Liquid Biopsy | September Roundup

October 6, 2022

Newsletter Update

Clinical Diagnostics

Alex Amram

Senior Analyst

Hannah Glazier

Senior Associate

Amal Thommil

Senior Associate

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Highlights & Summary

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

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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

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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

3 | BIO-TECHNE PRESENTS INITIAL DATA ON SJÖGREN'S SYNDROME MONITORING ASSAY Study Results | Bio-Techne

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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

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