Highlights & Summary

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Liquid Biopsy (LBx) continued to develop through August, with significant activity in early detection applications of LBx, as well as expanding medicare coverage of organ transplant rejection monitoring.

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Featured DeciBio Insights

1 | Blood-Based Cancer Early Detection Testing – Current Clinician Perspectives Ad Board | DeciBio

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2 | MRD Ad Board Ad Board | DeciBio

Clinical & Regulatory‍

Natera announced this month that its Prospera Lung allograft rejection monitoring test has met the necessary molecular diagnostic coverage requirements, and will begin to be covered by Medicare. The test monitors donor-derived cell-free DNA, and is part of Natera’s ongoing effort to build transplant rejection monitoring tools using cell-free genetic material; kidney and heart transplant rejection tools are in development. Relatedly, CareDx’s HeartCare has received Medicare coverage. HeartCare uses AlloMap and AlloSure to monitor for transplant rejection; the former uses gene expression profiling, while AlloSure uses donor-derived cell-free DNA, as in the case of Natera’s Prospera. Finally, a local coverage determination (LCD) application was filed for solid organ allograft rejection molecular assays.

1 | Natera’s Prospera Lung transplant assay approved for Medicare coverage Medicare Coverage | Natera

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2 | CareDx’s HeartCare Multimodality Service Receives Medicare Coverage for Heart Transplant Surveillance | Technology Networks Medicare Coverage | CareDx

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3 | Proposed LCD - MolDX: Molecular Testing for Solid Organ Allograft Rejection (DL38568) Insurance Coverage - Organ Transplants | MolDX

Company Announcements & Product Launches

GRAIL, Cancer Support Community, and Whitman-Walker Institute announced a collaboration in August which will aim to develop strategies to expand the reach of early cancer detection tools. Called the INCLUDE study, it will evaluate outreach practices in an effort to build awareness around early cancer screening, and will focus on groups that have been historically underrepresented in research and care. Singaporean RNA technology company Mirxes announced a partnership with PT Elion Medika Indonesia to commercialize their GASTRClear and LUNGClear microRNA cancer blood tests. These tests will increasingly be manufactured in Indonesia. Through another collaboration, Mirxes will work to optimize multi-cancer blood tests for the Indonesian population.  Additionally, through a Memorandum of Understanding, Mirxes has made plans to establish a manufacturing facility in China’s Zhejiang. Wren Laboratories, through a distribution agreement with Kindstar Globalgene Technology, has brought their NETest molecular neuroendocrine cancer test to China to better monitor tumor status and therapy progression.

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1 | Whitman-Walker Institute, Cancer Support Community and GRAIL Collaborate on Research Aimed at Advancing Health Equity in Cancer Screening and Care Through Multi-Cancer Early Detection Research Collaboration | GRAIL, Whitman-Walker Institute, Cancer Support Community

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2 | Mirxes Inks Ne Deals to Scale Adoption of Early Cancer Detection Solutions in APAC Partnership Agreement | Mirxes, PT Elion Medika Indonesia, Singapore-Zhejiang Economic and Trade Council

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3 | NETest Expanded to China Distribution Deal | Wren Laboratories, Kindstar Globalgene Technology

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Clinical Trials & Study Results

Researchers claim to have found data analysis errors in a recent large scale study that reported correlations between microbes and 33 different cancer types. Errors in the genome database allegedly led to false positive findings of bacterial reads; the authors also assert that errors in transformation of the raw data created an artificial signature. They believe that this invalidates the results, and calls into question those of additional published studies using the same data. The first prospective international retinoblastoma liquid biopsy study to date will be led by a researcher at the Children’s Hospital of Los Angeles who developed a new way to diagnose retinoblastoma by sampling the fluid at the front of the eye. DELFI Diagnostics licensed Johns Hopkins’ GEMINI Technology, which, combined with their approach, could successfully identify early stage lung cancers. GEMINI, or GEnome-wide Mutational Incidence for Non Invasive detection of cancer, is a novel method for identifying somatic genomic alterations in cfDNA.

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1 | Major data analysis errors invalidate cancer microbiome findings Study Sparks Controversy | University of East Anglia, Johns Hopkins University, Micronoma

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2 | Children’s Hospital Los Angeles research to lead first-ever international liquid biopsy retinoblastoma study Research Grant | Children’s Hospital Los Angeles, NIH

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3 | DELFI Diagnostics Licenses GEMINI Technology from Johns Hopkins University: Study Demonstrates High Performance for Early Stage Lung Cancer Detection When Integrated with DELFI Diagnostics's Platform  Study Results | Delfi Diagnsotics, Johns Hopkins University 

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M&A | VC | Private Equity | Legal

Illumina and Guardant have settled a lawsuit in the Delaware federal court and since signed a new long-term supply arrangement and agreed to share specimen samples for cancer research. The companies asked the court to dismiss Illumina’s lawsuit against Guardant that accused Guardant of stealing Illumina’s trade secrets. Agilent has closed their liquid biopsy division, Resolution Bioscience. They originally purchased Resolution Bioscience for $550 million, noting that the kitted liquid biopsy market is too immature for profit at this time. William Blair has initiated coverage of Bio-Techne with an “Outperform” recommendation. The projected annual revenue for Bio-Techne is approximately 22% greater than the year prior. 

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1 | Guardant Health settles Illumina lawsuit over gene-sequencing technology  Settlement | Guardant Health, Illumina

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2 | Agilent closes $550M liquid biopsy unit after failing to find path to profits Unit Closure | Agilent

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3 | William Blair Initiates Coverage of Bio-Techne (TECH) with Outperform Recommendation Stock Coverage | Bio-Techne, William Blair

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Additional Sources

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Company Announcements & Product Launches

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1 | Automation Innovations in Liquid Biopsy and Biobanking Product Launch | Tecan

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Clinical Trials & Study Results

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1 | Sylvester Researcher Leads NCI Grant to Develop Urine Test to Lessen Need for Invasive Biopsies Research Grant | University of Miami Sylvester Comprehensive Cancer Center

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