Liquid Biopsy | September Roundup

October 6, 2022
Newsletter Update
Clinical Diagnostics

Highlights & Summary

Liquid Biopsy (LBx) continued to develop through September, featuring ample product launches and clinical trial publications spurred on by ESMO conferences. 

Featured DeciBio Insights

1 | Mark a Course for the Future – Biomarkers in Cancer Immunotherapy

 Oncology Biomarkers Landscape | Andrew Aijian, Colin Enderlein

2 | Oncologist Perspectives on the Most Exciting Advancements in Precision Medicine

 Oncologist Survey | Colin Enderlein


Clinical & Regulatory

Headlining September’s limited regulatory advances is SeekIn as they received a CE marking for their OncoSeek multi-cancer early detection (MCED) test. OncoSeek analyzes the plasma levels of seven protein tumor markers (PTMs). The company founded in China has restated its commitment to seeking Chinese regulatory approvals in addition to its efforts in the EU.

1 | SeekIn Receives CE Mark Approval for OncoSeek® Multi-Cancer Detection Test CE Approval | SeekIn


Company Announcements & Product Launches

Major company announcements in September surrounded novel assay launches and innovative research and commercial partnerships. Delfi Diagnostics was selected as the liquid lung cancer biopsy partner in Europe's multi-national, randomized, prospective lung cancer screening trial known as 4-IN-THE-LUNG-RUN (4ITLR). Guardant Health announced a novel assay, Guardant Infinity, for a more comprehensive molecular profile of tumors with genotyping coverage of more than 800 genes with sample-level methylation detection and tumor fraction score. Angle PLC announced that an assay developed using the Parsortix System could predict malignancy in pelvic masses; this study will go on to aid efforts to create an LDT for detecting ovarian cancer.

1 | Delfi Diagnostics Selected as the Liquid Biopsy Partner for 4-IN-THE-LUNG-RUN: A Large-Scale European Lung Cancer Screening Study EU Research Collaboration | Delfi Diagnostics, Netherlands Cancer Institute, Institute for DiagNostic Accuracy

2 | Guardant Health Introduces GuardantINFINITY™ Smart Liquid Biopsy for Research Use to Help Bring New Cancer Therapies to Patients Sooner Novel Assay Announcement | Guardant Health

3 | Angle PLC Announces Novel Assay; Predicts Malignancy in Pelvic Mass Novel Assay Announcement | Angle PLC


Clinical Trials & Study Results

GRAIL presented updated data from its PATHFINDER study, finding the test to have a positive predictive value of 43.1% and a specificity of 99.5%. Freenome announced the launch of the Sanderson Study, which is a study of Freenome’s multiomics platform with real-world data and machine learning algorithms for cancer early detection. The study plans to enroll about 8,000 patients across the United States. Bio-Techne presented initial data on a non-invasive saliva profiling assay for Sjogren’s syndrome diagnosis and monitoring, leveraging extracellular vesicles (EVs) in a small saliva sample to monitor the RNA transcriptome. Companies such as NeoGenomics’ Inivata and Predicine also presented data on their liquid biopsy tests at ESMO, and Molecular Stethoscope published a study in mice using their proprietary cell-free mRNA liquid biopsy test.

1 | GRAIL Announces Final Results From the PATHFINDER Multi-Cancer Early Detection Screening Study at ESMO Congress 2022 Validation Results (NCT04241796) | GRAIL

2 | Freenome Launches Study of Multiple Cancers Pairing Multiomics with Real-World Data  Study Launch | Freenome, Learning Health Network


M&A | VC | Private Equity | Legal 

Due to concerns over hurting competition, an EU veto of Illumina’s acquisition pushes for Illumina to divest GRAIL, which Illumina is planning to challenge. Naveris announced a $33.4 million expansion of its Series A financing to advance commercialization of NavDx, its flagship blood test for early detection of cancers caused by human papillomavirus (HPV), and generate clinical data to expand its use. Swiss biotech startup Hedera Dx raised around $13.6 million in seed funding for their goal to use liquid biopsy to enable hospital labs to run clinically actionable tests in-house to improve therapy selection for cancer patients. AOA Dx has also closed a $7 million funding round that will be used to help develop a liquid biopsy test to detect early stage ovarian cancer and to hire more employees.

1 | Illumina will have to divest Grail after EU blocks takeover Divesture | Illumina, GRAIL

2 | Naveris, Inc. Raises $51 Million to Advance Commercialization of NavDx | Business Wire Series A Funding | Naveris, Gurnet Point Capital

3 | Swiss biotech startup Hedera Dx raises €14 million in its mission to improve cancer treatment options Funding | Hedera Dx 

Additional Sources


Company Announcements & Product Launches

4 | Caris Life Sciences and Flatiron Health Partner to Vastly Increase Access to Most Comprehensive Molecular Testing Available  Commercial Partnership | Caris Life Sciences, Flatiron Health

Clinical Trials & Study Results

4 |  Molecular Stethoscope's cf-mRNA liquid biopsy machine learning platform used in a mouse model of inflammation and pharmacologic intervention study published in eBiomedicine Study Results | Molecular Stethoscope

5 | NeoGenomics and Liquid Biopsy Subsidiary Inivata and Collaborators to Present New Data at ESMO Congress 2022 ESMO Conference Abstracts | NeoGenomics, Inivata

6 | Predicine to Present New Data at ESMO 2022 Demonstrating the Utility of its Portfolio of Liquid Biopsy Tests for Cancer Patients ESMO Study Presentations | Predicine

7 | Florida Cancer Specialists & Research Institute Physicians Present Cancer Care Advancements at Global Oncology Gathering ESMO Study Presentations | Florida Cancer Specialists & Research Institute

8 | Angle PLC Announces New Poster Presented at ASCP Meeting - September 13, 2022 Validation Results | Angle PLC

9 | Angle PLC Announces Notice of Interim Results and Webcast - Sep 01, 2022 Interim Study Results | Angle PLC

M&A | VC | Private Equity | Legal

4 | AOA Dx Closes $7M Funding Round to Commercialize First Accurate Early Detection Test for Ovarian Cancer   Seed Funding | AOA Dx, Avestria Ventures

5 | Florida Lab Owner Charged in $53 Million Health Care Fraud and Kickback Scheme Related to Genetic Cancer Screening Tests | USAO-NJ | Department of Justice Fraud | U.S. DOJ

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