Highlights & Summary
Liquid Biopsy (LBx) continued to develop through April, featuring new clinical and research collaborations as well as trial launches and study results.
Featured DeciBio Insights
- Liquid Biopsy for Dogs: OncoK9 and the CANDiD Study Q&A with Daniel Grosu of PetDx
Clinical Validation Study Results | PetDx
- The Future of Proteomics: Seer’s Origins & the Proteograph’s Commercial Launch Q&A with Omid Farokhzad
Commercial Launch | SEER
Clinical & Regulatory
- Texas Oncology Announces Collaboration to Provide More Cancer Patients with Access to Liquid Biopsy Testing from Foundation Medicine | Business Wire
Provider Test Offering | Texas Oncology, Foundation Medicine
- Guardant Health Announces Partnership with Epic to Streamline Access to Company’s Broad Portfolio of Cancer Tests
EHR Integration Partnership | Guardant Health, Epic
- SeekIn Receives CE Mark Approval for LeukoPrint® Molecular Karyotyping Test
CE Approval | SeekIn
Company Announcements & Product Launches
- C2i Genomics Launches C2inform MRD Test to Bring Distributed Cancer Monitoring to Cancer Centers Across Europe | WebWire
Commercial Launch, CE Certification | C2i Genomics
- Singlera Genomics announces research collaboration with Astellas Pharma pursuing methylation-based tools to better understand biological reactions to pharmaceuticals
Study Partnership | Singlera Genomics, Astellas
- Stilla and Promega Announce Co-Marketing Agreement to Offer Complete Digital PCR Workflow Solution
Partnership | Stilla Technologies, Promeg
Clinical Trials & Study Results
- Multi-canceR Early-detection Test in Asymptomatic Individuals (PREVENT)
Clinical Trial Launch | Burning Rock
- Development of Free DNA Multi-target Methylated PCR for Auxiliary Diagnosis of Gastric Cancer
Clinical Trial Launch | Singlera Genomics, Fudan University
- Exai Bio Demonstrates Its Unique RNA-based Liquid Biopsy Strategy for Early Detection and Monitoring of Multiple Cancers
Validation Study Results | Exai Bio
M&A | VC | Private Equity | Legal
- Fulgent Genetics Agrees to Acquire Inform Diagnostics and Provides Preliminary First Quarter Revenue Results
Acquisition | Fulgent Genetics, Inform Diagnostics
- Diadem Announces First Closing of €10 Million Equity Financing for Its AlzoSure® Predict Prognostic Blood Test for Alzheimer's Disease
Equity Financing | Diadem
Clinical & Regulatory
Texas Oncology and Foundation Medicine have partnered to expand access to FoundationOne Liquid CDx for Texas Oncology care teams. This FDA-approved test can help with treatment planning for solid tumors. Lori Brisbin, VP for Texas Oncology's Precision Medicine Program, notes how the test will be of critical importance for NSCLC patients, who often lack tissue available for testing.
Guardant Health announced a partnership with Epic to integrate Guardant’s portfolio of cancer tests with Epic’s comprehensive health record to provide health systems, community healthcare providers and retail health clinics with direct ordering access and results delivery to Guardant Health blood tests. Guardant Health tests can be ordered electronically within Epic once integration is complete in Q3 to provide an easier and more efficient workflow for clinicians.
3 | SeekIn Receives CE Mark Approval for LeukoPrint® Molecular Karyotyping Test
SeekIn announced the awarding of a CE (Conformité Européenne) Mark for its LeukoPrint Molecular Karyotyping Kit for the diagnosis, molecular subtyping, prognostic stratification and treatment response monitoring of leukemia patients and other hematological malignancies. LeukoPrint detects copy number aberration (CNA) patterns in patients based on shallow whole-genome sequencing (sWGS) of cell-free DNA (cfDNA) and/or bone marrow cells in combination with conventional cytogenetics technologies.
Company Announcements & Product Launches
C2i Genomics has launched its C2inform minimal residual disease (MRD) test across Europe, following CE-IVD marking for the EU and the UK. Through applying whole-genome sequencing (WGS) and artificial intelligence to a blood sample, C2inform allows for cancer detection, monitoring, and therapeutic evaluation. At the AACR 2022, C2i will present performance of C2inform on studies of 3,000 plasma samples from around the world, and across multiple cancer types, including: CRC, bladder, lung, and glioblastoma. In addition to these services, the test also provides a streamlined process for use across pathology labs and genomic cancer labs. It incorporates the C2intelligence cloud-based platform, a software-as-a-service (SaaS) efort to simplify WG data management and interpretation for NovaSeq users.
Singlera announces a research collaboration with Astellas Pharma to design mTitan-based assays that interrogate rare circulating cfDNA methylation signals to aid in Astellas’ preclinical drug development pipeline. The mTitan platform has previously been used for cancer early detection and this collaboration seeks to expand its use to studying biological responses during drug treatment for development of effective therapies for patients, potentially for eventual use as a companion diagnostic.
3 | Stilla and Promega Announce Co-Marketing Agreement to Offer Complete Digital PCR Workflow Solution
Stilla Technologies and Promega Corporation announced a co-marketing agreement to offer an optimized workflow for a wide range of applications including liquid biopsy and infectious disease assays by combining sample preparation with the Maxwell systems and digital PCR (dPCR) on the 6-color naica system. The partners presented data for the liquid biopsy workflow at AACR (American Association for Cancer Research) 2022 (Poster #527 / 2).
Additional Sources
4 | Caris Life Sciences Announces Continued Growth and Investment with Opening of New Liquid Biopsy Laboratory Facility
Facilities Expansion | Caris Life Sciences
5 | Predicine to Attend 2022 AACR Conference in New Orleans to Highlight the Launch of PredicineBEACON™, a Novel, Tissue-agnostic, Actionable Assay for Minimal Residual Disease (MRD) Detection and the Recent Publication of Several Studies in Genitourinary (GU) Cancers
Product Launch | Predicine
6 | GC Genome Presents AI-Based Liquid Biopsy at the American Association for Cancer Research (AACR) Annual Meeting 2022
Product Announcement | GC Genome
7 | NeoGenomics Inc. Announces Partnership with Lilly for Lung Cancer Sponsored Testing Program Utilizing the NeoTYPE(R) DNA and RNA Assay
Clinical Partnership | NeoGenomics, Eli Lilly
8 | BIOCAPTIVA Appoints Alison Williamson as Chief Financial Officer and Board Director C-Suite and Board Appointment | BIOCAPTIVA
Clinical Trials & Study Results
1 | Multi-canceR Early-detection Test in Asymptomatic Individuals (PREVENT)
PREVENT is a prospective study that evaluates performance of Burning Rock’s OverC multi-cancer detection blood test in 12,500 patients. Participants will be followed for 5 years from their date of enrollment into the trial. Primary outcome measures of the study will look at the clinical stages of cancer for patients diagnosed with cancer via the multi-cancer detection blood test, in addition to test characteristics like the sensitivity, specificity, PPV, and NPV for the test. The study will be beginning early May 2022, with primary and secondary completion dates in 2024 and 2028 respectively.
2 | Development of Free DNA Multi-target Methylated PCR for Auxiliary Diagnosis of Gastric Cancer
This observational study on early gastric cancer screening explores the clinical diagnostic performance of multi-target PCR detection of cfDNA methylation. The study is expected to enroll 1240 participants and primary outcome measures include sensitivity and specificity of methylation detection in gastric cancer, comparison of polygene methylation detection and other serological detection methods in gastric cancer, and screening of genetic targets for kit development.
Exai Bio presented validation study data at AACR 2022 (poster 3353) on the performance of its proprietary orphan non-coding RNAs (oncRNAs) portfolio and artificial intelligence (AI) profiling technology to accurately detect the diverse tissue-of-origins (TOO) of six cancer types (breast, colorectal, gastric, kidney, liver, and lung). The study analyzed over 10,000 samples from The Cancer Genome Atlas (TCGA) against Exai Bio’s proprietary library of more than 250,000 novel oncRNAs and detected TOO with high accuracy (>91%) in each IndivuType cohort. The RNA-based liquid biopsy diagnostics platform plans to be initially utilized for early cancer detection (EDx) and minimal disease monitoring (MRD).
Additional Sources
4 | Guardant Health, Exact Sciences Make Progress on Multi-Cancer Detection Tests Validation Study Results | Guardant Health, Exact Sciences
5 | Natera Publishes VALID Study Results for Prospera Lung dd-cfDNA Transplant Rejection Assessment Test Validation Study Results | Natera
6 | Publication in Clinical and Translational Medicine Demonstrates Mutation Capsule™'s potential in MRD Assay Developments - Bloomberg Validation Study Results | Genetron Health
7 | FREENOME AND MERCK KGAA, DARMSTADT, GERMANY TO PRESENT DATA ON COMBINATION OF MULTIOMICS PROFILING AND COMPUTATIONAL MODELING AT AACR ANNUAL MEETING Validation Study Results | Freenome, Merck KGaA
8 | Kronos Bio Presents Preclinical Data on Oral CDK9 Inhibitor KB-0742, Providing Additional Evidence of Potential Efficacy in MYC-Amplified and Transcriptionally Addicted Tumors at AACR Validation Study Results | Kronos Bio
9 | Hummingbird Diagnostics Announces Publication of Study on the Utility of miRisk, a Blood-based microRNA Analysis, to Predict Overall Survival for Advanced Non-Small Cell Lung Cancer in npj Precision Oncology | Business Wire Validation Study Results, Product Announcement | Hummingbird Diagnostics
M&A | VC | Private Equity | Legal
Fulgent Genetics, Inc., is entering an agreement to acquire Inform Diagnostics. Fulgent is a technology-based genetic testing company, while Inform Diagnostics is an independent pathology laboratory. Fulgent will acquire Inform Diagnostics for $170 million during the secondary quarter of 2022 (subject to change). Fulgent aims to expand its test menu and its geographic access, as shown by its upcoming acquisition. With acquiring Inform Diagnostics, Fulgent will pursue additional developments in dermatopathology, hematopathology, neuropathology, urologic pathology, breast pathology, and GI pathology. The acquisition will reflect higher expectations for core revenue for Fulgent in 2022, which has shifted from $120 million to $175 million.
Diadem SpA announced first closing of a 10 million euro equity financing for AlzoSure Predict, the first blood-based test for early prediction of Alzheimer’s disease. The new funding will aid in further global commercialization and clinical validation of the test, beyond the CE-IVD mark and FDA Breakthrough Device designation already received.
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