Highlights & Summary
Liquid Biopsy (LBx) companies push forward on clinical trial inclusion for greater real world validation, cancer indication expansion for existing assays, and regulatory approval in the US and Europe.
Clinical Adoption & Commercialization
Regulatory Approval | NeoGenomics, Inivata
Clinical Adoption | GRAIL, Knight Cancer Institute
LDT Launch | Epic Sciences
Company Announcements & Product Launches
1 | Early brain cancer detection: A game-changing new blood test
Product Announcement | DxCover
2 | Illumina collaborates with National Cancer Center Japan to address a leading cause of death in Asia
Collaboration | Illumina
3 | PetDx and IDEXX Expand Access to OncoK9, the Cancer Liquid Biopsy Test for Dogs
New Service Offering | IDEXX, PetDx
Clinical Trials & Study Results
1 | Study Shows Natera’s Signatera MRD Test Predictive of Chemotherapy Benefit in Colorectal Cancer
Clinical Trial Results | Natera
Clinical Trial Launch | Natera Inc., Novartis Pharmaceuticals, NSABP Foundation Inc
3 | Freenome Presents Research Highlighting its Multiomics Blood Testing Platform in PREEMPT CRC
Study Launch | Freenome
M&A | VC | Private Equity | Legal
1 | Freenome surpasses $1B in total funding with major investment from Roche
Funding | Freenome
2 | Nucleix Announces Recent Advancements in Early Lung Cancer Detection Program
Funding / Clinical Trial Results | Nucleix
3 | JPM 2022: Exact Sciences Moves Into Hereditary Cancer Tests with $190M PreventionGenetics Buyout
Acquisition | Exact Sciences, PreventionGenetics
Clinical Adoption & Commercialization
Regulatory Approval | NeoGenomics, Inivata
NeoGenomics announced that its liquid (LBx) focused subsidiary, Inivata, received a CE mark for its RaDaR assay. RaDaR detects molecular residual disease (MRD) and recurrence, consisting of 48 tumor specific variants. Validation studies on the assay showed 95% sensitivity and 100% specificity for ctDNA at concentration levels as low as 0.0011% VAF. The CE mark is important for use in both the EU and the UK. Inivata has additionally applied to the MolDX program for reimbursement in clinical testing in the US.
Clinical Adoption | GRAIL, Knight Cancer Institute
GRAIL, LLC announced a collaboration with the Knight Cancer Institute at Oregon Health & Science University (OHSU) to offer Galleri®, GRAIL’s multi-cancer early detection (MCED) blood test. Starting this month, OHSU patients will have access to Galleri through a pilot program. The partnership follows GRAIL’s successful completion of a clinical study showing a false positive rate of less than 1% in 50 cancer types. OHSU is also a leading partner in GRAIL’s PATHFINDER 2 study for real world evaluation of Galleri® MCED.
LDT Launch | Epic Sciences
Epic Sciences announced plans to launch an early-access program in April in the US for DefineMBC, an LBx that combines analyses of circulating tumor cells (CTCs), single-cell whole-genome sequencing, and cell-free DNA (cfDNA) sequencing into a single assay to comprehensively profile metastatic breast cancer. The lab-developed test (LDT) uses immunofluorescent staining and machine learning image analysis to identify CTCs and quantify protein expression, while using NGS via an Illumina platform to analyze cfDNA. The clinical gene panel includes 56 genes, while an extended panel of up to 500 genes is utilized in research and clinical trials.
Company Announcements & Product Launches
1 | Early brain cancer detection: A game-changing new blood test
Product Announcement | DxCover
The first ever spectroscopic liquid biopsy test for brain cancer, the Dxcover® Brain Cancer Liquid Biopsy test, combines Attenuated Total Reflection Fourier Transform Infrared (ATR-FTIR) Spectroscopy with machine learning (ML) algorithms to analyze the whole molecular composition of blood samples. The technology spun out of DxCover’s CTO Dr. Matthew J. Baker’s lab was created in part through collaborations with Sepac, an ATR-accessories provider, and clinicians to address the shortcomings of low abundance cancerous genetic material in early-stage brain tumors further depleted by the blood-brain barrier. DxCover completed two clinical studies where the Dxcover® Brain Cancer Liquid Biopsy test discriminated between patients with brain tumor diagnoses and asymptomatic controls, identifying gliomas as small as 0.2 cm. DxCover is set on expanding the technology into a multi-cancer assay as well as pursuing CE, In Vitro Diagnostic Regulation (IVDR), and FDA regulatory approvals.
2 | Illumina collaborates with National Cancer Center Japan to address a leading cause of death in Asia
Collaboration | Illumina
Illumina and the National Cancer Center Japan are launching an international joint research project A-TRAIN: the Asian Multicenter Prospective Study of Circulating Tumor DNA Sequencing. The study focuses on nasopharyngeal carcinoma, a rare cancer indication with 80% of global disease occurrences in Asia and 67% in Southeast Asia. A-TRAIN will implement Illumina's TruSight™ Oncology (TSO) 500 on up to 96 patients. TSO 500 is a Research Use Only (RUO) comprehensive pan-cancer assay that utilizes tumor sample DNA and RNA to identify 523 tumor biomarkers such as gene variants and fusions. The study will also research cancers of different origins such as cervical, ovarian, and breast cancers. The project will create a database through examining genomic alterations collected with liquid biopsies. The study will be conducted as part of a greater international collaboration — the Asian clinical TriaLs network for cAncerS (ATLAS) project.
3 | PetDx and IDEXX Expand Access to OncoK9, the Cancer Liquid Biopsy Test for Dogs
New Service Offering | IDEXX, PetDx
PetDx, an LBx company built for the treatment of cancer in pets, is collaborating with IDEXX laboratories to broaden access to canine cancer testing. OncoK9, the original LBx test offered by PetDx, will be available to all veterinary customers by the end of spring 2022. By using NGS technology, OncoK9 can help better diagnose, treat, and monitor canine cancers. Plus, recent studies show that the test’s specificity and sensitivity is on par with cancer screening methods for human patients.
Additional Sources
4 | Natera Announces Expansion Into Early Cancer Detection and Screening
Prognostic Expansion | Natera
5 | Grail Partners With Premier's PINC AI to Improve Patient Access to Blood-Based Multi-Cancer Test
Partnership | Grail, PINC AI
6 | C2i Genomics, OncoDNA Enter Strategic Alliance for AI-Based Cancer Detection, Monitoring
Partnership | C2i Genomics, OncoDNA
7 | Protein-Based Liquid Biopsy Panel Assesses Tumor Microenvironment, Shows Prognostic Potential
Proof-of-Principle Study | Leiden University Medical Center (LUMC)
Progress Update | BIOCAPTIVA
Clinical Trials & Study Results
1 | Study Shows Natera’s Signatera MRD Test Predictive of Chemotherapy Benefit in Colorectal Cancer
Clinical Trial Results | Natera
The landmark CIRCULATE-Japan study suggests Natera's Signatera MRD test is predictive of chemotherapy (CT) benefit in colorectal cancer (CRC). Patients who were MRD-positive at 4 weeks post-op showed significant benefits from adjuvant CT (ACT) across all stages of disease unlike MRD-negative patients. Signatera dynamics during ACT also were found to help predict treatment benefit, with 68% of ACT-treated patients cumulatively clearing their ctDNA by week 24 and having significantly better outcomes relative to ctDNA-positive counterparts (hazard ratio of 15.8).
Clinical Trial Launch | Natera Inc., Novartis Pharmaceuticals, NSABP Foundation Inc
Collaborators Novartis Pharmaceuticals and Natera Inc. and their sponsor, the NSABP Foundation Inc, posted plans for a 31 participant interventional clinical trial projected to start in March 2022. The trial will study the recurrence-free survival of microsatellite-stable (MSS) colon cancer in patients that are circulating tumor DNA (ctDNA) positive and treated with gevokizumab. As part of the intervention/treatment, Natera’s Signatera diagnostic test will conduct intermittent ctDNA monitoring at weeks 8, 12, 24, 36, 48, 60 and 72 unless disease recurrence is documented. The secondary outcomes measured by Signatera mainly involve the clearance of ctDNA, the percentage of patients who convert to a negative ctDNA assay at 8 weeks from study start, as well as the duration of recurrence free survival (RFS) with ctDNA clearance. Signatera’s inclusion as a primary clinical trial intervention diagnostic test accounting for trial primary outcomes is a crucial step in establishing liquid biopsy’s (LBx) clinical utility with real world data and applications.
3 | Freenome Presents Research Highlighting its Multiomics Blood Testing Platform in PREEMPT CRC
Study Launch | Freenome
At the American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI), Freenome presented on the development of their multiomics blood test to detect colorectal cancer (CRC) and plans to finish recruitment for PREEMPT CRC. PREEMPT CRC is the largest prospective study (> 25,000 participants) for a noninvasive test for CRC screening in an average-risk population. The multiomics approach analyzes tumor and healthy cell signals from DNA and proteins. In a prior prospective, multi-center study, the platform’s sensitivity and specificity were shown to be both 94%. With a third of average-risk individuals over the age of 50 not complying with testing recommendations, Freenome hopes to increase testing rates for CRC in this population.
Additional Sources
4 | Angle PLC Announces Concordance of Parsortix with tissue biopsy
Study Results | Angle PLC
Study Results | Bluestar Genomics
6 | CareDx Prepares KidneyCare for Commercial Launch With CLIA Validation, Clinical Studies
Study Results | CareDx
7 | Angle PLC Announces Insight into Drug Resistance in NSCLC
Study Results | Angle PLC
Study Results | Oncocyte
Pilot Study Results | Sysmex Inostics
M&A | VC | Private Equity | Legal
1 | Freenome surpasses $1B in total funding with major investment from Roche
Funding | Freenome
Freenome announced that Roche has made an investment of $290 million, bringing Freenome's total funding to more than $1.1 billion since 2014. This funding will help accelerate Freenome's machine learning-enabled multiomics blood test for CRC screening, which is being clinically validated in PREEMPT CRC, a large, prospective clinical trial in the final stages of enrollment. Freenome is also seeking to expand its multiomics blood test into novel biomarkers and cancer indications with a recent presentation on pancreatic cancer detection data.
2 | Nucleix Announces Recent Advancements in Early Lung Cancer Detection Program
Funding / Clinical Trial Results | Nucleix
Nucleix announced recent developments in the potential impacts of its Lung EpiCheck next-generation sequencing (NGS) platform for early-stage lung cancer detection (also compatible with polymerase chain reaction (PCR) platforms). EpiCheck analyzes the methylation changes of multiple biomarkers to monitor and detect lung cancer development early on. In a recent study, conventional bisulfite approaches detected a mere 1% of markers that EpiCheck detected in early stage lung cancer patients. Nucleix also recently launched a prospective, multi-center clinical study aiming to enroll approximately 5,000 patients. Aside from studies, Nucleix raised an additional $22 million in funding, bringing their total capital raised in 2021 to $77 million.
3 | JPM 2022: Exact Sciences Moves Into Hereditary Cancer Tests with $190M PreventionGenetics Buyout
Acquisition | Exact Sciences, PreventionGenetics
Exact Sciences closed a deal for a $190 million acquisition split 50-50 in cash and stock for PreventionGenetics, which offers more than 5,000 DNA tests mainly focused on the hereditary risks of cancer. Recently, Exact Sciences also licensed OncXerna Therapeutic’s tumor microenvironment panel for immunotherapy patient stratification. Exact Sciences will include the panel in their GEM ExTra tumor sequencing test offering with future plans to develop the panel into a companion diagnostic.
Additional Sources
4 | In Ongoing False Advertising Suit, Judge Allows Natera Counterclaims Against Guardant Health
Legal Affairs | Natera, Guardant Health
5 | Personalis Signs Deal With BTIG for $100M At-Market Stock Offering
Stock Offering | Personalis
6 | Biodesix Raises Approximately $16.3M in Sale of Common Shares, Amends $30M Term Loan
Stock Sale | Biodesix
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