Liquid Biopsy | February Roundup

March 9, 2023
Newsletter Update
Clinical Diagnostics

Highlights & Summary

Though not a leap year, liquid biopsy (LBx) saw several steps forward in February, with coverage decisions from Medicare and commercial payors as well as multiple collaborations.

Featured DeciBio Insights

1 | MRD Ad Board Report | 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

Natera received Medicare coverage for their Signatera MRD test in monitoring breast cancer as well as their first commercial payor coverage through Blue Shield of California for a pan-cancer policy and Blue Cross and Blue Shield of Louisiana for a multi-cancer policy (in CRC, bladder, IO monitoring) following prior Medicare coverage. FoundationMedicine also received commercial coverage for FoundationOneCDx and FoundationOneLiquidCDx (in advanced breast cancer, metastatic NSCLC, recurrent ovarian cancer, and metastatic castrate-resistant prostate cancer) through UnitedHealthcare, effective in April. Lucense received Medicare reimbursement for their LiquidHALLMARK assay in lung cancer and John Hancock expanded access to Galleri by GRAIL to eligible life insurance customers in their John Hancock Vitality PLUS program.

1 | Medicare to Cover Natera’s Signatera MRD Test in Breast Cancer MRD Medicare Coverage | Natera

2 | UnitedHealthcare Provides Commercial Coverage for FoundationOne®CDx and FoundationOne®Liquid CDx in Multiple Companion Diagnostic Indications | Business Wire CDx Commercial Coverage | Foundation Medicine, UnitedHealthCare

3 | Lucence Announces Medicare Reimbursement Decision for LiquidHALLMARK® Assay in Lung Cancer | Business Wire Medicare Coverage | Lucense

Company Announcements & Product Launches

Guardant Health and AnHeart Therapeutics are collaborating on regulatory approvals for Guardant360 and Guardant360TissueNext assays to be used as companion diagnostics for taletrectinib for both the US and the EU. Last year, AnHeart received the US FDA Breakthrough Therapy designation for taletrectinib for ROS1 positive NSCLC patients. Personalis and Moderna signed an agreement to continue to use Personalis’ NeXT Platform in clinical studies that evaluate Moderna and Merck’s cancer vaccine: mRNA-4157/V940. Tempus and Actuate Therapeutics announced a multi-omics collaboration, where Tempus’ xF+ liquid biopsy and RUO DNA methylation tests will be used to validate biomarker profiles to determine which patients may benefit from treatment with Actuate Therapeutics’ elraglusib. Preliminary data showing that Neogenomics’ RADAR MRD test could help inform treatment decisions for those with bladder cancer means that this could be a future testing indication. Euformatics, ViennaLab Diagnostics, and Oncompass Medicine, will be working together to research and develop an economically sustainable liquid biopsy diagnostics solution for an EU buyer consortium that includes high profile hospitals. Synergy Oncology will be using SOPHiA GENETICS’ SOPHiA DDM for Hereditary Cancers Solution to launch Totality, an end-to-end tumor profiling solution to help inform research and patient care. Epigenomics is stopping sales for their Epi proColon cancer test, a blood based colorectal cancer screening test; this test did not receive CMS coverage in 2021, but company efforts to restructure may allow for a pathway to complete studies for regulatory approval. 

1 | Guardant Health and AnHeart Therapeutics Announce Collaboration to Develop Guardant360® CDx and Guardant360 TissueNext™ as Companion Diagnostics for Taletrectinib in Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer CDx Collaboration | Guardant Health, AnHeart Therapeutics

2 | Personalis and Moderna Sign New Agreement to Leverage NeXT Platform™ in Personalized mRNA Cancer Vaccine Clinical Trials Clinical Study Collaboration | Personalis, Moderna

3 | Tempus Announces New Multi-omics Collaboration with Actuate Therapeutics R&D Collaboration | Tempus, Actuate Therapeutics

Clinical Trials & Study Results

The Center for Asian Health Equity - University of Chicago, will be using Guardant Health’s Shield blood test to better understand patient and provider preferences for cancer screenings. Patients at Federally Qualified Health Centers who fail to complete guideline recommended screenings will have the option to use the Shield Blood test. Cancer screening is not only applicable to humans, but can be used in dogs as well - PetDx announced results indicating that their multiple cancer early detection liquid biopsy test, OncoK9, should broadly be used on dogs once they turn 7. The Children’s Hospital of Los Angeles this month released a study to understand the accuracy of their proprietary LBx assay, OncoKids, on multiple tumor types, including ewing’s sarcoma and alveolar rhabdomyosarcoma. A research team at Australia’s University of Melbourne's Peter MacCallum Cancer Centre, joined by American and Canadian researchers as well, has found that end-stage cases of some ovarian cancers are marked by homologous recombination DNA repair defects, corresponding to treatment resistance. In ctDNA experiments for a small population, investigators for that ctDNA sequencing found HR-related mutation reversions for some patients at their first-line chemotherapy treatment. Researchers at Stanford University published a study detailing the ability for ctDNA to detect multiple myeloma, with findings supporting that it may better capture spatial tumor heterogeneity and understanding response to CAR-T cell therapy. 

1 | Guardant Health Initiates New Study to Examine the Impact of Shield™ Blood Test to Increase Screening Compliance for Colorectal Cancer Study Launch | Guardant Health

2 | Dogs Should Be Screened for Cancer Beginning at Age 7, as Early as Age 4 for Certain Breeds, PetDx Study Shows Study Results | PetDx

3 | Combined low-pass whole genome and targeted sequencing in liquid biopsies for pediatric solid tumors Study Results | Children’s Hospital Los Angeles

M&A | VC | Private Equity | Legal

Dxcover Limited raised $11.9 million in Series A and grant financing to support their liquid biopsy platform for the detection of various early-stage cancers. Dxcover’s platform uses infrared spectroscopy in the analysis of blood samples, paired with AI, to detect disease. QuartzBio, a segment of Precision for Medicine, has acquired SolveBio. SolveBio offers data management services, which will be integrated with QuartsBio’s offerings to help support clinical sample and biomarker data management. 

1 | Dxcover Raises $11.9m in Series A and Grant Funding to Accelerate Liquid Biopsy to Market | Business Wire Series A Funding | Dxcover Limited

2 | QuartzBio, a Part of Precision for Medicine, Acquires SolveBio and Expands Software-as-a-Service (SaaS) Data Management Solutions for Clinical Research & Development (R&D) Acquisition | QuartzBio, SolveBio

Additional Sources

Clinical & Regulatory

1 | Natera Announces Commercial Payor Coverage for Signatera MRD Commercial Coverage | Natera

2 | John Hancock expands access to Galleri®, GRAIL's breakthrough cancer screening technology Expanded Access | GRAIL, John Hancock

Company Announcements & Product Launches

1 | NeoGenomics Eyes Bladder Cancer as Future Indication for Radar MRD Test New Indication | NeoGenomics

2 | Euformatics, in partnership with ViennaLab Diagnostics and Oncompass Medicine, awarded a contract to research and develop an end-to-end liquid biopsy solution for eight leading European oncology centers  R&D, Commercialization Partnership | Euformatics, ViennaLab Diagnostic, Oncompass Medicine

3 | Synergy Laboratories Taps SOPHiA GENETICS Technology for New Cancer Profiling Solution Commercialization Partnership | Synergy Laboratories, SOPHiA GENETICS

4 | Guardant Health Reports Fourth Quarter and Full Year 2022 Financial Results and Provides 2023 Outlook Company Financial Update | Guardant Health

5 | Epigenomics Announces Product Line Cancellation in Restructuring Product Structure Changes | Epigenomics

Clinical Trials & Study Results

1 | End-Stage Ovarian Cancer Marked by Rampant Treatment Resistance, Multiple Clones Study Results | University of Melbourne's Peter MacCallum Cancer Centre

2 | Liquid biopsy predicts response to CAR-T for multiple myeloma Study Results | Stanford University School of Medicine

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