Liquid Biopsy | July Roundup

Highlights & Summary

July showcased new partnerships, product launches, clinical trials, and study result updates in liquid biopsy.

Company Announcements & Product Launches

This month, Mercy partnered with GRAIL to offer GRAIL’s Galleri test to detect more than 50 types of cancer, and GRAIL and NHS completed enrollment of 140,000 participants in the largest study of a multi-cancer early detection (MCED) test. BillionToOne launched their first liquid biopsy products Northstar Select and Northstar Response. Northstar Select is a pan-cancer panel utilizing BillionToONe’s molecular counting technology, while Northstar Response is a ctDNA methylation-based monitoring assay. BillionToOne is further validating these tests through a partnership with University of California, San Diego to access cancer patient samples. In other news, HaloDiagnostics teamed up with IncellDx to improve diagnostic care for urogenital cancer patients. GuardantHealth partnered with AdiconHoldingsLimited to conduct clinical trials with Guardant Health’s comprehensive genomic profiling (CGP) tests. This will offer greater access to diagnostics for cancer populations in China. MiRXES Ptr Ltd also announced the launch of Project CADENCE (Cancer Detected Early caN be CurEd), the world’s first large-scale clinical research project for the discovery and validation of panels of blood-based circulating miRNA and DNA methylation biomarkers, to develop a multi-cancer early detection (MCED) test.

1 | Mercy Offers New GRAIL Blood Test to Detect 50+ Types of Cancer Clinical Offering Partnership | Mercy, GRAIL

2 | BillionToOne launches oncology liquid biopsy products for research use & announces clinical research collaboration with UCSD Product Launch | BillionToOne

3 | HALO Diagnostics, IncellDx Partner to Advance Novel Testing, Improve Standard of Care for Prostate and Bladder Cancers?Partnership| HALO Diagnostics, IncellDx

Clinical & Regulatory

ESMO ctDNA assay-use recommendations endorsing liquid biopsy as a standard of care for genotyping and treatment selection in patients with advanced cancer. While tissue-based testing remains priority, ESMO’s Precision Medicine Working Group detailed ctDNA assays may be preferred in instances where results are delivered faster or where tissue biopsies are not possible. July brought approvals in other regards as well with Aniling receiving a CE-IVD mark for three tests one of which is a liquid biopsy test, GEUS-LB, which aims to improve patient diagnosis. PamGene’s melanoma LBx test has also been registered as CE-IVD. PamGene’s IOpener melanoma test aims to improve physician’s treatment decisions for melanoma patients. This month also marked movements towards increased coverage with Adaptive Biotechnologies receiving expanded medicare coverage for their MRD Lymphoma test clonoSEQ. The test is specifically designed for diffuse large B-cell lymphoma (DLBCL) and uses ctDNA measurements to help oncologists increase their understanding of how likely a patient is to have recurrence. This coverage is significant as a majority of patients with DLBCL are in the medicare age range.

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1 | ESMO Releases Guidelines for Liquid Biopsy Testing in Cancer Patients | Precision Oncology News?Guidelines | ESMO

2 | Aniling Gets CE-IVD Marks for Cancer Sequencing Tests CE-IVD Approval | Aniling

3 | Adaptive Biotechnologies Receives Expanded Medicare Coverage of clonoSEQ? for Monitoring Minimal Residual Disease in Diffuse Large B-Cell Lymphoma Medicare Expansion | Adaptive Biotechnologies, Palmetto GBA

Clinical Trials & Study Results

July showcased new clinical trial results, validation studies, and clinical trial launches. Geneseeq’s early cancer detection research program DECIPHER (Detecting Early Cancer by Inspecting ctDNA features) produced promising results this month with their early detection assay yielding 95.5% sensitivity at 95% specificity. Lucence presented study results of their ultrasensitive amplicon-based liquid biopsy technology, AmpliMark, at the 2022 World Conference on Lung Cancer (WCLC). Singlera Genomics is collaborating with Chinese Academy of Medical Sciences Cancer Institute to explore the predictive effect of plasma ctDNA methylation status in colorectal cancer patients. Other trial launches include Novartis’s evaluation of biomarkers in advanced HR+/HER2- breast cancer patients, Fudan University and BGI Tianjin’s assessment of ctDNA dynamics in advanced epithelial ovarian cancer patients, and Novosanis and Universiteit Antwerpen’s analysis of analytes in urine with Colli-Pee?. A validation study from Guangdong Lung Cancer Institute maintained the potential of ctDNA testing to determine recurrence possibility in early stage lung cancer patients.

1 | Geneseeq Early Cancer Detection Program Publishes High-Performance Results?Clinical Trial Results | Geneseeq

2 | Lucence Presents Data at 2022 World Conference on Lung Cancer (WCLC) Supporting Utility of Amplicon-Based Liquid Biopsy Validation Study Data | Lucence?

3 | Application of Polygenic Methylation Markers in Postoperative Recurrence Monitoring of Colorectal Cancer Clinical Trial Launch | Singlera Genomics, Chinese Academy of Medical Sciences Cancer Institute

M&A | VC | Private Equity | Legal?

This month, Delfi Diagnostics raised $225 Million in Series B Financing to continue their development of fragmentomics-based liquid biopsy tests for cancer detection and treatment monitoring. Acuamark Diagnostics raised $11.3 Million in Series A financing for the development of their early cancer detection liquid biopsy tests, which use a PCR-based multiplexing technology. 4D Lifetec also raised $1.9 Million in Series B funding to support the launch of their lung cancer detection test. Outside of funding, major headlines surrounded European antitrust regulators’ continued investigation of the purchase of Grail by Illumina. This case is key in maintaining the European Commission’s ability to examine the dynamics in large company acquisition deals.

1 | Delfi Diagnostics Announces $225 Million Series B Financing to Develop Globally Accessible Portfolio of Liquid Biopsy Tests Series B Financing | Delfi Diagnostics, DFJ Growth

2 | Acuamark Diagnostics Raises $11.3M to Support Cancer Detection Test Development Series A Financing | Accumark Diagnostics, Claudio Del Vecchio, Bruker

3 | EU regulators can examine Illumina, Grail deal, EU court says Trust Law | Illumina, Grail?

Additional Sources

Company Announcements & Product Launches

4 | World’s first research project for an early detection, multi-cancer screening test launched in Singapore Product Development Partnership | MirXes, NUS Medicine, National Cancer Center Singapore

5 | GRAIL and National Health Service (NHS) England Complete Enrollment of 140,000 Participants in Largest Study of Multi-Cancer Early Detection Test Study Enrollment | GRAIL, National Health Service (NHS) England

6 | Guardant Health and Adicon announce strategic partnership to offer comprehensive genomic profiling tests to accelerate development of new cancer therapies in China Partnership | Guardant Health, Adicon

7 | MGI Tech, Burning Rock Biotech Join Forces to Develop Precision Oncology Products Product Development Partnership | Burning Rock, MGI Tech

8 | Lifespin Significantly Expands its Proprietary Database of Human Health Profiles in Oncology Under Newly Established Cooperative Scientific Agreement with the Medical University of Graz Research Collaboration | Lifespin GmbH, Biobank Graz

9 | Guardant Health Licenses Genomic Cancer Assays to Adicon for Testing in China International Licensing Deal | Guardant Health, Adicon

10 | Imagia Canexia Health and Anwa Medical Company Enter Memorandum of Understanding to Bring Liquid Biopsy to Middle East and North Africa (MENA) Offering Geographical Expansion | Imagia Canexia Health, Anwa Medical Co.

Clinical & Regulatory

4 | Bio-Techne Announces Launch of the CE-IVD RNAscope? ISH Probe High Risk HPV Assay For Head and Neck Cancer CE-IVD Approval | Bio-Techne

5 | PamGene attains IVDD registration for its IOpener?-melanoma immunotherapy guidance test in Europe CE-IVDR Approval | PamGene

6 | Caris Life Sciences Announces Enhanced Epic Partnership to Vastly Improve Access to Most Comprehensive Molecular Testing Available Clinical Offering Partnership | Caris Life Sciences, Epic

7 | Stakeholders Urge Collaboration to Prove ctDNA as Regulatory Endpoint for Early Cancer Drugs FDA Draft Guidance | FDA, Friends of Cancer Research

Clinical Trials & Study Results

4 | Non-invasive Identification of Colorectal Cancer and Adenomas in Early Stages (NICE)

Clinical Trial Launch | Venn Biosciences Corporation

5 | Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients (CAPTOR-BC) Clinical Trial Launch | Novartis Pharmaceuticals, Institut fuer Frauengesundheit

6 | Lung Cancer MRD Study Bolsters Validity Evidence, Suggests Longitudinal Test Cutoff Validation Study Data | Guangdong Lung Cancer Institute

7 | Bespoke ctDNA Assay for Recurrence and Treatment Response Monitoring in Advanced Epithelial Ovarian Cancer (EOC) Clinical Trial Launch | Fudan University, BGI Tianjin

8 | Evaluation Protocols for Isolation of Analytes From Urine for Future Oncology Applications (URODETECT-WP1) Clinical Trial Launch | Novosanis, Universiteit Antwerpen

M&A | VC | Private Equity | Legal

4 | 4D Lifetec Raises $1.9M in Series B Financing to Support Lung Cancer Detection Test Launch Series B Financing | 4D Lifetec