Highlights & Summary

Liquid Biopsy (LBx) continued to develop through November, featuring new clinical and research collaborations as well as trial launches and study results.

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Featured DeciBio Insights

1 | Exploring the Frontier of Multiomics: DeciBio Q&A with Peter Fromen, CEO of biomodal Q&A | DeciBio

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Company Announcements & Product Launches

Personalis and Tempus announced a collaboration to co-commercialize Personalis’ NeXT Personal Dx, a whole-genome based LDT for MRD and monitoring. The test will be offered in lung cancer, with breast cancer and immunotherapy monitoring expected after clinical validation. AnchorDx and DiaCarta also announced a long-term collaboration to develop and commercialize molecular diagnostic products for the global market, leveraging proprietary technologies for DNA methylation and mutation detection developed by each company. Natera announced plans to expand Signatera to new cancer indications, highlighting plans for ER+/HER2- breast cancer and TNBC. 

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1 | Personalis and Tempus Enter Into a Strategic Collaboration to Advance Cancer Testing Partnership | Personalis, Tempus

2 | AnchorDx, DiaCarta Partner Developing Novel Cancer Screening Test Partnership | AnchorDx, DiaCarta

3 | As Clinical MRD Tests Boom, Natera Expands Efforts to Build Evidence for New Cancer Indications Application Expansion | Natera

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Clinical Trials & Study Results

Natera announced a new phase III study called TREAT ctDNA in collaboration with Menarini Group and European Organisation for Research and Treatment of Cancer (EORTC) Breast Cancer Group. The study will evaluate elacestrant, a new oral endocrine monotherapy, for patients with molecular relapse detected by Signatera, and will enroll around 1,900 patients across 12 countries in Europe. Researchers from Columbia University and Fred Hutchinson Cancer Center explored whether liquid biopsy testing is cost-effective for CRC screening, and concluded that colonoscopy was most cost-effective but liquid biopsy (for those refusing traditional screening) may result in more gain of life-years. ChromaCode highlighted data for their panel test for late stage NSCLC at AMP, showing a sensitivity of 92% and a specificity of 99% (vs. NGS) for the HDPCR assay. ChromaCode aims to serve smaller institutions lacking the resources required to justify adopting NGS in-house, and also promises to provide results in less time than NGS testing.

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1 | Natera Announces Randomized, Phase III TREAT ctDNA Trial in Early-Stage Breast Cancer Trial Announcement | Natera

2 | Cost-Effectiveness of Liquid Biopsy for Colorectal Cancer Screening in Patients Who are Unscreened LBx Economic Evaluation | Columbia University, Fred Hutchinson Cancer Center

3 | ChromaCode Lung Cancer Assay Shows Advantages in New Data at AMP as Company Eyes Next Applications Study Data | ChromaCode

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M&A | VC | Private Equity | Legal

A jury found that Guardant Health willfully infringed two of the University of Washington's duplex sequencing patents in the sale of its FDA-approved Guardant 360 CDx product, as well as all of its commercial products in cancer screening, detection, and characterization. Universal Dx closed a roughly $70 million Series B financing round, and announced a collaboration with Quest Diagnostics to allow exclusive offering of Universal Dx’s Signal-C test for CRC screening in the United States. 

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1 | Federal Jury Finds Guardant Health Willfully Infringes University of Washington Duplex Sequencing Patents Exclusively Licensed to TwinStrand Biosciences, Inc., Awards $83.4M in Damages; PTAB Rejects Invalidity Arguments on UW Patents Patent Lawsuit | Guardant Health, TwinStrand Biosciences

2 | Universal DX Closes $70M Series B Round, Inks Deal With Quest to Provide Colorectal Cancer Test Fundraising, Partnership | Universal Dx, Quest Diagnostics

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Additional Sources

‍Company Announcements & Product Launches

1 | Foundation Medicine Announces Collaboration with Pierre Fabre Laboratories to Develop Companion Diagnostics in Non-Small Cell Lung Cancer Partnership | FMI, Pierre Fabre Laboratories

2 | Stilla Focuses on Ease of Use With New Seven-Channel Digital PCR System Product Launch | Stilla Technologies

3 | PlaqueTec Recruits First Ten Patients in BIOPATTERN Trial Trial Recruitment | PlaqueTec

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Clinical Trials & Study Results

1 | Cell-Free Multi-Omics Analysis Reveals Potential Biomarkers in Gastrointestinal Cancer Patients’ Blood Study Results | Tsinghua University, Peking University First Hospital

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M&A | VC | Private Equity | Legal

1 | Guardant Health Reports Third Quarter 2023 Financial Results and Increases Revenue Guidance Financial Report | Guardant Health

2 | NeoGenomics Inc (NEO) Reports 18% Revenue Increase in Q3 2023 Financial Report | NeoGenomics