Liquid Biopsy | October Roundup

Highlights & Summary

October brought numerous updates in the regulatory world for Liquid Biopsy (LBx), with additional developments in partnerships, clinical findings, and fundraising.?

Featured DeciBio Insights

1 | Oncology Liquid Biopsy (LBx) Market Report 2022 - 2027 Liquid Biopsy Market Report | DeciBio Consulting

2 | New and Established Early Detection Companies Work to Solidify their Standings: This is a Race to Watch EDx Landscape 2021-2022 | DeciBio Consulting

Featured Authors: Hannah Glazier & Margaret Murray?

Clinical & Regulatory

The past month included multiple regulatory updates. Cleveland Diagnostics’ blood-based prostate cancer detection test, IsoPSA, received Medicare coverage and AMA coding. Menarini Silicon Biosystems also had news related to AMA coding; their CELLSEARCH CMMC assay and CELLSEARCH HER2 Circulating Tumor Cell (CTC-HER2) assay received CPT-PLA codes. The CELLSEARCH CMC assay serves to detect plasma cell disorders like multiple myeloma, while the CTC-HER2 assay focuses on HER2 markers. Neogenomics is working towards Medicare coverage for their RaDaR assay, which looks to monitor CRC in patients through minimal residual disease detection. However, MolDX informed Neogenomics that additional clinical evidence is necessary for Medicare coverage.?

1 | Cleveland Diagnostics Announces Favorable Medicare Local Coverage Determination and Assignment of a CPT-PLA Code for IsoPSA Reimbursement Coverage & Codes | Cleveland Diagnostics

2 | Menarini Silicon Biosystems Liquid Biopsy Tests Issued CPT-PLA Codes Reimbursement Codes | Menarini Silicon Biosystems

3 | NeoGenomics Provides Update on MoIDX Submission for CRC and RaDaR? Commercial Launch MolDX Coverage Update | NeoGenomics

Company Announcements & Product Launches

Personalis announced a collaboration with Duke University and Olink Proteomics AB to better understand resistance and immunological responses to pembrolizumab for patients with gastroesophageal cancer. Personalis’ NeXT Personal assay will be used for monitoring ctDNA levels as patients undergo therapy. Lucence also announced a partnership, though their efforts with Omnigen will support distribution of Lucence’s NGS assay, LiquidHALLMARK, in Turkey. This assay can profile 80 genes across 15 different cancers. In a similar vein, Angle announced a distribution deal for Parsortix, a tumor cell enrichment tool, with Promedeus to support the Czech market. In the world of IP, Biora Therapeutics announced the sale of multiple patents that relate to determining the origins of molecules in cell free fluids to Roche Diagnostics.?

1 | Personalis Forms Research Collaboration to Better Predict Immunotherapy Response for Gastroesophageal Cancer | Business Wire Research Collaboration | Personalis, Duke University, Olink Proteomics AB

2 | Biora Therapeutics Announces Sale of Cell-Free DNA Patent Rights Patent Family Assignment | Biora Therapeutics, Roche Diagnostics

3 | Lucence Partners with Omnigen to Distribute Cancer Blood Tests in Turkey International Distribution Partnership | Lucense, Omnigen

Clinical Trials & Study Results

Personal Genome Diagnostics (PGDx) has partnered with Johns Hopkins University for a recently announced clinical study which aims to assess the efficacy of liquid biopsy comprehensive genomic profiling for cancer treatment selection and therapy response monitoring. The trial is expected to run over roughly three years, and to enroll 150 patients. BioMark Diagnostics announced the results of a preclinical trial which show that the inhibition of SAT1, a biomarker which their assay test offers, is an effective means of sensitizing glioblastoma cells to radiation and chemotherapy.? Glioblastoma is an aggressive brain cancer which currently has very limited treatment options, and BioMark hopes these findings will prove to be a breakthrough. In a study recently published in Gynecologic Oncology, a team from the Karolinska Institute found that ctDNA load was predictive of cervical cancer characteristics and prognosis.

1 | Liquid Biopsy-informed Precision Oncology Study to Evaluate the Clinical Utility of Non-invasive Comprehensive Genomic Profiling for Cancer Treatment Selection Clinical Trial Announcement | Johns Hopkins, PGDx

2 | BioMark’s Glioblastoma Study Published in Cancers Demonstrates Inhibiting SAT1 Sensitized Cancer Cells Towards Radiation and Chemotherapy Study Results Preclinical Study Results | BioMark

3 | Circulating Cell-Free Tumor Human Papillomavirus DNA is a Promising Biomarker in Cervical Cance r Academic Study | Karolinska Institute

M&A | VC | Private Equity | Legal

Ravgen is suing major NIPT players, such as Illumina, Quest Diagnostics, and Natera, for alleged patent infringement on prenatal testing technology. In their largest win, Ravgen secured $273 million from Laboratory Corporation of America for violation of the ‘277 patent. Diagnostic solutions company DeepUII closed a $13 million financing round to bring its sepsis early detection platform to market. This product can detect more than 250 different pathogens and 15 resistance genes to generate phenotypic antimicrobial susceptibility results without positive blood culture. Oxford BioDynamics raised $10.2 million in shares, and is proposing an open offer of an additional 14.7 million new shares to qualifying stakeholders. These funds are focused towards the commercialization of EpiSwitch Cirt.

1 | Meet Ravgen, the Little-Known Company Rattling NIPTs Biggest Players in Court | GenomeWeb ) Patent Infringement, NIPT | Ravgen

2 | DeepUII Raises $13M to Bring its Sepsis Platform to Market Fundraising | DeepUII

3 | Oxford BioDynamics to Raise up to GBP12.0M? to Boost Cancer Test Commercialization Fundraising | Oxford BioDynamics

Additional Sources

Clinical & Regulatory

1 | Bluestar Genomics Receives CAP Accreditation for its Clinical Laboratory CAP Accreditation | Bluestar Genomics

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Company Announcements & Product Launches

1 | Hedera Dx Hopes to Hasten Liquid Biopsy Adoption in Europe With Streamlined Platform | Precision Oncology News ) Software Product Announcement | Hedera Dx

2 | Angle Signs Distribution Deal for Parsortix Cell Sorting System in Czech Republic European Distribution Deal | Angle, Promedeus

3 | ?OncoK9(R), the Pioneering Blood-Based Early Cancer Detection Test for Dogs, Now Available in Asia Through Asia Veterinary Diagnostics Company Announcement Global Expansion | PetDx

4 | GRAIL and Carrum Health Partner to Include Galleri as Part of Comprehensive Cancer Care Offerings to Employers Test Coverage Expansion | GRAIL, Carrum Health

Clinical Trials & Study Results

1 | Liquid Biopsies Can Detect Which Cancer Patients May be at Higher Risk of Developing Additional Blood Cancers Clinical Trial Incidental Finding | Institut Gustave Roussy

2 | Clinical Implications of Circulating Tumor DNA in Predicting the Outcome of Diffuse Large B Cell Lymphoma Patients Receiving First-Line Therapy Research Article | BMC Medicine