Highlights & Summary
Liquid Biopsy (LBx) continued to develop through August, featuring new product launches and partnerships as well as study results.
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Clinical and Regulatory
Quest Diagnostics announced the company’s Haystack MRD test received FDA Breakthrough Device Designation for identifying MRD-positive patients with stage II CRC who may benefit from adjuvant therapy after surgery. Haystack MRD is a tumor-informed assay utilizing whole-exome sequencing for its baseline. The National Cancer Institute (NCI) shared its framework for selecting the multi-cancer early detection assays (Guardant’s SHIELD and ClearNote’s Avantect) used in the Vanguard pilot study. This framework included initial criteria such as the number of cancers a test was able to detect, a test’s stated specificity and sensitivity, and the strength of the studies supporting the test, followed by an evaluation phase in which NCI sent sample sets to each test provider and evaluated the results. NCI reviewers also considered readiness to participate in Vanguard and willingness to self-fund the cost of performing assays run within Vanguard.
1 | FDA Grants Breakthrough Device Designation for Haystack MRD Circulating Tumor DNA Test from Quest Diagnostics FDA BDD | Quest Diagnostics
2 | Framework to Select Multi-Cancer Detection Assays in the National Cancer Institute's Vanguard Study NCI Selection Framework | NCI
Company Announcements & Product Launches
Freenome announced an exclusive license agreement with Exact Sciences for Freenome’s CRC blood-based screening test, including the U.S. commercial rights and underlying technology. Freenome retains the rights for its CRC blood test when ordered in combination with additional cancer screening tests. ANGLE announced a collaboration with Myriad Genetics to assess whether circulating tumor cell (CTC) DNA harvested from blood samples using ANGLE’s Parsortix system can be used along with Myriad’s tissue-based assays. NeoGenomics announced the launch of NEO PanTracer LBx, a blood-based comprehensive genomic profiling (CGP) test designed to support therapy selection, trial matching, and longitudinal monitoring.
1 | Freenome Announces Exclusive License Agreement with Exact Sciences to Commercialize Freenome’s Blood-Based Screening Test for Colorectal Cancer Exclusive License Agreement | Freenome, Exact Sciences
2 | ANGLE partners with Myriad Genetics to explore blood-based cancer testing Collaboration | Myriad Genetics, Angle
3 | NeoGenomics Launches PanTracer LBx, Expanding Access to Comprehensive Genomic Profiling with Liquid Biopsy Product Launch | NeoGenomics
Clinical Trials & Study Results
Natera announced positive topline results from IMvigor011, with statistically significant and clinically meaningful improvement in disease-free survival (DFS) and overall survival (OS) for Signatera-positive patients treated with Tecentriq (atezolizumab). IMvigor011 is a phase III trial using Signatera to predict adjuvant immunotherapy benefit in muscle-invasive bladder cancer patients. Natera’s Signatera MRD assay has also been chosen as a pre-specified secondary endpoint in the Phase III ARCHER trial, which is testing shorter-course radiation therapy for muscle-invasive bladder cancer. Conducted across 100+ sites in the US and Canada, the study will use Signatera to track ctDNA clearance as a predictor of treatment response and recurrence, with urine tumor DNA also evaluated as an exploratory endpoint. Foresight Diagnostics published a landmark pooled analysis demonstrating Foresight’s CLARITY MRD test provided greater prognostic accuracy than PET/CT at the end of therapy in large B-cell lymphoma (LBCL).
1 | IMvigor011 Bladder Cancer Trial Achieves Positive Results, with Signatera™ Strongly Predicting Adjuvant Immunotherapy Benefit Trial Readout | Natera, Genentech
2 | Foresight Diagnostics Announces Publication of Landmark Study Demonstrating Prognostic Value of Ultrasensitive ctDNA-MRD Detection in Large B-Cell Lymphoma Study Data | Foresight Diagnostics
3 | Signatera™ Test Selected for NRG-Sponsored Phase III ARCHER Trial in Bladder Cancer Trial Activation | Natera
M&A | VC | Private Equity | Legal
A U.S. District Court stated that it will dismiss Natera’s claims against NeoGenomics and enter declaratory judgment of invalidity of both of Natera’s asserted patents, allowing NeoGenomics to broadly commercialize the RaDaR ST assay (previously RaDaR 1.1). Foresight Diagnostics announced it has entered into a limited licensing agreement with Roche related to Foresight’s patented PhasED-Seq technology, closing the litigation between the parties with all claims dismissed with prejudice. Under the terms of the agreement, Foresight has granted Roche a limited royalty-bearing non-exclusive sublicense under certain patents for use of PhasED-Seq for development of IVD kits for Non-Hodgkin’s Lymphoma (NHL).
1 | Court Rules for NeoGenomics in Patent Infringement Lawsuit Against Natera Patent Litigation| NeoGenomics, Natera
2 | Foresight Diagnostics and Roche Enter Licensing Agreement for PhasED-Seq™ Technology in Non-Hodgkin’s Lymphoma Licensing Agreement | Foresight Diagnostics, Roche
Additional Sources
Company Announcements & Product Launches
1 | Dana-Farber Cancer Institute, Boston Children’s Hospital, and Broad Clinical Labs launch precision genomics initiative for pediatric cancer Program Launch | Boston Children’s Hospital, Dana-Farber Cancer Institute, Broad Clinical Labs
2 | American Cancer Society and Guardant Health Partner to Expand Cancer Screening Access and Advance Health Equity Partnership | American Cancer Society, Guardant Health
3 | UCLA partners with Dongwoon Anatech to advance saliva-based diagnostic technology Partnership | UCLA, Dongwoon Anatech
