Liquid Biopsy | January Roundup 2024

February 9, 2024
Newsletter Update
Clinical Diagnostics

Highlights & Summary

2024 ushered in a lot of Liquid Biopsy (LBx) news, especially within MRD! January brought several collaborations, new study results, and legal decisions.

Clinical and Regulatory

In guidelines updated in late January, NCCN identifies ctDNA as an emerging colon cancer prognostic marker but cites insufficient evidence to recommend routine use outside of clinical trials, and does not recommend de-escalation of care based on ctDNA results. The language around the role of LBx in the NCCN guidelines for NSCLC and breast cancer were also updated, supporting “complementary testing [tissue and LBx] to reduce turnaround time and increase yield of targetable alteration detection” in NSCLC, and considering reflexing to the other [tissue or blood] if one specimen is negative for actionable biomarkers in breast cancer.

1 | NCCN Calls ctDNA Emerging Colon Cancer Prognostic Marker, Does Not Back Use Outside Clinical Trials Regulatory Announcement | NCCN

Company Announcements & Product Launches

Allogene Therapeutics and Foresight Diagnostics announced a partnership to use Foresight’s ctDNA-based PhasED-Seq in the ALPHA3 trial to stratify large B-cell lymphoma patients who are MRD-positive after 1L treatment for consolidation therapy. This consolidation therapy will be Allogene’s cema-cel, an off-the-shelf allogeneic CAR-T therapy. Predicine announced a collaboration with Janssen to develop PredicineCARE, a urine-based cfDNA NGS assay, as a companion diagnostic for targeted therapy. Illumina also expanded its collaboration with Janssen to advance its WGS MRD assay development. Tempus adds to MRD news with the introduction of xM, a ctDNA MRD assay that is currently RUO and for early-stage CRC patients. Personalis also partnered to distribute ClearNote Health’s 5hmc epigenomic platform within Personalis’ pharmaceutical service offerings. 

1 | Allogene Therapeutics, Foresight Diagnostics Partner to Develop MRD Test for CAR T-Cell Therapy Trial MRD Partnership | Allogene Therapeutics, Foresight Diagnostics

2 | Predicine Announces Collaboration with Janssen to Develop PredicineCARE™ as a Companion Diagnostic Assay in Localized Bladder Cancer CDx Collaboration | Predicine, Janssen

3 | Illumina expands collaboration with Janssen to advance molecular residual disease cancer test MRD Collaboration | Illumina, Janssen

Clinical Trials & Study Results

Haystack Oncology and Alliance Foundation Trials (AFT) announced a collaboration to use Haystack’s MRD test to analyze therapeutic response and provide molecular insights for AFT’s phase II clinical trial (AFT-57) in patients with unresectable stage III non-small cell lung cancer (NSCLC). The study will assess efficacy and safety of anti-PD-L1 atezolizumab with or without tiragolumab (anti-TIGIT) in conjunction with chemoradiotherapy. At ASCO GI, investigators presented the first official report of final Phase II data from Guardant Health’s COBRA trial assessing Guardant Reveal, a tumor-agnostic MRD assay, in early-stage CRC patients. The study assumed chemotherapy administration should have led to ctDNA clearance in most patients, but only one of the treated individuals cleared their ctDNA while three untreated control subjects did, leading to the trial being closed. Researchers from Novelna also published a study introducing a proteome-based liquid biopsy multi-cancer early detection (MCED) assay.

1 | Haystack Oncology and Alliance Foundation Trials collaborate to use Haystack MRD™ technology in phase II clinical trial for unresectable stage III NSCLC Trial Announcement | Haystack Oncology

2 | Trial Failure Raises Questions About MRD Testing Utility, but Prognostic Evidence Remains Strong Trial Results | Guardant

3 | Novel blood test shows promise in detecting early-stage cancers with high accuracy Study Results | Novelna, Olink

M&A | VC | Private Equity | Legal

Veracyte has announced the acquisition of C2i Genomics, Inc., an MRD company, for $70M at closing and up to an additional $25M based on future performance. This will add whole-genome MRD capabilities to Veracyte’s diagnostics platform, enabling it to continue expanding its offerings in the cancer care continuum. Burning Rock Biotech Limited, a precision oncology NGS company, announced it has received written notification from NASDAQ that its bid price was below the minimum requirement of $1.00 per share. Burning Rock will now have 180 days to regain compliance with the minimum bid requirement. Burning Rock’s business operations have not been affected by the NASDAQ letter. Natera has offered Invitae $52.5M to acquire its reproductive health screening tests. Invitae has accepted, and has already been paid $10M, with $42.5M to follow. Natera’s reproductive health portfolio includes genetic tests offering noninvasive prenatal screening and carrier screening. In other news, Circular Genomics, a company developing a circular RNA biomarker platform that predicts a patient’s sensitivity to antidepressants, has closed an $8.3M Series A investment round led by Mountain Group Partners.

1 | Veracyte Announces Preliminary Full-Year 2023 Results, Acquisition of C2i Genomics to Add Minimal Residual Disease Capabilities to Its Novel Diagnostics Platform Acquisition | Veracyte, C2i Genomics

2 | Burning Rock Announces Receipt of Notification from NASDAQ Delisting Warning | Burning Rock

3 | Natera offers $52.5M for Invitae’s reproductive health screening tests after patent spat Asset Acquisition | Natera

Additional Sources

Company Announcements & Product Launches

1 | Tempus Introduces xM to Assess Minimal Residual Disease (MRD) in Patients with Colorectal Cancer (CRC) for Research Use Only Product Announcement | Tempus

2 | Personalis and ClearNote Health Announce Partnership to Advance Epigenomic Technology Partnership Announcement | Personalis

3 | GRAIL Introduces State-of-the-Art Methylation-Based Solution to Accelerate Cancer Research in the Post-Diagnosis Setting Product Launch | Grail

4 | Hikma and Guardant Health sign exclusive partnership agreement to bring transformative cancer diagnostic technology to the Middle East and North Africa NGS Partnership | Guardant Health

5 | SOPHiA GENETICS Highlights Near-Term Growth Strategy at 42nd Annual J.P. Morgan Healthcare Conference Strategy Announcement | SOPHiA GENETICS

6 | City of Hope, TGen develop new approach for early cancer detection Tool Announcement | City of Hope

Clinical Trials & Study Results

1 | Targeted Epigenetic-Based Early Cancer Assay Detects Aggressive Prostate Cancer Study Results | Dana-Farber Cancer Institute, University of Trento

2 | Concurrent Tissue and Circulating Tumor DNA Molecular Profiling to Detect Guideline-Based Targeted Mutations in a Multicancer Cohort Study Results | JAMA Network Open

M&A | VC | Private Equity | Legal

1 | Local Startup Circular Genomics Closes $8.3M Investment Round Series A Fundraising | Circular Genomics

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