "A novel rapid, liquid biopsy early-stage lung cancer diagnostic test".
  • The funding will be used to validate BioMark's liquid biopsy platform and proprietary biomarker panel for the detection of early-stage lung cancer in over 1200 patients.
  • A simpler, cheaper and more accurate test for early detection of lung cancer would benefit patients by providing improved outcome to high-risk patients.
  • BioMark is developing proprietary, non-invasive, and accurate cancer diagnostic solutions which can help detect, monitor, and assess treatment for cancer early and cost-effectively.

Spectrum Solutions Collaborates with UCLA on Saliva-Based Next-Gen Sequencing (NGS) Liquid Biopsy Research for the Early Detection of Lung Cancer

Retrieved on: 
Wednesday, January 27, 2021

Spectrum Solutions, LLC today announced its sponsored research collaboration with the UCLA School of Dentistry for a study on using saliva in early lung cancer detection and analysis.

Key Points: 
  • Spectrum Solutions, LLC today announced its sponsored research collaboration with the UCLA School of Dentistry for a study on using saliva in early lung cancer detection and analysis.
  • Spectrum has funded a study that aims to recruit 50 patients with lung cancer and seeks to validate salivas tumor-specific ctDNA detection sensitivity and positive agreement against tissue biopsy-based genotyping.
  • Saliva will be collected, preserved, and transported for DNA testing using Spectrums Saliva Collection System.
  • Spectrum Solutions is a single-source provider of on-site medical device development and manufacturing, custom packaging, kitting, and direct-to-consumer fulfillment.

New Signatera™ Data to be Presented at the 2020 ESMO IO Congress from the Phase III IMvigor010 Trial

Retrieved on: 
Wednesday, December 9, 2020

The study also shows that ctDNA clearance was higher in the treatment arm vs. the observation arm (p=0.0048).

Key Points: 
  • The study also shows that ctDNA clearance was higher in the treatment arm vs. the observation arm (p=0.0048).
  • "This opens new avenues for patient selection in the future and is an important step in the drive towards personalized cancer therapy."
  • "This randomized Phase III study demonstrates for the first time, unequivocally, that Signatera can identify which patients are likely to benefit from adjuvant therapy and which are unlikely to benefit.
  • Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers.

Natera Presents New Data at the 2020 SITC Annual Meeting Highlighting Applications of Personalized ctDNA Testing in Immunotherapy Treatment Monitoring

Retrieved on: 
Tuesday, November 10, 2020

Natera will present four posters demonstrating the ability of Signatera to monitor response to immunotherapy in colorectal and breast cancer.

Key Points: 
  • Natera will present four posters demonstrating the ability of Signatera to monitor response to immunotherapy in colorectal and breast cancer.
  • "I am excited to partner with Natera to further explore early indications of treatment response, or lack thereof, using this novel technology."
  • ctDNA levels were corroborated by imaging in all cases and predicted tumor responses weeks ahead of imaging, supporting the use of ctDNA as a dynamic biomarker for response to immunotherapy.
  • These data highlight a potential use of ctDNA-based MRD testing to help inform "watch & wait" approaches.

Study Shows Biocept's Target Selector™ May Provide a More Robust Method for Detecting Lung Cancer Metastasis in Cerebrospinal Fluid than Cytology

Retrieved on: 
Monday, October 5, 2020

In this study, 28 cerebrospinal fluid samples from 15 patients obtained sequentially before and during treatment were compared.

Key Points: 
  • In this study, 28 cerebrospinal fluid samples from 15 patients obtained sequentially before and during treatment were compared.
  • Target Selector improved detection of circulating tumor cells (CTC), finding CTCs in 78% of the samples, whereas cytology detected tumor cells in 55% of samples.
  • Target Selector also provided sensitive quantitative identification of actionable EGFR mutations in cerebrospinal fluid.
  • The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies.

Clinical Genomics Announces Publication of Additional Clinical Data for COLVERA® Recurrence monitoring Blood Test for Colorectal Cancer Patients

Retrieved on: 
Tuesday, September 22, 2020

This U.S. population study further reinforces the performance of COLVERA, the breakthrough blood test for the clinical presence of CRC recurrence in patients amenable to curative intent.

Key Points: 
  • This U.S. population study further reinforces the performance of COLVERA, the breakthrough blood test for the clinical presence of CRC recurrence in patients amenable to curative intent.
  • COLVERA therefore represents an important advance over the current standard of care for colorectal cancer surveillance.
  • Clinical Genomics products span the full spectrum of colorectal cancer testing from screening to post-treatment monitoring.
  • COLVERA is the first of its kind blood test to detect circulating tumor DNA for minimal residual disease (MRD) assessment and recurrence monitoring in patients previously diagnosed with colorectal cancer.