Highlights & Summary
August showcased new partnerships, CDx regulatory approvals, new clinical trials and study results in liquid biopsy.
Company Announcements & Product Launches
Of note in product launches and expansions this month, Predicine launched their CE-IVD LBx assay, PredicineCARE. This assay identifies over 150 genes to help with clinical trial pairings and therapeutic selection for patients. Guardant Health expanded the utility of their Guardant Reveal LBx test to apply to the detection of recurrent early-stage breast and lung cancers in addition to colorectal cancer (CRC). John Hopkins University developed a Liquid Biopsy for Breast Cancer Methylation (LBx-BCM) assay that utilizes Cepheid’s GeneXpert platform to allow for more decentralized breast cancer testing. Currently, patients undergoing chemotherapy for breast cancer will not know their therapeutic response until imaging is undergone 2 or more months later; LBx-BCM can detect tumor DNA within just hours of application.
1 | Predicine Launches Liquid Biopsy Assay in Europe EU Product Launch, CE-IVD Approval | Predicine
2 | Guardant Health Expands Use of Guardant Reveal™ Liquid Biopsy Test for Residual Disease Detection and Recurrence Monitoring to Include Early-Stage Breast and Lung Cancers Indication, Prognostic Expansion | Guardant
3 | Liquid biopsy test rapidly monitors disease load in patients with advanced breast cancer Product Launch | Johns Hopkins and Cepheid
Clinical & Regulatory
In clinical and regulatory developments this month, Guardant Health’s Guardant360 CDx received an FDA approval as a companion diagnostic for NSCLC patients who may benefit from Astrazeneca and Daiichi Sankyo’s drug ENHERTU — a HER2-directed antibody drug conjugate. Guardant360 CDx can identify patients with HER2 mutations, helping inform treatment eligibility. Outside of NSCLC, Guardant Health was in the news this month for receiving Medicare coverage for Guardant Reveal — a molecular residual disease (MRD) test. This test was the first blood based MRD test available for CRC patients. Now, for Medicare patients in the United States with stage II or stage III CRC, this approval may positively impact their accessibility to this test.
1 | Guardant Health Receives FDA Approval for Guardant360® CDx as Companion Diagnostic for Daiichi Sankyo and AstraZeneca’s ENHERTU® for Treatment of NSCLC Patients With Activating HER2 Mutations Regulatory Approval, CDx | Guardant
2 | Guardant Health Receives Medicare Coverage for Guardant Reveal™ Test | Business Wire Medicare Reimbursement | Guardant Health
Clinical Trials & Study Results
Foundation Medicine, Flatiron Health, and Genentech announced results from a study that compared the ability of FoundationOne CDx and FoundationOne Liquid CDx to detect actionable biomarkers in patients with advanced NSCLC. Genetron Health launched a trial in collaboration with Piedmont Transplant Institute to assess performance of Genetron’s novel HCC (hepatocellular carcinoma) liquid biopsy biomarkers assay for early detection. Similarly, Exact Sciences collaborates with West German Study Group to conduct a study on HR+, HER2- early breast cancer patients to assess Exact’s tumor-informed ctDNA liquid biopsy test for detecting minimal residual disease (MRD) and collecting long-term follow up and outcome data. InterVenn Biosciences also announced the start of enrollment in its colonoscopy study intended to validate their platform for detecting early colorectal cancers and precancerous adenomas from blood.
1 | Initial Analysis of Tumor Profiling From a Prospective Study by Foundation Medicine, Flatiron Health and Genentech Demonstrates Value of Tissue and Liquid Comprehensive Genomic Profiling in Patients with Advanced Non-Small Cell Lung Cancer Study Results (NCT04180176) | Foundation Medicine, Flatiron Health, Genentech
2 | Novel Biomarker Assay for HCC Early Detection Clinical Trial Announcement | Genetron Health
3 | Exact Sciences and West German Study Group Announce New Study to Validate Detection of Minimal Residual Disease in Early-Stage Breast Cancer Patients Study Announcement | Exact Sciences, West German Study Group
M&A | VC | Private Equity | Legal
This month, Personalis sued Foresight Diagnostics on the basis of patent infringement. Personalis alleges that they have property related to molecular residual disease detection by using whole genome sequencing, which is used in their NeXT Personal test.
1 | Personalis Sues Foresight Diagnostics, Alleging Patent Infringement Legal | Personalis
Additional Sources
Company Announcements & Product Launches
4 | Noninvasive Tests to Detect Kidney Transplant Rejection: The Search Continues Company Announcement | Olaris
Clinical & Regulatory
No Additional Sources.
Clinical Trials & Study Results
4 | InterVenn Biosciences Announces Start of Enrollment in Colonoscopy Study Study Launch | Intervenn
5 | Guardant Health Announces New Data from its Portfolio of Blood Tests and GuardantINFORM™ Real-World Clinical-Genomic Platform at IASLC 2022 World Conference on Lung Cancer Study Results Announcement | Guardant Health
6 | Personalis in Partnership with BC Cancer to Assess Clinical and Economic Benefits of ctDNA for Colorectal and Pancreatic Cancers Partnership, Study | Personalis, BC Cancer
7 | Extracellular Vesicles Show Promise as Early-Stage Liver Cancer Diagnostic Method Validation | UCLA
M&A | VC | Private Equity | Legal
No Additional Sources.
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