Highlights & Summary

Liquid Biopsy (LBx) had an active December, featuring distribution deals and debuted products as well as many trial and study results.

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Featured DeciBio Insights

1 | Spatial Biology Market Report - First Edition: 2022 | Market Report | Andrew Aijian,  Cameron Braverman, Rebecca Burnham, Colin Enderlein

2 | Liquid Biopsy Early Cancer Detection Diagnostics The Current Landscape | Guest Feature | Andrew Aijian  

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Clinical & Regulatory

Agilent Technologies and Qiagen gain FDA approval of their companion diagnostics assays for advanced NSCLC, and will be used to identify patients who are likely to benefit from Mirati Therapeutics’ drug, Krazati. 

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1 | FDA Approves ctDx FIRST Companion Diagnostic for KRAS G12C-Mutated NSCLC FDA Approvals | Agilent, Qiagen

Company Announcements & Product Launches

Guardant Health partners with AstraZeneca for development of Guardant360 to identify breast cancer patients for the phase III trial of Camizestrant. 4D Lifetec partners with the Molecular Diagnostics Group to develop 4D Lifetec’s early cancer assays for lung, breast, prostate, and colon cancers. Guardant Health collaborates with Susan G. Komen to generate clinical data for the Guarant Reveal MRD assay in early-stage breast cancer. Bluestar Genomics rebrands as ClearNote Health with new distribution deals. Oncocyte will lay off 40% of workforce, as well as sell its DetermaRx lung cancer test and 70% of stake in Razor Genomics as part of company reorganization.

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1 | Guardant Health Announces Collaboration With AstraZeneca to Develop Companion Diagnostic to Identify Patients with ESR1-mutated Metastatic Breast Cancer CDx Partnership | Guardant Health, AstraZeneca

2 | 4D Lifetec and Molecular Diagnostics Group Announce Strategic Partnership to Further Industrialization of 4D Lifetest Liquid Biopsy Assay R&D Partnership | 4D Lifetec, Molecular Diagnostics Group

3 | Guardant Health and Susan G. Komen Partner to Develop Clinical Studies to Identify Early-Stage Breast Cancer Patients Who May Benefit from Additional Monitoring or Therapy Research Collaboration | Guardant Health, Susan G. Komen

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Clinical Trials & Study Results

Guardant Health announces positive results from the ECLIPSE study, with the test demonstrating 83% sensitivity and 90% specificity for the detection of CRC. Bluestar Genomics collaborates with Thermo Fisher Scientific for a prospective trial (NODMED) to evaluate its epigenomic early cancer detection test for pancreatic cancer in Type 2 Diabetes patients. A preprint study from the Ontario Institute for Cancer Research provides early support for a multiomic, blood-based early cancer diagnostic in Li-Fraumeni Syndrome patients, who are at elevated risk for developing diverse tumors.

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1 | Guardant Health announces positive results from pivotal ECLIPSE study evaluating a blood test for the detection of colorectal cancer Clinical Trial Results (NCT04136002) | Guardant Health

2 | Bluestar Genomics Initiates One of the Largest Clinical Trials for Early Detection of Pancreatic Cancer Clinical Trial Launch (NCT05188586) | Bluestar Genomics (ClearNote Health), Thermo Fisher Scientific

3 | Cancer Early Detection Shows Promise in New Li-Fraumeni Syndrome Data Study Results | Ontario Institute for Cancer Research‍

M&A | VC | Private Equity | Legal

Invitae sells portfolio of Archer NGS assays to Integrated DNA Technologies (IDT) for $48M as part of portfolio optimization efforts. Natera files second patent infringement lawsuit against Inivata over their use of patented technology to develop the Radar MRD assay. BillionToOne raises $83.5M in funding to develop and commercialize prenatal screening tests, and demonstrates clinical performance of the Unity NIPT test. Numares Health secures €40M in financing to commercialize its automated Axinon System for in vitro diagnostics. The European Commission issues a Statement of Objections, including divestment and transitional measures, to unwind Illumina’s blocked acquisition of GRAIL. Prenetics Global acquires majority stake in in ACT Genomics to accelerate utilization of genetic information through a cancer patient’s journey.

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1 | Integrated DNA Technologies Acquires ArcherDx Next Generation Sequencing Research Assays from Invitae Corporation Technology Transfer | Integrated DNA Technologies (IDT), Invitae

2 | Natera Files Second Patent Infringement Suit Against NeoGenomics Subsidiary Inivata Patent Infringement Suit | Natera, Inivata, NeoGenomics

3 | BillionToOne Announces $48.5M Additional Capital Raise and $35M Upsized Term Loan Facility, Demonstrating Investor and Lender Confidence in the Company's Rapid Growth Follow-On Funding | BillionToOne

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Additional Sources

Company Announcements & Product Launches

1 | Bluestar Genomics Advances to Commercial Phase, Rebrands as ClearNote Health Rebranding | ClearNote Health (Bluestar Genomics)

2 | Oncocyte Cuts 40% of Staff, To Sell 70% Stake in Subsidiary Company Divestiture | Oncocyte, Razor Genomics

M&A | VC | Private Equity | Legal

1 | Germany: EIB Provides €20 Million in Financing to Innovative Diagnostics Developer Numares Private Funding | Numares Health, European Investment Bank

2 | Mergers: The Commission adopts a Statement of Objections outlining measures to unwind Illumina's blocked acquisition of GRAIL Statement of Objections Adoption | European Commission, Illumina, GRAIL

3 | Prenetics Acquiring Majority Stake in ACT Genomics, Expanding Position in Cancer Genetics, Precision Oncology Majority Stake Acquisition | Prenetics Global, ACT Genomics