Highlights & Summary

Liquid Biopsy (LBx) continued to develop through June, featuring new clinical and research collaborations as well as trial launches and study results spurred on by ASCO.

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Clinical & Regulatory 

Foundation Medicine’s FoundationOne Liquid CDx received FDA approval to be paired with Pfizer’s encorafenib and Eli Lilly’s cetuximab to aid therapy selection for patients with colorectal cancer. This marks FoundationOne Liquid CDx’s 10th approval. Circular Genomics, which analyzes circular RNA to predict patients’ responses to psychiatric medications, continues to work towards a launch next year. Circular RNA can be collected from a blood draw, and has interesting implications in PGx (pharmacogenetics) given its ability to cross the blood-brain barrier. In the world of policy, this month included the introduction of the Medicare Multi-Cancer Early Detection (MCED) Screening Coverage act, an act that ensures medicare coverage for innovative MCED tests. The bipartisan bill already has support from over 500 leading healthcare organizations country-wide. 

1 | Foundation Medicine’s Latest Companion Diagnostic Nod Pairs Its Blood Test with Pfizer’s Braftovi Combo FDA Approval | Foundation Medicine, Pfizer

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2 | Circular Genomics Sees More Direct PGx Assay Through Brain-Derived Circular RNA New Assay | Circular Genomics

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3 | Bill to provide Medicare coverage for cancer screening tests introduced in Senate  EDx Medicare Legislation | FDA, CMS, US Senate 

Company Announcements & Product Launches 

In June, Labcorp launched their Plasma Focus liquid biopsy assay, which requires only whole blood to profile cfDNA, and identify biomarkers spanning 33 genes, to inform targeted therapy for patients with known, late-stage cancers of several types. The test is the product of Labcorp’s acquisition of Personal Genome Diagnostics (PGDx), which closed in February for a total value of $575M. Walgreens and Freenome have announced a partnership which will see Walgreens, in collaboration with Curebase, supporting enrollment for candidates for Freenome’s Sanderson study and conducting blood draws in Walgreens locations. The study aims to test a blood-based early cancer detection assay which Freenome is developing. Genomill and iCAN, the flagship national cancer research program of Finland, have partnered to develop Genomill’s blood-based cfDNA assay. Initially, the duo will focus on MRD and Tx selection for colorectal and lung cancers.

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1 | Labcorp launches liquid biopsy to detect cancer-related biomarkers  Product Launch | Labcorp, PGDx

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2 | Walgreens and Freenome Announce Multi-year Partnership  Company Partnership | Freenome, Walgreens, Curebase

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3 | Genomill and Finland's Cancer Research Flagship iCAN Partner To Improve Cancer Detection Using an Extensive Biobank Cohort  Company Partnership | Genomill, Finland iCAN

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Clinical Trials & Study Results 

ASCO’s annual conference this month introduced a wide selection of LBx related studies. One study in melanoma investigating efficacy of mRNA-4157/V940 and pembrolizumab used Inivata’s RaDaR assay to identify and prioritize analysis of ctDNA for MRD detection. Study findings indicated that MRD detection by plasma ctDNA can be associated with recurrence free survival. Another study investigating pembrolizumab with oxaliplatin and capecitabine in patients with metastatic esophagogastric cancer utilized tumor-informed ctDNA for longitudinal disease monitoring. Investigators used Personalis’ NeXT Personal Assay, with conclusions supporting that tumor-informed plasma-based ctDNA profiling in this cancer type may detect clinically actionable variants during treatment. A study of over 450 patients with curatively resected colon cancer found that ctDNA may have benefit to guiding post-surgical treatment, in which those with ctDNA presence after surgery and who subsequently pursued adjuvant treatments derived considerable benefit. Cancer therapy-related cardiac dysfunction (CTRCD) is a potential obstacle for patients undergoing treatments - a study analyzed cfDNA of cardiomyocyte origin to determine if this can serve as an indicator of toxicity for patients undergoing treatment for ERBB-2+ breast cancer. Results indicated that a higher cardiomyocyte cfDNA level after anthracycline chemotherapy could indicate higher risk for CTRCD. 

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1 | Minimal Residual Disease By Circulating Tumor Dna As A Biomarker Of Recurrence Free Survival In Resected High-Risk Melanoma Patients Treated With mRNA-4157/V940, A Personalized Cancer Vaccine, And Pembrolizumab Study Results | Moderna, Inivata

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2 | Ultra-sensitive, tumor-informed ctDNA profiling in patients with gastroesophageal cancer and treated with pembrolizumab and longitudinal ctDNA kinetics Trial Results | Personalis

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3 | Liquid Biopsy Can Help Identify the Need for Adjuvant Therapy in Stage II Colon Cancer | ASCO  Trial Results | National Health and Medical Research Council (AUS), Virginia and Ludwig Fund for Cancer Research, Marcus Foundation, NIH

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M&A | VC | Private Equity | Legal 

Illumina appeals order to divest the Grail acquisition, claiming the FTC has gone to “unprecedented lengths” to stop the merger including “colluding” with European regulators. Illumina claims the FTC’s blockage has delayed commercialization of Grail’s Galleri test. Four hundred patients received erroneous results on their cancer status from Grail due to vendor PNWHealth’s software error. Grail states that the software issue has been resolved, patients have been contacted, and the error was not caused by an incorrect Galleri result. Quest Diagnostics completed an acquisition of Haystack Oncology. Haystack’s ctDNA based MRD technology will be incorporated into development of blood-based clinical lab services for solid tumors available in 2024.

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1 | Illumina appeals FTC’s order to divest Grail with plea for cancer screening test Antitrust Charges Appeal | Illumina, Grail, Federal Trade Commission 

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2 | Grail vendor PNWHealth software error misinforms Galleri test users 

Software Protection | Grail

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3 | Quest Diagnostics Completes Acquisition of Haystack Oncology, Adding Sensitive MRD Liquid Biopsy Technology to Cancer Diagnostics Portfolio  Acquisition| Quest Diagnostics, Haystack Oncology

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Additional Sources

Company Announcements & Product Launches

1 | IMBdx and AstraZeneca expand targeted therapies partnership to promote uptake of liquid biopsy  Company Partnership | IMBdx, AstraZeneca

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2 | Foundation Medicine Announces Collaboration with Merck KGaA, Darmstadt, Germany to Develop Companion Diagnostics for Selected Marketed and Pipeline Treatments Company Collaboration | Foundation Medicine, Merck KGaA

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3 | Myriad Genetics, MD Anderson Partner to Study MRD Testing in Renal Cell Carcinoma Research Collaboration | Myriad Genetics, MD Anderson

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Clinical Trials & Study Results

1 | Association of ultra-sensitive ctDNA assay to identify actionable variants and response to immune checkpoint inhibitor (ICI) therapy in metastatic melanoma Study Results | University Medical Center Hamburg-Eppendorf, German Skin Cancer Foundation

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2 | Association of Circulating Cardiomyocyte Cell-Free DNA With Cancer Therapy-Related Cardiac Dysfunction in Patients Undergoing Treatment for ERBB2-Positive Breast Cancer  Study Results | Memorial Sloan Kettering Cancer Center, Duke Cancer Institute

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M&A | VC | Private Equity | Legal 

1 | Illumina's Board of Directors elects two experienced Independent Directors to Board  Board Member Elections | Illumina

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