Highlights & Summary

Liquid Biopsy (LBx) continued to develop through May, featuring new CE-IVD and FDA approvals, research and commercialization collaborations, and new trial launches and study results.

Clinical & Regulatory

CE-IVD and FDA approvals dominate clinical and regulatory news this May with Angle, Genomic Testing Cooperative (GTC), SeekIn, and Genes2Me included. Angle’s Parsortix was granted FDA clearance to harvest cancer cells in blood samples from metastatic breast cancer patients. GTC gained CE-IVD approval for their Hematology Profile Plus and their Solid Tumor Profile Plus. The Hematology Profile Plus provides data to aid in therapy selection and can also diagnose and/or classify myeloid and lymphoid neoplasms. The Sold Tumor Profile Plus produces data on mutations, fusion genes, and homologous recombination deficiency (HRD). While liquid biopsy certainly has use in diagnosis and therapy selection, SeekIn made progress for monitoring applications. The SeekInClarity Cancer Treatment Response Monitoring Kit gained CE approval ⁠— this kit monitors treatment across various cancers using a molecular tumor burden (MTB) algorithm to oversee therapy efficacy. 

Additional highlights this month relate to payor coverage with Tempus, Grail, and Myriad all furthering efforts to expand access to cancer testing. Immunovia also improved accessibility by gaining clinical laboratory permits for 48 states to increase use of IMMray, which aids in early detection of pancreatic cancer.

1 | ANGLE receives FDA clearance for Parsortix
FDA Clearance | Angle PLC
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2 | Genomic Testing Cooperative Hematology Profile Plus, Solid Tumor Profile Plus, and Liquid Biopsy Profiles Receive CE-IVD Mark
CE-IVD Approval | Genomic Testing Cooperative
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3 | SeekIn Receives CE Mark Approval for SeekInClarity™ Cancer Treatment Response Monitoring Kit
CE Approval | SeekIn

Company Announcements & Product Launches

Research and commercialization partnerships were the major themes of May’s company announcements. Datar Cancer Genetics plans to bring their cancer screening and diagnostic portfolio ⁠⁠— Trucheck™ Pragma and Cancertrack™ solutions from their cancer screening and diagnostic portfolio to the U.S. and Vietnam through Artemis DNA’s laboratory networks. CorePath Laboratories and Cizzle Biotechnologies as well as Hitachi High-Tech and Invivoscribe are entering into strategic partnerships for the development and commercialization of novel cancer detection technologies. Delfi Diagnostics entered into a broad research agreement with Memorial Sloan Kettering Cancer Center to establish a collaboration framework to further Delfi’s early cancer detection platforms. Interpace Diagnostics’ custom NGS panels will utilize Twist Bioscience’s chemistries for library preparation and hybridization capture automation on Miroculus’s digital microfluidics (DMF) instrument, the Miro Canvas.

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1 | Datar Cancer Genetics Announces Foray Into the United States with a $250M Contract to Offer Pioneering Cancer Detection Liquid Biopsies
Lab Distribution Deal | Datar Cancer Genetics, Artemis DNA
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2 | CorePath Laboratories Announces Partnership with Cizzle Biotechnology to Develop Simple Blood Test for Early Lung Cancer Detection
Commercialization Partnership | CorePath Laboratories, Cizzle Biotechnology
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3 | Delfi Diagnostics Enters into Broad Research Agreement with Top U.S. Cancer Center
Broad Research Agreement | Delfi Diagnostics, Memorial Sloan Kettering Cancer Center

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Clinical Trials & Study Results

Observational and validation studies showcased new assays and approaches this month. Adela launched a >5,200 patient, prospective, observational clinical trial to train and validate a bisulfite-free genome-wide methylome enrichment assay, or cfMeDIP-seq, to detect multiple cancer indications for early detection and MRD. Predicine announced results from a study led by Bristol Myers Squibb that showed the 600-gene PredicineATLAS assay outperformed other ctDNA NGS tests, delivering the highest sensitivity and accuracy at 10 ng DNA input and demonstrating 100% specificity (i.e., no false positives). Lucence also announced a validation study publication for their LiquidHALLMARK ctDNA assay with analytical validation, showing a sensitivity of 99.38% for point mutations and 95.83% for insertions / deletions at 0.1% variant allele frequency (VAF).

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1 | cfMeDIP-seq Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (CAMPERR)
Clinical Trial Launch | Adela, Inc.
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2 | Predicine Liquid Biopsy Outperforms Four other Leading ctDNA NGS Tests in a Study Led by Bristol Myers Squibb
Validation Study Results | Predicine, Bristol Myers Squibb
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3 | Lucence Announces Publication of Validation Study for LiquidHALLMARK ctDNA Liquid Biopsy Assay
Validation Study Results | Lucence

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M&A | VC | Private Equity | Legal

Guardant and Illumina’s lawsuit continues, with Guardant filing to change the venue or even dismiss the case. Some companies are continuing to raise money. OncoHost raised $35 million in Series C financing to launch its PROphet blood test used for early identification of responsiveness to cancer therapy. Finally, Progenity transferred its discovery-stage biochemical and bioinformatics technologies, including single-molecule detection, to newly formed Enumera Molecular Inc. for development and commercialization. These technologies are designed to enable next-generation rapid, low-cost assessment of biomolecules through liquid biopsy.

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1 | Guardant Health Files Motions to Dismiss, Change Venue in Illumina Patent Lawsuit
IP Lawsuit Update | Guardant Health, Illumina
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2 | OncoHost nabs $35M in funding round
Series C Funding | OncoHost, Alive Israel HealthTech
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3 | Progenity Announces Successful Transfer of Liquid Biopsy Technologies
Acquisition, Series A Funding | Enumera Molecular, Progenity, Arboretum Ventures

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Clinical & Regulatory
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Additional Sources

4 | Genes2Me Obtains CE Marking for Clinical Sequencing Panels
CE Approval | Genes2Me

5 | Tempus Announces Agreement With the United States Department of Veterans Affairs National Precision Oncology Program To Expand Access to Genomic Testing for Veterans With Cancer
Payor Coverage | Tempus, Department of Veterans Affairs

6 | Munich Re Life US and GRAIL Enter Partnership to Promote Early Cancer Detection
Payor Coverage | GRAIL, Munich Re Life US

7 | Myriad Genetics Expands Partnership with Intermountain Precision Genomics to Add Liquid Biopsy Therapy Selection Offering to Portfolio of Precise™ Oncology Solutions
Payor Coverage | Myriad Genetics, Intermountain Precision Genomics

8 | Immunovia, Inc. market access increases when achieving Clinical Laboratory Permits from Pennsylvania and Maryland Departments of Health making IMMray™ PanCan-d test available in 48 US states
Clinical Laboratory Expansion | Immunovia, Inc.

Company Announcements & Product Launches

Additional Sources

4 | Hitachi High-Tech and Invivoscribe partner to advance molecular diagnostics
Research and Commercialization Partnership | Hitachi High-Tech Corporation, Invivoscribe, Inc.

5 | Miroculus to Optimize Automated Next Generation Sequencing Library Preparation with Interpace Diagnostics and Twist Bioscience
Commercial Research Collaboration | Interpace Diagnostics, Twist Biosciences, Microculus

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Clinical Trials & Study Results

Additional Sources

4 | Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer
Clinical Trial Launch | Inova Health Care Services, Natera

5 | Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors
Clinical Trial Launch | InSightec

6 | Angle PLC - Prostate Cancer UK Funds New Study Using Parsortix
Clinical Trial Announcement | Angle PLC, Barts Cancer Institute

7 | InterVenn to Present New Clinical Data at ASCO 2022 on Using Glycoproteomics as Powerful Liquid Biopsy Tests for Early Detection of Cancer and Prediction of Checkpoint Inhibitor Treatment Benefit
Validation Study Announcement | InterVenn

8 | Illumina and Allegheny Health Network to Assess In-House Comprehensive Cancer Genomic Profiling to Enhance Patient Care
Clinical Research Collaboration | Illumina, Allegheny Health Network

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M&A | VC | Private Equity | Legal

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Additional Sources

‍4 | BioMark Diagnostics Raises C$1.5M to Commercialize Lung Cancer Liquid Biopsy Test
Private Funding | BioMark Diagnostics

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