Highlights & Summary
Liquid Biopsy (LBx) continued to develop through January, featuring new product launches, collaborations, and trial launches and study results.
Clinical and Regulatory
Guardant Health gained Medicare coverage for its Guardant Reveal test in the CRC surveillance setting after curative intent treatment, representing an expansion from the prior Medicare coverage only in the early post-surgical setting in CRC. ctDNA monitoring has also been included in NCCN guidelines for Merkel Cell Carcinoma for surveillance, based on data from Natera’s Signatera.
1 | Guardant Health Gains Medicare Coverage for Colorectal Cancer Monitoring Test Medicare Coverage | Guardant Health
2 | ctDNA Monitoring Included in NCCN Guidelines for Merkel Cell Carcinoma Recurrence Surveillance Guidelines Inclusion | Natera
Company Announcements & Product Launches
Natera announced new products at JPM, introducing a new version of Signatera leveraging a WGS baseline (offered in addition to the traditional WES version) and announcing a tissue-free MRD assay utilizing methylation, expected to launch in mid-2025 in CRC initially. This announcement also came with first performance data for their methylation-based early cancer detection assay, demonstrating 92% detection of stage I CRC and 95% detection overall, at a specificity level of 91%. Myriad Genetics announced a five-year strategic alliance with MD Anderson Cancer Center to accelerate the clinical evaluation and development of Myriad’s MRD assay. The collaboration will focus on studies in breast, gastrointestinal, genitourinary, and gynecological cancers. Datar Cancer Genetics also announced the launch of Target-MRD, an MRD assay that combines tumor-agnostic NGS with a customized, tumor-informed ddPCR assay.
1 | Natera Announces Innovation Roadmap, with Advancements in MRD and Early Cancer Detection Product Launches | Natera
2 | MD Anderson and Myriad Genetics Form Strategic Alliance to Evaluate Clinical Utility of Myriad’s Molecular Residual Disease Assay Partnership | MD Anderson, Myriad Genetics
3 | Datar Cancer Genetics Introduces Revolutionary Tumor-Agnostic + Informed Blood Test for Residual Disease Monitoring Product Launch | Datar Cancer Genetics
Clinical Trials & Study Results
Natera announced new data from the Phase III CALGB (Alliance) / SWOG 80702 study, which evaluated whether Signatera-positive stage III CRC patients benefitted from an escalation in adjuvant treatment. Key findings included Signatera-positivity after surgery being predictive of DFS and OS benefit with the addition of celecoxib to adjuvant FOLFOX and Signatera status after surgery and prior to starting adjuvant therapy being highly predictive of recurrence. Personalis, in collaboration with Professor Charles Swanton and colleagues at London’s Francis Crick Institute and University College London, also published new results from their TRACERx lung cancer study. The NeXT Personal MRD test showed 100% sensitivity for non-adenocarcinomas and 81% for lung adenocarcinomas in the cohort of 171 early-stage NSCLC patients, and showed ctDNA levels prior to surgery were highly prognostic for overall survival in early-stage LUAD patients. Additionally, patients who tested positive for low traces of cancer (below 80 PPM of ctDNA) still had a high risk of recurrence. Exact Sciences also shared clinical validation data for its OncoDetect MRD test from the Alpha-CORRECT study, showing 78% sensitivity at the post-surgical timepoint and 91% sensitivity during the surveillance period, with specificities of 80% and 94% respectively. The study primarily included patients with stage III colon cancer. The NCI selected the Avantect Multi-Cancer Detection Test by ClearNote Health and the SHIELD Multi-Cancer Detection Test by Guardant Health to be included in the Vanguard Study on multi-cancer detection which will be conducted by the Cancer Screening Research Network.
1 | Natera Announces Successful Readout of Randomized, Phase III CALGB (Alliance)/SWOG 80702 Clinical Trial in Colorectal Cancer Trial Results | Natera
2 | New Nature Medicine Publication Shows ctDNA Levels Linked to Recurrence Risk in Lung Cancer Study Results | Personalis
3 | NCI Selects Two Assays for the Vanguard Study on Multi-Cancer Detection Tests Study Inclusion | NCI, ClearNote Health, Guardant Health
M&A | VC | Private Equity | Legal
Enea TECH and Biomedical Foundation announced a €15 million investment in Tethis S.p.A., a Milan-based company. Tethis’ solutions include the See.d blood sample preparation instrument, SmartBioSurface slides treated with biocompatible nanomaterials that can isolate and capture cells in blood, and AI algorithms for identifying cellular elements of tumor origin. Oxford Cancer Analytics (OXcan) has also announced $11M in Series A funding for the development of its protein-based liquid biopsy tests for early cancer detection. Lung cancer is OXcan's primary focus.
1 | Enea TECH and Biomedical Foundation Invests €15M in Tethis to Develop New Diagnostic Method sin Oncology Using Liquid Biopsy Fundraising | Tethis
2 | OXcan (Oxford Cancer Analytics) Raises $11M to Develop Liquid Biopsy Tests for Early Cancer Detection Fundraising | Oxford Cancer Analytics
Additional Sources
Company Announcements & Product Launches
1 | Guardant Health, ConcertAI Collaborate to Form First Data-As-A-Service That Integrates Clinical and Tumor Profiling Data to Accelerate Cancer Therapy Research and Development Partnership | Guardant Health, ConcertAI
Clinical Trials & Study Results
1 | New Evidence Validates Oncodetect’s™ Ability to Detect Molecular Residual Disease and Predict Recurrence in Colorectal Cancer Patients Clinical Validation Data | Exact Sciences
2 | SeekIn Publishes a Cost-Effective Two-Step Approach for Multi-Cancer Early Detection Publication Publication | SeekIn
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