Highlights & Summary

Liquid Biopsy (LBx) continued to develop through April, featuring more Medicare coverage decisions as well as research collaborations and study results.

Clinical & Regulatory

‍Palmetto GBA is now covering Guardant’s Guardant360 Response Test, the first blood-only test using ctDNA levels to understand therapy responses in cancer patients. Palmetto GBA has coverage for other Guardant products, including the Guardant360 assay, Guardant360 TissueNext, and Guardant Reveal. Palmetto GBA also administered coverage for Epic Sciences’ 56 gene ctDNA panel for the genomic profiling of breast cancer, DefineMBC. Additionally, MDxHealth SA’s Select mdx Prostate Cancer, a urine based mRNA test to assess a patient’s risk for prostate cancer, received reimbursement for Medicare patients through Palmetto GBA’s MolDX program. As far as clinical news, NHS England began rolling out a genetic test for Lynch syndrome using a blood draw - this program guarantees genetic analysis for Lynch syndrome for those diagnosed with certain endometrial and bowel conditions. 

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1 | Guardant Health Receives Medicare Coverage for Guardant360 Response to Monitor Cancer Patient Response to Immunotherapy Medicare Coverage | Guardant Health

2 | Epic Sciences Announces Medicare Coverage for Breast-Cancer Focused ctDNA Gene Panel Medicare Coverage | Epic Sciences

3 | Foundational LCD Covers Select mdx for Prostate Cancer Medicare Coverage | MDxHealth

Company Announcements & Product Launches

Personalis entered a collaboration with multiple UK academic organizations to deploy NeXT Personal, an LBx assay, for the TRACERx study, a lung cancer initiative funded by Cancer Research UK. The purpose of this initiative is to promote more personalized medicine for lung cancer patients and combat the challenge of how typical imaging techniques used to understand lung cancer patients’ statuses are often limited in sensitivity. ANGLE and BioView Ltd. entered an agreement to develop an LBx CTC HER2 assay for breast cancer patients using ANGLE’s Parsortix PC1 Clinical system and Bioview’s microscopy systems in order to understand the expression of HER2 in CTCs. They will use Abbott’s PathVysion HER2 DNA probe kit as well. The US-based Genomic Testing Cooperative (GTC) and Japan’s Sysmex Inostics (a subsidiary of Sysmex) entered a strategic partnership to advance therapeutic discovery and development via the commercialization of GTC’s assay services including: Solid Tumor Profile Plus, Liquid Trace Hematology Profile, Liquid Trace Solid Tumor Profile and Hematology Profile Plus. Sysmex also entered into a collaboration with Juntendo University and ThinkCyte to improve detection and treatment of chronic myelogenous leukemia (CML). The efforts hinge upon ThinkCyte’s Ghost Cytometry, an AI-driven technology to characterize and sort cells’ structures, shapes, and sizes. This month also brought about multiple partnerships to support efforts in transplantation, such as between CareDx and Miromatix, Thermo Fisher Scientific and Devyser, and Karius and eGenesis. 

1 | Personalis Joins Top UK Cancer Research Organizations to EValuate Earlier Cancer Recurrence Detection Though Groundbreaking Study Trial Collaboration | Personalis, Cancer Research UK, University College London, Francis Crick Institute

2 | ANGLE announces partnership with BioView Company Partnership | ANGLE, BioView

3 | Sysmex, GTC partner for commercialisation of assay services Company Partnership | Sysmex, GTC 

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Clinical Trials & Study Results

Immunocore presented new KIMMTRAK data at AACR strongly associating on-treatment ctDNA reduction with longer overall survival (OS) in patients with metastatic uveal melanoma. Authors from Novartis published an article presenting a classification approach to detect clonal hematopoiesis (CH) from cfDNA sequencing alone. Applied to a cohort of 4324 oncology clinical cfDNA samples, they determined 30.3% of patients have evidence of CH, and demonstrated increased inflammation in patients with CH, both systematically and in the tumor microenvironment. C2i Genomics announced preliminary study results showing ctDNA (detected by C2inform assay) can be used as a prognostic marker after neoadjuvant treatment in locally advanced rectal cancer patients to determine the need for immediate surgical resection and the potential for organ preservation. Guardant Health and Parker Institute for Cancer Immunotherapy launched a research collaboration to study the correlation between molecular cancer biomarkers and immunotherapy response, and Exai Bio also presented data on the sensitivity and specificity of its proprietary RNA- and AI-based liquid biopsy platform for NSCLC early detection at AACR.

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1 | Immunocore presents new KIMMTRAK data confirming association between early ctDNA reduction and longer overall survival  Data Results | Immunocore

2 | Clonal Hematopoiesis Detection in Patients with Cancer Using Cell-Free DNA Sequencing Study Result | Novartis

3 | C2i Genomics study finds circulating tumor DNA can predict treatment outcomes in patients with locally advanced rectal cancer enrolled for organ preservation Preliminary Study Results | C2i Genomics, Memorial Sloan Kettering

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M&A | VC | Private Equity | Legal 

Quest Diagnostics will acquire Haystack Oncology, and plans to adapt Haystack’s MRD test for new clinical lab services in colorectal, breast and lung cancer indications. Quest Diagnostics will pay $300M at closing, and up to $150M in the future based on milestones. Foresight Diagnostics completes a $58.8M Series B financing round to fund clinical development and commercialization of its PhasED-seq MRD testing platform. Foresight is in ongoing litigation with Personalis over alleged MRD patent infringement. Mercy Bioanalytics closes a $41 million Series A financing round to fund development and commercialization of the Mercy Halo test for high-risk lung cancer screening, as well as advance clinical programs in additional indications.

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1 | Quest Diagnostics to Acquire Haystack Oncology, Adding Sensitive Liquid Biopsy Technology for Improving Personalized Cancer Care to Oncology Portfolio Acquisition | Quest Diagnostics, Haystack Oncology

2 | Foresight Diagnostics Closes $58.8M Series B Round Series B Funding | Foresight Diagnostics

3 | Mercy BioAnalytics Raises $41 Million To Advance Mercy Halo Liquid Biopsy Platform for Early Cancer Detection - Framingham Series A Financing | Mercy BioAnalytics

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Additional Sources

‍Clinical & Regulatory

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1 | Life-saving NHS test helping to diagnose thousands with cancer-causing Lynch syndrome  Public LBx Testing Program | NHS UK

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Company Announcements & Product Launches

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1 | Juntendo University, Sysmex and ThinkCyte collaborate to advance the early detection and treatment of blood cancer Partnership Announcement | Juntendo University, Sysmex, ThinkCyte

2 | CareDx and Miromatrix Announce Exclusive Partnership to Advance Research Using Bioengineered Organs for Human Transplantation Company Partnership | MiroMatrix, CareDx

3 | Devyser Enters Agreement with Thermo Fisher Scientific for Commercialization of Devyser’s Post-Transplant NGS Products Distribution Agreement | Devyser, Thermo Fisher

4 | Agena Bioscience and nRichDX Announce Commercial Partnership to Create Solutions for the Extraction and Detection of Liquid Biopsy Analytes Company Partnership | Agena Bioscience, nRichDX

5 | Stilla Tech and Atila BioSystems Co-Develop Digital PCR Kits for Oncology Company Partnership | Stilla Technologies, Atila BioSystems

6 | Karius and eGenesis partner to help accelerate xenotransplantation for patients in need of organ transplants Company Partnership | Karius, eGenesis

7 | ReadyGo Diagnostics and Gemina Laboratories enter an assay development agreement for the rapid detection of mycobacterium tuberculosis (MTB) Company Partnership | ReadyGo Diagnostics, Gemina Laboratories

8 | Mission Bio Partners with Fulgent Genetics to Broaden Accessibility of Single-Cell Multi-Omics for Drug Development and Clinical Research  Company Partnership | Mission Bio, Fulgent Genetics

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Clinical Trials & Study Results

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1 | Guardant Health and Parker Institute for Cancer Immunotherapy (PICI) Launch Research Collaboration to Study Connection Between Cancer Biomarkers and Immunotherapy Treatment Response Research Partnership | Guardant Health, Parker Institute for Cancer Immunotherapy

2 | Exai Bio Presents New Non-Small Cell Lung Cancer Early Detection Data at the American Association for Cancer Research (AACR) 2023 Annual Meeting Study Results | Exai Bio

3 | GC Genome Corp. Releases Results on Liquid Biopsy Study | Inside Precision Medicine Study Results | GC Genome

4 | Early detection of molecular residual disease and risk stratification for stage I to III colorectal cancer via circulating tumor DNA methylation Study Results | Fudan University Shanghai Cancer Center

5 | Evaluation of outcomes in patients (pts) with stage 4 non-small cell lung cancer (NSCLC 4) harboring actionable oncogenic drivers (AOD) when treated prior to report of mutation without tyrosine kinase inhibitors (TKI): An Integra Connect Database (ICD) retrospective observational study Study Results | Integra Connect

6 |  Multicenter study finds BioFire joint infection panel shows high accuracy despite limitations Study Results | BioMerieux

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M&A | VC | Private Equity | Legal

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1 | Epic Sciences Raises $24M in Series G Financing to Continue Funding Commercialization of DefineMBC Series G Financing | Epic Sciences

2 | Identifai-Genetics Closes a Post-Seed Fundraising Round of USD 3.3M Post-Seed Fundraising | Identifai-Genetics