Newsletter Update

Liquid Biopsy Fall 2021 Update

November 4, 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. FDA Grants Breakthrough Device Designation for Biological Dynamics' Early-stage Pancreatic Cancer Detection Test
    Regulatory Approval | Biological Dynamics
  2. Twist Alliance Pan-Cancer Methylation Panel Global Launch Event - AnchorDx and Twist
    Product Launch | Twist, AnchorDx
  3. New Ultra-Sensitive Leukemia Blood Test Delivered by Sysmex Inostics
    Product Launch | Sysmex Inostics
  4. Natera launches lung DNA test for catching transplant rejections
    Product Launch | Natera
  5. miR Scientific Presents Groundbreaking Data on the Exceptional Accuracy of its Prostate Cancer Liquid-Biopsy Test
    Study Results | miR Scientific
  6. Natera Announces New Publication Validating Signatera® Velocity Metric to Improve Cancer Management
    Study Results | Natera
  7. Natera's Signatera® Test Selected for NRG Oncology's Landmark CIRCULATE-US Study of MRD-Guided Treatment in Stage II-III Colon Cancer
    Clinical Trial Update | Natera
  8. Lucence and Yemaachi Launch the AMBER Study for Genomic Alterations in Breast Cancer in Women in Africa
    Clinical Trial Launch | Lucence, Yemaachi
  9. Circulating tumor DNA from patients with advanced colorectal cancer is enriched for EGFR extracellular domain mutations
    Study Results | Foundation Medicine
  10. Clinical Genomics Announces Expansion of Medicare Coverage
    Coverage Expansion | Clinical Genomics

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1 | FDA Grants Breakthrough Device Designation for Biological Dynamics' Early-stage Pancreatic Cancer Detection Test

Biological Dynamics, Inc.'s liquid biopsy assay Exo-PDAC has received breakthrough device designation from the FDA to detect pancreatic ductal adenocarcinoma (PDAC). By 2040, PDAC is predicted to be the second leading cause of cancer-related deaths. The assay is run on the Verita platform by Biological Dynamics that utilizes lab-on-a-chip (LOC) AC electokinetics (ACE) technology for a unique direct-to-analyte approach, removing the need for sample prep to measure multiple classes of biomarkers in a single sample. View Source

2 | Twist Alliance Pan-Cancer Methylation Panel Global Launch Event - A Strategic Collaboration Between AnchorDx and Twist Bioscience for Pan-Cancer Liquid Biopsy

The Twist Alliance Pan-Cancer Methylation Panel was launched globally on September 24 and includes DNA methylation library preparation and targeted enrichment for NGS. The panel was developed by AnchorDx in collaboration with Twist Bioscience over a two-year period and covers 47 disease entities from The Cancer Genome Atlas (TCGA) and 31 cancer types, each represented by ~1000 informative genomic regions. View Source

3 | New Ultra-Sensitive Leukemia Blood Test Delivered by Sysmex Inostics

Sysmex Inostics has created an NGS panel to test for minimal residual disease (MRD) in those with acute myeloid leukemia (AML). The AML-MRD-SEQ test is CLIA-validated and requires blood samples. It analyzes 20 genes and up to 68 regions of these genes to aid in allowing for early clinical intervention. One notable marker includes NPM1, which may even aid in prognoses. This test is at least 50% and up to 100% more sensitive than pan-cancer tests available, providing utility to the AML community that loses 10,000 lives a year.  View Source

4 | Natera launches lung DNA test for catching transplant rejections

Natera announced the commercial launch of its Prospera Lung liquid biopsy test for monitoring lung transplant allograft rejection through SNP massively-multiplexed PCR (mmPCR) of cfDNA. The announcement comes shortly after the completion of a prospective clinical study conducted through Ohio State University (OSU) on 104 organ recipients, which produced a 97.33% negative predictive value when comparing 204 blood samples and lung tissue biopsies. Prospera has already been clinically validated in for kidney and heart transplants.  View Source

5 | miR Scientific Presents Groundbreaking Data on the Exceptional Accuracy of its Prostate Cancer Liquid-Biopsy Test

miR Scientific presented data at the American Urological Association's (AUA) 2021 Meeting from their 1,400+ patient cross-validation study, demonstrating their non-invasive miR Sentinel Prostate Cancer Test had a predictive accuracy of over 90% for detecting and risk-stratifying prostate cancer in needle biopsy-eligible men from a single urine sample analysis of small non-coding RNAs (sncRNA) and a proprietary Statistical Classification Algorithm. The test also showed >95% concordance with conventional core needle biopsy and a negative predictive value of 96% in identifying individuals with non-clinically significant cancer. The miR Sentinel Prostate Cancer Test has a Breakthrough Device Designation by the FDA is set to be commercially availble in the United States and Puerto Rico at the end of the year.  View Source

6 | Natera Announces New Publication Validating Signatera® Velocity Metric to Improve Cancer Management

Natera published a new study in Clinical Cancer Research demonstrating Signatera's ability to stratify MRD-positive patients with early-stage CRC, assess tumor growth rates, and predict patient survival with their ctDNA velocity metric. Key findings from the multi-center study of 168 stage III CRC patients: Signatera detected CRC recurrence a median 8.7 months earlier than CT imaging; MRD-positive patients with slow-growing tumors (avg. 27% ctDNA increase/month) had OS similar to no relapse, while fast-growing tumors (avg. 137% ctDNA increase/month) had a 3-year OS of 37.5%, and persistent ctDNA clearance during and after ACT had 100% 3-year RFS, while transient ctDNA cleance had 0% 3-year RFS. View Source

7 | Natera's Signatera® Test Selected for NRG Oncology's Landmark CIRCULATE-US Study of MRD-Guided Treatment in Stage II-III Colon Cancer Natera has entered an agreement with NRG Oncology to apply its Signatera Test in CIRCULATE-US - a 2,000 patient, multi-center clinical trial to investigate MRD-guided treatment strategies for patients with stage II-III colon cancer following resection. Standard-of-care guidelines recommend adjuvant chemotherapy for all stage-III and high-risk stage-II patients, while only 20-25% see improvement, providing a significant opportunity for Signatera to stratify patients based on ctDNA and lead to a more refined and effective treatment pool. Signatera is a tumor-informed ct-DNA MRD LBx test available for both clinical and research use with three Breakthrough Device Designations by the FDA for multiple cancer types and indications.  View Source

8 | Lucence and Yemaachi Launch the AMBER Study to Detect and Characterize Genomic Alterations in Breast Cancer in Women in Africa and Expand Liquid Biopsy Access

Lucence and Yemaachi Biotech are collaborating to characterize and understand the genomics of breast cancer in women of African descent. Only 2% of genomic study participants are of African descent compared to 78% of European ancestry. This "AMBER study" is an observational trial exploring cfDNA liquid biopsy assays (Lucence's LiquidHALLMARK) for identifying actionable genetic mutations (e.g. PIK3CA, BRCA1/2, ESR1) in metastatic breast cancer patients in Ghana.  View Source

9 | Circulating tumor DNA (ctDNA) from patients (pts) with advanced colorectal cancer (CRC) is enriched for EGFR extracellular domain (ECD) mutations

Comparisons of ctDNA analysis from plasma using FoundationOneLiquid CDx to tissue CGP using FoundationOne CDx showed relativly good concordance (positive percent agreement between F1LCDx and F1CDx for specific variants ranged from 62-75%, but increased to 82-100% in patients with tumor fraction >10%). Liquid CGP contained a rich ctDNA signal and was enriched in mutations for EGFR and clonal hematopoiesis genes compared to tissue CGP. Detection of KRAS and BRAF alterations, targetable fusions, and potential resistance mutations suggests liquid CGP is a viable alternative to tissue CGP.  View Source

10 | Clinical Genomics Announces Expansion of Medicare Coverage

Novitas Solutions Inc. updated its Local Coverage Determination “Biomarkers for Oncology” (L35396) to include COLVERA®. Colvera is the first liquid biopsy test available for CRC: A mutation agnostic LDT developed by Clnical Genomics for MRD assesment and reccurence monitoring of CRC patients targeting aberrant methylation of the BCAT1 and IKZF1 genes. The test will be billed under CPT code 0229U for medically necessary LDTs and is reimbursable to all eiligible Medicare and Medicare Advantage patients by the Centers for Medicare and Medicaid Services (“CMS”). View Source

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

Authors
Alexander Amram
Analyst
Hannah Glazier
Analyst
Amal Thommil
Analyst
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