Highlights & Summary

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Liquid Biopsy (LBx) continued to develop through September, featuring new research collaborations as well as study results.

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Featured DeciBio Insights

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1 | Cell Therapy R&D and Manufacturing Market Report Market Report | DeciBio

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Clinical & Regulatory

The Japanese Ministry of Health, Labour, and Welfare (MHLW) approved the Guardant360 CDx liquid biopsy test as a companion diagnostic for ENHERTU for patients with advanced HER2+ NSCLC or for patients with recurrent HER2+ NSCLC. Daiichi Sankyo created ENHERTU as a HER2-directed antibody drug conjugate. 

1 | Guardant Health Receives Regulatory Approval in Japan for Guardant360® CDx as Companion Diagnostic to ENHERTU® for Treatment of Non-Small Cell Lung Cancer Patients with HER2 Mutations | Business Wire  Regulatory Approval | Guardant Health

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Company Announcements & Product Launches

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Memorial Sloan Kettering Cancer Center and Myriad Genetics are collaborating on a study that uses Myriad’s minimal residual disease testing platform to help predict therapy efficacy in metastatic breast cancer patients treated with CDK4/5 inhibitors or chemotherapy. Myriad utilizes whole-genome sequencing for their platform as a differentiator of test accuracy. Biological Dynamics and the Pancreatic Cancer Early Detection (PRECEDE) Consortium entered a research partnership this month as well. In the ExoLuminate study, Biological Dynamics’ ExoVita Pancrea Assay is used to identify early pancreatic ductal adenocarcinoma in high-risk individuals. In North America, Wren Labs is busy expanding the reach of their NETest neuroendocrine tumor diagnostic assay and its companion NETest PPQ test that informs therapy selection. Wren Labs recently signed a distribution agreement with Kindstar Globalgene Technology to support distribution in China and Southeast Asia, and they are currently in discussions to find a distributor in Japan. 

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1 | Myriad Genetics, Memorial Sloan Kettering collaborate on MRD testing for breast cancer Research Partnership | Myriad Genetics, Memorial Sloan Kettering

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2 | Wren Labs Launches Neuroendocrine Tumor Liquid Biopsy in Asia, Works on Expanding Testing Menu Product Launch | Wren Labs

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3 | Biological Dynamics and PRECEDE partner for pancreatic cancer surveillance  Research Partnership | Biological Dynamics, PRECEDE Consortium

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Clinical Trials & Study Results

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Natera announced use of its personalized, tumor-informed minimal residual disease (MRD) test, Signatera, in a new study within the I-SPY 2 trial. This prospective trial will monitor response to neoadjuvant therapy in 600 breast cancer patients (across all subtypes) as well as assess post-surgical ctDNA status. Lucence announced interim results for LIQUIK, a prospective international multicenter liquid biopsy study for lung cancer, showing that concordance of its LiquidHALLMARK® ctDNA liquid biopsy with tissue-based profiling across 9 NCCN guideline-recommended biomarkers ranged from 93.1% to 100%. Invitae also published analytical validation data for their Personalized Cancer Monitoring (PCM) assay, used for MRD and monitoring. Results showed the limit of detection ranged from 0.008% allele frequency when utilizing 60 ng of cfDNA input with 18–50 variants in the patient-specific panels (> 99.9% sensitivity) with a baseline threshold, to 0.05% allele frequency when using 10 ng of cfDNA input with an 18-variant panel with a monitoring threshold (> 99.9% sensitivity).

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1 | Natera announces Signatera test use in new I-SPY 2 trial Clinical Trial | Natera

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2 | Interim Results from LIQUIK Prospective Study Released at WCLC 2023 Interim Study Results | Lucence

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3 | Personalized Cancer Monitoring Assay for the Detection of ctDNA in Patients with Solid Tumors Analytical Validation Data | Invitae

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M&A | VC | Private Equity | Legal

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Agilent announced it is selling Resolution Bioscience, its cancer testing business, to Exact Sciences. Exact mentions that Resolution’s liquid therapy selection platform complements Exact’s OncoExTra test, aiding in determining treatment options. Harbinger Health closed a $140M series B fundraising round which will be used to support completion of CORE-HH, a 10,000 participant study for Harbinger’s multi-cancer early detection (MCED) test. Enrollment for CORE-HH is expected to complete in 2024. Adela has also raised $48M to advance their portfolio, including its tumor-agnostic minimal residual disease (MRD) monitoring product and its MCED test, both of which leverage Adela’s genome-wide methylome enrichment platform that acquires genomic information for maximizing test performance and enhancing treatment decisions. 

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1| Agilent to sell Resolution Bioscience to Exact Sciences Acquisition | Resolution Bio, Exact Sciences

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2 | Harbinger’s $140M fundraising bodes well for massive study of its MCED test Series B Financing | Harbinger Health

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3 | Adela receives $48m for MRD monitoring product portfolio advancement Financing | Adela

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Additional Sources

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Company Announcements & Product Launches

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1 | EDGC unlocking methylation patterns for early screening of multi-cancers with a drop of blood  MCED Product Launch | Eone-Diagnomics Genome Center (EDGC)

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2 | Biocept Signs CNSide™ Licensing Agreement with Plus Therapeutics Non-Exclusive Licensing Agreement | Biocept, Plus Therapeutics

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3 | Circular Genomics Announces Partnership on Alzheimer’s Disease Biomarker Research  Research Partnership | Circular Genomics, Washington University

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Clinical Trials & Study Results

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1 | Hong Kong Team Makes Progress in Cell-Free DNA for Early Diagnosis of Preeclampsia Study Results | University of Hong Kong

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‍2 | A protein panel in cerebrospinal fluid for diagnostic and predictive assessment of Alzheimer’s disease CNS LBx panel | Emory University, National Institute on Aging