Highlights & Summary
Liquid Biopsy (LBx) had an active January, featuring distribution deals and debuted products as well as many trial and study results.
Featured DeciBio Insights
1 | MRD Ad Board Reports | New Product Offering: Report, Transcripts, or Bundle | Colin Enderlein
2 | DeciBio Podcast Announcement! Liquid Biopsy 2023 Forecast: Clinicians’ Perspectives Podcast | Amal Thommil, Alex Amram, Julia Kirkland
3 | Spatial Biology Market Report - First Edition: 2022 | Market Report | Andrew Aijian, Cameron Braverman, Rebecca Burnham, Colin Enderlein
Clinical & Regulatory
Burning Rock is starting 2023 off with a FDA Breakthrough Device Designation for its Multi-Cancer Detection Blood Test (MCDBT), OverC. OverC is intended for detection of esophageal, liver, lung, ovarian, and pancreatic cancer for adults between 50-75 years of age. Guardant Health also has FDA news, with their Guardant360 CDx receiving FDA approval as a companion diagnostic for ORSERDU in some breast cancer patients. Foundation Medicine’s FoundationOne Liquid CDx received FDA approval as a companion diagnostic for Rozlytrek this month as well. This is relevant for ROS1+ NSCLC patients and patients with NTRK fusion-positive solid tumors. Another FDA breakthrough device designation occurred this month, but for Micronoma’s OncobiotaLUNG, a liquid biopsy assay for lung carcinomas. Looking at the European market, Geneseeq received a CE mark for their MRD and multi-cancer early detection (MCED) kits for solid tumors.
1 | Burning Rock Received FDA Breakthrough Device Designation for its OverC™ Multi-Cancer Detection Blood Test FDA BDD | Burning Rock
2 | Guardant Health receives FDA approval for Guardant360® CDx as companion diagnostic for Menarini Group’s ORSERDU™ for treatment of patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer CDx Approval | Guardant Health
3 | FoundationOne®Liquid CDx Receives FDA Approval as a Companion Diagnostic for Rozlytrek® (entrectinib) FDA CDx approval | Foundation Medicine
Company Announcements & Product Launches
Dr. Gary Palmer is starting off 2023 as BillionToOne’s CMO; he will be assisting in the launch of BillionToOne’s Northstar Select and Northstar Response, which are meant for patients with late stage solid tumors. Agilent has announced a collaboration with Quest Diagnostics to expand access to their ctDx FIRST LBx test; ctDx FIRST assists in identifying NSCLC patients who may benefit from KRAZATI. SOPHiA GENETICS and Memorial Sloan Kettering Cancer Center (MSK) have entered an agreement to help researchers expand analysis capabilities- MSK’s CGP sequencing test, MSK-ACCESS, will be powered by SOPHiA GENETICS’ DDM. Guardant Health also has platform news, with the launch of its AI system, Guardant Galaxy, to aid in biomarker discovery. Alithea Genomics has partnered with Lausanne University Hospital and PamGene International to develop a pan-cancer blood test for prediction of efficacy and toxicity in immune checkpoint inhibitors.
1 | BillionToOne appoints Dr. Gary Palmer as Chief Medical Officer, Oncology; Launches Northstar Select™ and Northstar Response™ Liquid Biopsy Assays for Commercial Use Product Launches | BillionToOne
2 | Agilent to Collaborate with Quest Diagnostics to Extend Access to the Agilent Resolution ctDx FIRST Liquid Biopsy Test Commercialization Partnership | Agilent, Quest Diagnostics
3 | SOPHiA GENETICS and Leading US Cancer Center Collaborate to Combine Cancer Analysis Technology for Liquid Biopsies R&D and Commercialization Partnership | SOPHiA GENETICS, Memorial Sloan Kettering Cancer Center
Clinical Trials & Study Results
Results from Natera’s CIRCULATE-Japan trial have been published, outlining the ability for Signatera to identify patients with CRC at risk of recurrence and who may benefit from adjuvant chemotherapy. Deciphera Pharmaceuticals presented results from their INTRIGUE ctDNA analysis study, which used ctDNA from patients with GIST to assess clinical benefits of QINLOCK as compared to sunitinib. Guardant Health and The Royal Marsden NHS Foundation Trust have partnered on the TRACC study, which uses ctDNA to guide chemotherapy treatment decisions in patients with early-state CRC. PetDx released a white paper demonstrating how its liquid biopsy test for dogs, OncoK9, can be used for MRD and detection of cancer recurrence in addition to screening and as a diagnostic aid. PrognomiQ recently released data about its multi-omics liquid biopsy platform in its ability to detect NSCLC as compared to non-cancer controls amongst 1,031 subjects.
1 | Natera Announces Publication of Prospective, Multi-Site CIRCULATE Study in Nature Medicine Demonstrating Signatera’s Ability to Predict Chemotherapy Benefit in Colorectal Cancer Clinical Trial Results | Natera
2 | Deciphera Pharmaceuticals Presents Results from ctDNA Analysis of INTRIGUE Phase 3 Clinical Study at the American Society of Clinical Oncology Plenary Series Session Clinical Trial Results | Deciphera Pharmaceuticals, Guardant Health
3 | Guardant Health and The Royal Marsden NHS Foundation Trust partner on highly anticipated TRACC Part C trial to use Guardant Reveal™ blood test to help guide treatment decisions in colorectal cancer Clinical Trial Collaboration | Guardant Health, The Royal Marsden NHS Foundation
M&A | VC | Private Equity | Legal
Caris Life Sciences raised $400,000,000 in debt with a senior secured term loan (SSL) from OrbiMed and Braidwell who have participated in prior funding rounds. LinusBio secured $16 million in a Series A financing led by GreatPoint Ventures and Bow Capital to further the R&D efforts for their biomarker analysis platform that uses a patient’s strand of hair. Agilent acquired Avida Biomed to integrate their target enrichment workflows for NGS that enable simultaneous profiling of genomic and DNA methylation data as well as compatibility with automated platforms.
1 | Caris Life Sciences nears $2B in total funding with $400M haul Debt Financing | Caris Life Sciences, OrbiMed, Braidwell
2 | LinusBio Raises $16 Million to Scale Growth and Deliver Tangible Outcomes Series A Funding | LinusBio, GreatPoint Ventures, Bow Capital
3 | Agilent Announces Acquisition of Avida Biomed, Developer of High-Performance NGS Target Enrichment Workflows for Cancer Research Acquisition | Agilent, Avida Biomed
Additional Sources
Clinical & Regulatory
1 | Micronoma Receives FDA Breakthrough Device Designation for OncobiotaLUNG, A Novel Liquid Biopsy Assay for Lung Carcinoma Detection FDA BDD | Micronoma
2 | Geneseeq receives CE Marks for MRD and MCED tests CE Certification | Geneseeq
Company Announcements & Product Launches
1 | Guardant Health introduces Guardant GalaxyTM suite of advanced AI analytics to enhance its portfolio of cancer tests and accelerate biomarker discovery Product Launch | Guardant Health
2 | Alithea Genomics and partners to develop a first-of-a-kind pan-cancer blood test R&D Partnership | Alithea Genomics SA, PamGene International B.V., Lausanne University Hospital
Clinical Trials & Study Results
1 | OncoK9 Liquid Biopsy Test Can Enhance Cancer Monitoring in Dogs, New Results Show Study Results | PetDx
2 | PrognomiQ's Multi-omics Liquid Biopsy Platform Demonstrates Promising Results in Early-Stage Cancer Detection of Non-Small Cell Lung Cancer Study Results | PrognomiQ
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