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Highlights & Summary  

Liquid Biopsy (LBx) continued to develop through August, featuring new collaborations as well as regulatory and financial developments.

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Featured DeciBio Insights

1 | Oncology Liquid Biopsy (LBx) Market Report 2024 – 2029 Market Report | DeciBio

2 | Advanced Therapies in Focus: A Deep Dive into the Cell & Gene Therapy Market Upcoming Webinar | DeciBio

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Clinical and Regulatory

Guardant Health was granted Japanese regulatory approval for its Guardant360 CDx blood test as a CDx for amivantamab-vmjw. The approval will allow for the identification of patients eligible for combination therapy, along with chemotherapy, in recurrent and inoperable NSCLC patients whose tumors have EGFR exon 20 insertions. Meanwhile, in the U.S., Labcorp has received FDA De Novo marketing authorization for its PGDx elio plasma focus Dx, the first kitted, pan-solid tumor LBx test on the market. The authorization builds on Labcorp’s elio tissue complete panel’s FDA approval. Telo Genomics, whose technology aims to interrogate telomere data for prognostic and diagnostic purposes, announced that it had receive CLIA certification, thereby allowing the company to offer services in the U.S.

1 | Guardant Health Japan Receives Regulatory Approval of Guardant360® CDx as Companion Diagnostic for amivantamab-vmjw to Identify Patients with Inoperable or Recurrent NSCLC Harboring EGFR exon 20 Insertion Mutations Japan Regulatory Approval | Guardant Health

2 | Labcorp Receives FDA De Novo Marketing Authorization for PGDx elio™ plasma focus Dx FDA De Novo Authorization | Labcorp

3 | Telo Genomics Receives CLIA Certification CLIA Certification | Telo Genomics

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Company Announcements & Product Launches

Imidex and Orbit Genomics announced a collaboration focused on early detection of lung cancer. Imidex’s computer vision AI and FDA 510(k) cleared VisiRad XR device has  demonstrated 83% sensitivity in detecting lung nodules as small as 6 mm in chest x-rays. Orbit Genomics’ OrbiSeq-L is a liquid biopsy assay utilizing AI to analyze repetitive DNA, and can be used to diagnose lung cancer in patients with indeterminate pulmonary nodules found through imaging. Sysmex announced it expanded its collaboration with QIAGEN in genetic testing. Sysmex will implement QIAGEN’s assays in clinical trials at Sysmex’s global network laboratories and support QIAGEN’s global services.

1 | AI-based Medical Device Company Imidex and Precision Genomix Company Orbit Genomics Form Strategic Relationship to Explore the Detection of Lung Cancer in Early Stages Strategic Partnership | Imidex, Orbit Genomics  

2 | Sysmex Expands Strategic Alliance Agreement with QIAGEN in the Field of Genetic Testing Strategic Partnership | Sysmex, QIAGEN

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Clinical Trials & Study Results

Exact Sciences announced that the first patient has joined its Multi-Cancer Early Detection (MCED) Falcon Registry Real-World Evidence (RWE) study. The study will enroll up to 25,000 patients, evaluating the clinical performance, patient and provider experience, and psychological impact of MCED testing over a five-year period. Meanwhile, an investigation by The BMJ suggested that GRAIL’s test demonstrates unsatisfactory sensitivity and data, questioning whether the current trial (and NHS’ commitment to purchase millions of tests by 2030 if Galleri fulfills certain criteria) is ethical.  

1 | Exact Sciences Announces First Patient Enrolled in its Multi-Cancer Early Detection (MCED) Falcon Registry Real-World Evidence Study First Patient Enrolled | Exact Sciences

2 | Galleri Promises to Detect Multiple Cancers—but New Evidence Casts Doubt on this much Hyped Blood Test BMJ Investigation | GRAIL

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M&A | VC | Private Equity | Legal

Personalis and Tempus AI announced an expansion of their commercial relationship around Personalis’ MRD assay. Tempus will invest approximately $36M into Personalis under the terms of Tempus accelerating its commercialization efforts over the first two years and Personalis increasing the quantity of patient samples it will accept over the corresponding period. Tempus will consequently own approximately 19.3% of Personalis’ outstanding common stock following the closing of the transactions. Universal Dx closed its Series B funding round, which will be used to advance the clinical trial of Signal-C, Universal Dx’s CRC screening blood test. The undisclosed funding is an extension of the $70M Series B round closed in November 2023.  

1 | Personalis to Receive $36M Investment from Tempus AI for MRD Test Investment | Personalis, Tempus AI

2 | Universal DX (UDX) Closes Series B Funding for Clinical Trials on Colorectal Cancer Screening Blood Test, Signal-C® Series B Funding | Universal Dx