Highlights & Summary

Liquid Biopsy (LBx) had an active November, featuring distribution deals and debuted products as well as many trial and study results.
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Featured DeciBio Insights

1 | Worldwide Spatial Biology market forecasted to grow at 30% p.a., reaching ~$1.2B by 2027 – Market Report by DeciBio Consulting Market Report | Miguel Edwards, Cameron Braverman

2 | AI’s Impact on the Clinical Pathology Lab : DeciBio's Q&A with Paige’s CEO Andy Moye Q&A Interview | Katie Gillette, Tina Wang

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Clinical & Regulatory

November highlights include various national test distribution deals across key regions, namely the U.S. and Asia-Pacific (APAC). Natera has been awarded a nationwide contract from the US Department of Veterans Affairs (VA) to provide MRD (minimal residual disease) and treatment monitoring services using its tumor-informed Signatera ctDNA test. Codex Genetics signed on as the exclusive distributor of Guardant Health tests in Hong Kong and Macau. Additionally, KDx Diagnostics signed a distribution deal with EmeritusDx to offer KDx’s urine-based URO17 bladder cancer test to its network of urology practices across the U.S.

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1 | Natera Awarded Contract to Provide Cancer Testing Services to VA Nationwide Distribution Deal | Natera, U.S. VA

2 | Codex Genetics Inks Distribution Deal for Guardant Health Cancer Tests in Asia APAC Distribution Partnership | Codex Genetics, Guardant Health

3 | KDx Diagnostics Inks US Distribution Deal for Bladder Cancer Test U.S. Distribution Partnership | KDx Diagnostics, EmeritusDx 
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Company Announcements & Product Launches

Haystack Oncology plans to launch a tumor-informed, patient specific MRD assay in 2022 with a sensitivity of 1 ppm. Haystack aims to launch clinical testing in 2023, is working on CLIA validation of the assay, and fundraising in Series A. Johns Hopkins University researchers have developed a cfDNA “fragmentome” based machine learning approach for HCC, viral hepatitis, cirrhosis, and NAFLD detection and monitoring. The approach uses WGS and DELFI to determine changes in cfDNA, and can detect HCC with 88% sensitivity and 98% specificity. Bio-Rad Laboratories and NuProbe USA sign licensing and developing for NuProbe’s Blocker Displacement Amplification (BDA) technology. BDA is validated in qPCR, dPCR, Sanger sequencing, NGS, and nanopore sequencing for DNA allele enrichment.

1 | Haystack Oncology to Debut Hypersensitive Residual Cancer Test Based on Hopkins Tech MRD Assay Launch | Haystack Oncology, Johns Hopkins University

2 | Liver Cancer Detection Score Developed With Machine Learning Analysis of Blood Plasma DNA Fragments Novel Fragmentome Assay | Johns Hopkins University, Delfi Diagnostics

3 | Bio-Rad Laboratories, NuProbe USA Ink Licensing and Development Agreement Licensing and R&D Partnership | Bio-Rad Laboratories, NuProbe USA
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Clinical Trials & Study Results

This month saw heavy activity in publications studying liquid biopsy for assessing or predicting response to therapy. For example, InterVenn Bioscience demonstrated a liquid biopsy-based glycoproteomic predictor of immune checkpoint inhibitor (ICI) benefit in advanced NSCLC. Personalis used ctDNA for longitudinal tracking of advanced HCC patients treated with neoantigen targeted personalized cancer DNA vaccine. Guardant Health assessed blood-based TMB (bTMB) across nearly 17,000 newly-diagnosed metastatic patients to evaluate potential responsiveness to ICI, and Nykode Therapeutics used ctDNA monitoring to predict therapy response in patients with advanced HPV16+ cervical cancer. Gritstone Bio also demonstrated patients with mCRC that have “molecular response”, determined by decreased VAF or ctDNA from baseline, show extended overall survival (OS) with individualized neoantigen vaccination in combination with ICIs.

1 | A novel, highly accurate liquid biopsy-based glycoproteomic predictor of checkpoint inhibitor treatment benefit in advanced non-small cell lung cancer Study Results | InterVenn Bioscience

2 | Circulating tumor DNA analysis of advanced hepatocellular cancer (HCC) patients treated with neoantigen targeted personalized cancer DNA vaccine (GNOS-PV02) in combination with plasmid IL-12 (pIL12) and anti-PD1 (pembrolizumab) Clinical Trial Results (NCT04251117) | Geneos Therapeutics, Personalis, INOVIO Pharmaceuticals

3 | Assessment of differences in tumor mutational burden identified on liquid biopsy in 16,870 patients newly diagnosed with metastatic cancer Study Results | Guardant Health, Mayo Clinic

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M&A | VC | Private Equity | Legal

Haystack Oncology, a liquid biopsy startup focused on ctDNA-based MRD testing, announced it raised $56M in Series A financing round. Novigenix raised $14M in first closing of a Series B round, planning to use funds to fast track clinical validation of its NGS-based liquid biopsy CRC screening assay. Early is Good closed a $4M seed funding round which it will use to complete clinical trials for its first product, BCDx, an LDT using nanotechnology to quantify a panel of biomarkers in urine to detect and diagnose bladder cancer earlier. 
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1 | Liquid Biopsy Startup Haystack Oncology Raises $56M in Series A Round Series A Funding | Haystack Oncology, Catalio Capital Management

2 | Novigenix announces first closing of its $20M Series B Series B Funding | Novigenix

3 | Early Is Good Raises $4 Million Seed Round from Social Capital Seed Funding | Early is Good, Social Capital

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Additional Sources 

Company Announcements & Product Launches

1 | LymeX prize competition announces ten Phase 1 winners Competition Award Winners | BlueArc Biosciences, Drexel University College of Medicine, George Mason University, HelixBind, InBios International, Massachusetts General Hospital, Serimmune, T2 Biosystems, Tufts University, Virginia Tech, Cohen Foundation, U.S. HHS

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Clinical Trials & Study Results

1 | Use of HPV16 circulating tumor DNA detected in liquid biopsies to predict response in patients with advanced HPV16-positive cervical cancer Clinical Trial Results (NCT04405349) | Nykode Therapeutics ASA, Roche Pharma AG, Vaccibody AS

2 | Evaluation of liquid biopsy-based plasma copy number burden, DNA methylation and personalized minimal residual disease approach for monitoring molecular response to different drug regimens in metastatic colorectal cancer patient Study Results | EMD Serono, Merck Healthcare KGaA, Predicine

3 | Clinicopathologic characteristics of patients with metastatic colorectal cancer with molecular responses following treatment with an individualized neoantigen vaccine regimen Clinical Trial Results (NCT03639714) | Gritstone bio, Bristol-Myers Squibb

4 | GRAIL CCGA Discovery Results Published in Cancer Cell Reveal Methylation as Promising DNA Hallmark for Multi-Cancer Early Detection CCGA Discovery Results | GRAIL

5 | Biocept Announces Participation in an Investigator-Initiated Study to Better Understand the Development and Progression of Metastatic Breast Cancer to the Central Nervous System Investigator-Initiated Study | Biocept

6 | Myriad Genetics to Submit Hereditary Cancer Risk Variants to ClinVar in 2023 Public Research Contribution | Myriad Genetics, ClinVar