Newsletter Update

Liquid Biopsy | November Roundup

December 7, 2021
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Highlights & Summary

September and October 2021 were packed full of promising developments across the Liquid Biopsy (LBx) industry with new product launches, clinical trials, regulatory developments, and much more.

  1. Medicare Publishes Final Local Coverage Determination for Pan-Cancer Immunotherapy Monitoring with Natera's Signatera™ MRD Test
    Coverage Expansion | Medicare
  2. Guardant Health and The Royal Marsden NHS Foundation Trust Announce Partnership to Establish First Guardant Health Liquid Biopsy Testing Service Based in the United Kingdom
    Clinical Adoption | Guardant Health
  3. FDA Grants Breakthrough Designation for Early-Stage Breast Cancer Detection Blood Test Developed by Datar Cancer Genetics
    FDA BDD | Datar Cancer Genetics
  4. Study Shows Guardant360® Liquid Biopsy Test Helps Guide Treatment for Patients with HER2-Driven Metastatic Colorectal Cancer
    Clinical Trial Results | Guardant Health
  5. Merck KGaA, Darmstadt, Germany and Burning Rock Collaborate
    APAC Partnership | Merck, Burning Rock
  6. Bluestar Genomics Presents New Data Showing its Liquid Biopsy Test Detects Pancreatic Cancer Signal
    LDT Announcement | Bluestar Genomics
  7. Introduction of First-Of-A-Kind Plasma-Based Biomarker Screening To Facilitate Identification Of Subjects For Phase 3 Ahead 3-45 Trial Presented At CTAD Conference
    Clinical Trial Update | Eisai, Biogen
  8. Lucence Launches First Liquid Biopsy Screening Study in Partnership with the VA Palo Alto Health Care System
    Clinical Trial Launch | Lucence
  9. Rarecells, Inc. to fund a clinical study at Columbia University of its ISET® -AML test for early detection of Acute Myeloid Leukemia (AML)
    Clinical Trial Launch | Rarecells, Inc.
  10. Study Shows Biocept's Switch-Blocker Technology Enhances Performance of Conventional PCR-Based Liquid Biopsy Assays in Detecting Rare Cancer Mutations
    Study Results | Biocept

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1 | Medicare Publishes Final Local Coverage Determination for Pan-Cancer Immunotherapy Monitoring with Natera's Signatera™ MRD Test

Medicare published a MolDx Local Coverage Determination (LCD) and Billing and Coding Article for the minimal residual disease (MRD) recurrence and treatment response screening of both solid and hematopoietic cancers. The coverage is set to take effect on December, 25, 2021 and specifies coverage for both Natera's Signatera test for pan-cancer immunotherapy monitoring applications as well as Adaptive Technologies' CLONOSEQ for acute lymphoblastic leukemia (ALL), multiple myeloma (MM), and chronic lymphocytic leukemia (CLL) indications on bone marrow specimens. The billing article specifies that only the above listed tests are covered at the moment, but will be updated to reflect newly covered tests, providing an immediate opportunity for additional MRD test providers to gain coverage and go to market. The Signatera determination follows the publication of Natera's INSPIRE study results that showed Signatera's 100% positive predictive value in predicting immunotherapy treatment non-responders 6 weeks into treatment in conjunction with imaging.

2 | Guardant Health and The Royal Marsden NHS Foundation Trust Announce Partnership to Establish First Guardant Health Liquid Biopsy Testing Service Based in the United Kingdom

Guardant Health and The Royal Marsden NHS Foundation Trust, a leading cancer research institution that is part of the UK’s Genomic Laboratory Hub, have announced a partnership that will promote in-house liquid biopsy testing. The goal of this partnership is to increase personalization of cancer treatment for those with late-stage cancer in the UK and expand clinical trial opportunities to patients. The capacities of the deal will be matured by the end of next year, and used for both clinical routine and trials. This is the first partnership of its kind for Guardant in the UK.

3 |FDA Grants Breakthrough Designation for Early-Stage Breast Cancer Detection Blood Test Developed by Datar Cancer Genetics

Datar Cancer Genetics received an FDA Breakthrough Device Designation (BDD) for its TriNetra™ liquid biopsy test intended for the early detection of breast cancer in women 40 years or older. The test screens for circulating tumor cells (CTCs) requiring only 5 mL of blood and has been shown to detect Stage 0 and 1 cancers with high accuracy. In addition to the US, TriNetra™ is CE marked and available in Europe.

4 | Study Shows Guardant360® Liquid Biopsy Test Helps Guide Treatment for Patients with HER2-Driven Metastatic Colorectal Cancer

Results from Guardant Health's Phase 2 TRIUMPH study published in Nature Medicine demonstrated that ctDNA analysis with the Guardant360® liquid biopsy test provided an added benefit in stratifying therapeutic response in HER2-driven metastatic colorectal cancer (mCRC) patients treated with pertuzumab and trastuzumab. The analysis associated a decreased ctDNA fraction three weeks after treatment initiation with therapeutic response and met the primary endpoints: A confirmed objective response rate of 30% in 27 tissue-positive patients and 28% in 25 ctDNA-positive patients. The study promotes Guardant360's clinical utility as a tool for helping guide treatment decisions for patients with metastatic colorectal cancer.

5 | Merck KGaA, Darmstadt, Germany and Burning Rock Collaborate

Burning Rock Biotech Limited of China and Merck KGaA of Germany have entered a collaboration for the development of a companion diagnostic (CDx) for Merck’s MET inhibitor, Tepotinib, in mainland China. Tepotinib is already approved for advanced Non-Small Cell Lung Cancer (NSCLC) in various countries, but currently has low penetration in China. Burning Rock's OncoCompass Target panel, a next-generation sequencing (NGS)-based liquid biopsy (LBx) assay, will provide the basis for the CDx in an effort to promote the effective application of Tepotinib.

6 | Bluestar Genomics Presents New Data Showing its Liquid Biopsy Test Detects Pancreatic Cancer Signal

BlueStar Genomics announced promising study data relating to its non-invasive early-stage pancreatic cancer test, which uses a DNA-based 5-hydroxymethylcytosine (5hmC) enrichment assay with high-throughput sequencing to build predictive machine learning (ML) models. The device’s recent designation as a breakthrough device (BDD) by the FDA and the promising study results, motivated the company’s announcement of a 2022 release of a CLIA compliant laboratory developed test (LDT). The study’s initial results were based on a group of 917 patients with 117 patients diagnosed with pancreatic cancer and 800 non-cancer control patients. The model generated from this population displayed a sensitivity of 51.5% and a specificity nearing 98%. The technology may especially be helpful to those who are diagnosed with new-onset diabetes, as 25% of those with pancreatic cancer develop diabetes priorly.

7 | Introduction of First-Of-A-Kind Plasma-Based Biomarker Screening To Facilitate Identification Of Subjects For Phase 3 Ahead 3-45 Trial Presented At CTAD Conference

Eisai Co. and Biogen Inc. are exploring the use of plasma-based biomarkers in screening Alzheimer's patients for amyloid positron emission tomography (PET)  eligibility in Phase 3 AHEAD 3-45 study. AHEAD 3-45 is a trial focused on accelerating the screening process for Alzheimer's disease (AD) and detecting AD pathology. The study additionally evaluates potential treatments for AD such as lecanemab — an anti-amyloid beta (Aβ) protofibril antibody. In order to improve patient stratification in determining amyloid PET scan necessity, the pre-clinical study will investigate the clinical benefits of screening the Aβ42/40 ratio in a patient's plasma during their initial blood test prior to deciding amyloid PET scan eligibility. Initial results are promising with an AUC of 0.87 in predicting AD patients’ amyloid PET necessity. The novel approach proposes a solution to identifying patients with elevated brain amyloid while reducing the need for more invasive diagnostic PET scans and spinal taps.

8 | Lucence Launches First Liquid Biopsy Screening Study in Partnership with the VA Palo Alto Health Care System

Lucence and the VA Palo Alto Health Care System announced a prospective observational study as part of the LIQUIK clinical trial to analyze Lucence's LiquidHALLMARK® liquid biopsy assay's performance in the early detection of Non-Small Cell Lung Cancer (NSCLC). The study population will consist of 200 adults with NSCLC that is histologically confirmed and will evaluate the sensitivity and specificity of LiquidHALLMARK®  in diagnosing small lung nodules of six to twenty millimeters in size either in combination with positron emission tomography/computed tomography (PET/CT)  or solely by PET/CT. LiquidHALLMARK®  is available to US oncologists as a laboratory developed test (LDT), providing an early-detection non-invasive complement to the sparse lung cancer diagnostic space.

9 | Rarecells, Inc. to fund a clinical study at Columbia University of its ISET® -AML test for early detection of Acute Myeloid Leukemia (AML)

Rarecells, Inc. announced an investigator-sponsored clinical study with Columbia University to evaluate the ISET®-AML test's clinical performance for the early detection of acute myeloid leukemia (AML) in patients with myelodysplastic syndrome (MDS) starting in Q1 2022. The ISET® technology isolates circulating tumor cells (CTCs) from blood samples for any cancer type, then combines immune-morpho molecular analyses, image analyses, and artificial intelligence (AI) to diagnose cancer types.

10 | Study Shows Biocept's Switch-Blocker Technology Enhances Performance of Conventional PCR-Based Liquid Biopsy Assays in Detecting Rare Cancer Mutations

BioCept, Inc. showed that its Switch-Blocker technology has the potential to increase sensitivity of detecting cancer mutations when added to polymerase chain reaction (PCR)-based liquid biopsy (LBx) assays. The technology enriches mutations of interest while reducing signals from normal DNA, leading to increased accuracy and specificity. Results show that the Switch-Blocker can increase sensitivity of allele-specific primer assays by over 200 times. The sensitivity was increased over 1000 times for multiplex competitive allele-specific TaqMan assays. This technology may aid in solid tumour cancer diagnosis using LBx, especially since blood biomarkers occur under 1% MAF.

Headlines are curated by Alex Amram, Hannah Glazier, and Amal Thommil.

Authors
Alex Amram
Analyst
Hannah Glazier
Analyst
Amal Thommil
Analyst
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