Highlights & Summary

Marching on with more liquid biopsy (LBx) news! The past month brought new insurance coverage for MRD, partnerships, and several funding and trial announcements.

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Featured DeciBio Insights

1 | Pharma ROI Ad Board | New Product Offering: Report, Transcripts, or Bundle | Colin Enderlein

2 | NGS Manufacturer Market Ad Board | New Product Offering: Report, Transcripts, or Bundle | Colin Enderlein

3 | Liquid Biopsy 2023 Forecast: Clinicians’ Perspectives Podcast | Amal Thommil, Alex Amram, Julia Kirkland

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Clinical & Regulatory

Invitae’s Personalized Cancer Monitoring (PCM) MRD assay received commercial coverage in all solid tumors by Blue Shield of California. This policy considers the test medically necessary for patients with stage I-IV cancer after surgical intervention. Guardant Health submitted its blood-based CRC screening test, Shield, to the FDA for premarket approval. This application includes results from the 20,000 patient ECLIPSE study which found Shield to have 83% sensitivity and 90% specificity for detecting CRC.

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1 | Invitae’s Personalized Cancer Monitoring Assay Gets First Commercial Coverage MRD Commercial Coverage | Invitae

2 | Guardant Health Submits Colorectal Cancer Screening Test to FDA for Premarket Approval Premarket Approval Submission | Guardant Health

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Company Announcements & Product Launches 

REVEAL GENOMICS’ proprietary machine-learning multi-gene signatures were applied to samples and ultimately showed that multi-gene signatures that correspond to intricate features can be recognized in ctDNA. One of the signatures, RB-LOH, was identified in ~25% of HR+/HER- patients who did not respond well to CDK4/6 inhibitors. Bionano Laboratories has expanded its clinical testing menu with the launch of two LDTs that use optical genome mapping: the OGM-Dx Postnatal Whole Genome SV and the OGM-Dx Prenatal Whole Genome SV. These tests look at structural variants to identify a range of conditions, such as epilepsy, developmental delays, or autism spectrum disorders. Personalis and AstraZeneca announced the continuation of a collaboration to support the development of Personalis’ whole-genome-informed ctDNA test for MRD. Caris Life Sciences and Incyte have also entered a strategic research partnership; Incyte will use Caris’ data findings and analytics capabilities to promote biomarker discovery and optimize oncology program decision making. For drug candidates developed during this agreement, patients participating in clinical trials under Incyte will be monitored via Caris’ tissue and LBx assays.

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1 | REVEAL GENOMICS®´ Breakthrough Technology Enters the Liquid Biopsy Field in Oncology | Business Wire Product Development | REVEAL GENOMICS

2 | Bionano Laboratories Expands its Clinical Testing Menu with Launch of OGM-Based Laboratory Developed Tests (LDTs) for Prenatal and Postnatal Analysis LDT Expansion | Bionano

3 | Personalis, AstraZeneca Extend Collaboration Around Residual Cancer Detection Test  MRD Collaboration | Personalis, AstraZeneca

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Clinical Trials & Study Results 

A research team composed of individuals with various affiliations, including Roche, Foundation Medicine, and Genentech, assessed ctDNA across 5 time points in 466 NSCLC patients from the IMpower150 study in order to understand the utility of ctDNA in risk stratification of patients. Their model ultimately found that ctDNA could potentially be more clinically efficacious for screening as compared to traditional radiographic imaging. Sermonix Pharmaceuticals and Guardant Health will be collaborating in a Phase 3 clinical study to compare treatments in patients with locally advanced or metastatic ER+/HER2- breast cancer patients with an ESR1 mutation. Four hundred subjects will be enrolled for the study, and they will be prospectively screened for ESR1 mutations via the Guardant360 CDx LBx NGS test. Researchers with the NIH completed a retrospective observational study to understand how DNA sequencing of pretransplant blood in patients with AML may reveal levels of subsequent risk of relapse or death. Study results indicated that for patients in first remission prior to a hematopoietic cell transplant, higher presence of FLT3 or NPM1 variants was associated with a greater risk for relapse or poorer survival outcomes.

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1 | A Longitudinal Circulating Tumor DNA-Based Model Associated with Survival in Metastatic Non-Small-Cell Lung Cancer Study Results | Roche, Foundation Medicine, Genentech

2 | Sermonix Pharmaceuticals Announces Initiation of Phase 3 ELAINE-3 Study of Lasofoxifene Plus Abemaciclib in Pre- and Post-Menopausal Patients with Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation as Detected by Guardant Health’s Guardant360 CDx Liquid Biopsy Study Launch | Sermonix Pharmaceuticals, Guardant Health

3 | DNA sequencing to detect residual disease in adults with acute myeloid leukemia prior to hematopoietic stem cell transplant Study Results | NIH

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M&A | VC | Private Equity | Legal

Droplet Biosciences announced a $8 million seed investment to establish proof of concept for their non-invasive approach of accessing lymph through surgical drain fluid after tumor resection. This procedure can be used to detect residual disease in head and neck cancer patients after surgery. GenoME Diagnostics raised $1.4 million in pre-series A funding to develop OvaME, a product that improves on current ovarian cancer blood tests by measuring patented DNA methylation markers in a blood sample. The startup plans to file for regulatory approval in the EU, expanding to the UK and North America shortly after. Illumina shares rise 18% as activist investor Carl Ichan launches a proxy battle for board seats claiming the company’s acquisition of Grail cost shareholders $50 billion and showed gross negligence. This battle comes as Illumina opposes the European Union order to divest Grail after the company closed the acquisition deal before securing regulatory approval. The University of Buffalo, alongside USC, For-Robin, and Roswell Park, has secured $3.5 million to develop a better screener for lung cancer. Investigators are looking into developing a light-based biosensor, “Exosome Protein microRNA OneStop Sensor (EXO-PROS)”, that could potentially identify biomarkers in tumor-derived exosomes. 

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1 | Droplet Biosciences Announces Lymph Diagnostic Platform to Help Prevent Cancer Recurrence | Business Wire Seed Investment | Droplet Biosciences, The Engine

2 | Belfast-Based GenoME Raises 1.4 million GBP to Help With Earlier Detection of Ovarian Cancer Pre-Series A Round Funding | GenoME

3 | Activist investor Icahn launches proxy battle at Illumina | Nasdaq Proxy Battle | Illumina, Grail

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Additional Sources

Company Announcements & Product Launches

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1 | Caris Life Sciences and Incyte Enter Into Broad Precision Medicine Partnership to Advance Incyte's Oncology Pipeline Research Partnership | Caris Life Sciences, Incyte 

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M&A | VC | Private Equity | Legal

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‍1 | UB and partners secured $3.5M to develop new lung cancer screening test Product Development | University of Buffalo