Highlights & Summary
Liquid Biopsy (LBx) continues to be of relevance now and in the future, with more clinical trial updates and launches taking place every month, as well as with new LBx approvals worldwide.
Clinical Adoption & Commercialization
1 | Invitae Launches its First CE-IVD Cancer Testing Kits In Europe
CE-IVD Approval | Invitae
FDA BDD | Foundation Medicine
3 | GRAIL and Point32Health Collaborate to Offer Galleri® Multi-Cancer Early Detection Blood Test
Clinical Adoption | GRAIL, Point32Health
Company Announcements & Product Launches
Commercial Collaboration | Foundation Medicine, Eli Lilly
2 | HealthBiocare GmbH conducted pioneering research for non-invasive detection of cancer
Novel Assay | HealthBiocare GmbH, System Biologie AG, University of Vienna
Product Launch | C2i Genomics, Twist Bioscience
Clinical Trials & Study Results
Clinical Trial Update | Guangzhou Burning Rock Dx Co., Ltd., Shanghai Zhongshan Hospital
Study Results | Inivata, LMU Klinikum, LMU Munich
Clinical Trial Launch | Tempus Labs
M&A | VC | Private Equity | Legal
Funding | BioFluidica
2 | The Mark Foundation plans to spend $500 million on cutting-edge cancer research
Grant Announcement | The Mark Foundation
Clinical Adoption & Commercialization
1 | Invitae Launches its First CE-IVD Cancer Testing Kits In Europe
CE-IVD Approval | Invitae
Invitae’s Anchored Multiplex PCR (AMP) chemistry, including FusionPlex Dx and LiquidPlex Dx, is now available in Europe as a CE-marked IVD test. These panels allow comprehensive genomic profiling (CGP) and companion diagnostic (CDx) use for solid tumors and are intended to be used on Illumina’s NGS platforms for IVD testing. LiquidPlex Dx identifies mutations in ctDNA isolated from plasma and covers 29 genes. LiquidPlex Dx also is intended for use as a CDx to identify NSCLC patients with METex14 skipping alterations for treatment with targeted therapy.
FDA BDD | Foundation Medicine
The Food and Drug Administration (FDA) granted Foundation Medicine, Inc. a Breakthrough Device Designation (BDD) for the use of their FoundationOne®Tracker in molecular residual disease (MRD) surveillance of relapse following curative therapy for early-stage cancers. The FoundationOne®Tracker was developed in partnership with Natera and combines their specialties in CGP and circulating tumor-DNA (ctDNA) monitoring from Foundation and Natera respectively to provide molecular patient therapy response assessments, MRD surveillance, and the detection of relapse following curative intent therapy. The designation follows Foundation’s promising presentation on MRD in metastatic colorectal patients with surgical resection at the ASCO Gastrointestinal Cancer Symposium and comes in anticipation of their ASCO Genitourinary Cancers Symposium presentation on early-stage bladder cancer MRD.
3 | GRAIL and Point32Health Collaborate to Offer Galleri® Multi-Cancer Early Detection Blood Test
Clinical Adoption | GRAIL, Point32Health
GRAIL and Point32Health are collaborating for a pilot study of Galleri, Grail's early-detection, multi-cancer blood test. The Galleri test can detect more than 50 types of cancer, 45 of which lack recommended screening tests. Currently, 70% of cancer deaths are from cancers that lack early detection screening. Point32Health, which consists of Harvard Pilgrim Health Care and Tufts Health plan, is the first commercial health plan in the US to work with GRAIL on Galleri. The Galleri test will be first offered to Point32Health employees who meet specific criteria, such as a family history of cancer. From there, the test will be offered to Point32Health commercial members. This second phase will allow for the gathering of real-world data to assess if access to the test can improve patient outcomes.
Additional Sources
Clinical Collaboration | Personalis, UC San Diego Moores Cancer Center
5 | Pathogenomix granted FDA Breakthrough Device Designation
De Novo Authorization | Pathogenomix
Company Announcements & Product Launches
Commercial Collaboration | Foundation Medicine, Eli Lilly
Foundation Medicine (FMI) announced a collaboration with Eli Lilly and Company (Lilly) for the development of FMI's tissue and blood based assays as companion diagnostics (CDx) for therapies offered by Lilly. The partnership will first be highly focused on RETEVMO, Lilly's FDA approved RET inhibitor for patients with NSCLC or certain types of thyroid cancers. The partnership will investigate how FoundationOne CDx for adult patients with RET fusions could be eligible for RETEVMO both in the US and in the EU.
2 | HealthBiocare GmbH conducted pioneering research for non-invasive detection of cancer
Novel Assay | HealthBiocare GmbH, System Biologie AG, University of Vienna
Collaborators at HealthBiocare GmbH, System Biologie AG, and the University of Vienna developed a novel multiomic LBx assay based on genetic and epigenetic markers to classify diseased and healthy patients across nine cancer types (lung, pancreas, colorectal cancer (CRC), prostate, ovarian, breast, stomach, bladder, and brain cancer). Some features of the assay include an accuracy of 95.4%, sensitivity of 97.9%, and specificity of 80%. The classification model analyzes cfDNA mutations, microRNAs (miRNAs), and cfDNA methylation markers in patient plasma samples. The companies plan to further validate the test’s clinical utility and determine its ability to assess tissue of origin (TOO) through a larger prospective cohort.
Product Launch | C2i Genomics, Twist Bioscience
C2i Genomics and Twist Bioscience Corporation have entered a partnership to create whole-genome cancer reference materials. The collection will give diagnostic labs a better ability to validate and monitor the quality of their MRD and cancer screening products. C2i will use AI to identify variants across the whole genome that are associated with cancer signatures, then Twist will synthesize each of these variants to create a WGS-focused set of reference materials. It is expected that the reference standards will be useful for Twist's liquid biopsy assays, complementing their already released cfDNA Pan-Cancer Reference Standards.
Additional Sources
1 | BioCaptiva Advancing Cell-Free DNA Isolation Device to Boost Liquid Biopsy Sensitivity
Product Launch | BioCaptiva
2 | QIMR Berghofer Partners With Liquid Biopsy Startup Biopsomic on Cancer Test
Research Collaboration | QIMR Berghofer Medical Research Institute, Biopsomic
Commercial Collaboration | BioTechne, Thermo Fisher Scientific
Clinical Trials & Study Results
Clinical Trial Update | Guangzhou Burning Rock Dx Co., Ltd., Shanghai Zhongshan Hospital
ASCEND-Gastric is a new multi-omics observational study using liquid biopsy to detect gastric cancer. The study combines assays for serum protein markers, deep sequencing of cfDNA, ctDNA mutation and circulating RNA, with an estimated enrollment of 498 participants. Primary outcome measure for the trial is determining sensitivity and specificity of the cfDNA methylation-based model in detecting gastric cancer.
Study Results | Inivata, LMU Klinikum, LMU Munich
Inivata published promising clinical validation data for their RaDaRTM LBx test on head and neck squamous cell carcinoma (HSNCC) from their prospective clinical study, Liquid BIOpsy for MiNimal RESidual DiSease Detection in Head and Neck Squamous Cell Carcinoma (LIONESS), done through a collaboration with the Department of Otorhinolaryngology, Head and Neck Surgery (ORL-HNS), LMU Klinikum, and the Institute of Pathology, Faculty of Medicine, LMU Munich. Blood samples were collected from 17 patients with stage III-IVB, p16-negative HNSCC who received curative-intent primary surgical treatment, then assessed for ctDNA to detect MRD and recurrence pre- and post-surgery. RaDaRTM demonstrated 100% clinical detection of ctDNA pre-surgery, ctDNA levels as low as 0.0006% variant allele frequency (VAF), 100% sensitivity in patients with recurrence, 100% specificity in patients without recurrence, and lead times ahead of clinical confirmation ranging from 108 to 253 days.
Clinical Trial Launch | Tempus Labs
Beginning in February of this year, 338 patients with NSCLC will be enrolled in a study to determine efficacy of surveillance using Tempus NSCLC NGS assays. There will be two cohorts studied: patients with stages I-IIIA cancer eligible for surgery and patients with stages IIIB-IV who are not eligible for surgery. Over the course of the two year study, recurrent-free survival and progression-free survival statistics will be gathered. The study will ultimately shed light on how effective monitoring via NGS assays can be towards patient outcomes.
Additional Sources
Clinical Trial Launch | Freenome
2 | Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion
Clinical Trial Launch | Mirati Therapeutics Inc.
3 | Invitae Launches Study to Generate Real-World Data on Personalized MRD Test Across Tumor Types
Study Launch | Invitae
4 | DiviTum(R)TKa Results from PYTHIA Published in EJC
Clinical Trial Update | International Breast Cancer Study Group (IBSCG), Breast International Group (BIG), Pfizer
Study Results | Clinical Genomics, Flinders Medical Center
Validation Study Results | Natera
7 | Cell-Free DNA Assay Shows Promise for Detecting Stem Cell Transplant Complications
Proof-of-Concept (POC) Study | Cornell University
M&A | VC | Private Equity | Legal
Funding | BioFluidica
BioFluidica has raised over $6 million in its Series B2 financing, led primarily by BioFluidica’s existing investor base. The funding will allow BioFluidica to expand commercialization of LiquidScan, its liquid biopsy platform that scans CTCs, cfDNA, and/or exosomes as point-of-care testing in hospitals, CLIA labs, and research institutes.
2 | The Mark Foundation plans to spend $500 million on cutting-edge cancer research
Grant Announcement | The Mark Foundation
The Mark Foundation for Cancer Research announced a commitment of $500 million in funding for cutting-edge cancer research through grants and investments in primarily translational-stage technology companies. The foundation has already awarded over 200 grants totalling $150 million to researchers in over 80 academic institutions globally. The Mark Foundation believes LBx is a potentially transformative technology for cancer early detection (EDx) and has a track record of investing in and awarding grants to LBx companies such as GRAIL during their Series B and a grant to C2i Genomics for clinical data generation.
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