Newsletter Update

Liquid Biopsy | June Roundup

July 11, 2022
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Highlights & Summary

Liquid Biopsy (LBx) in June was spearheaded by novel company partnerships and product launches as well as clinical trial launches and validation study result updates.

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Clinical & Regulatory

New clinical and regulatory partnerships in June aim to increase accessibility and utilization of LBx diagnostics in clinical settings. Tempus partnered with Eli Lilly to provide more comprehensive access to genomic testing for advanced metastatic non-small cell lung cancer (NSCLC) patients. This collaboration aims to increase accessibility to biomarker testing by providing physicians with Tempus’s xT broad-panel genomic sequencing assay or xF liquid biopsy. PetDx and Antech Diagnostics announced their agreement to expand OncoK9® access to all Antech customers across North America. OncoK9 is a pioneering multi-cancer early detection test for dogs used as preventative care and an aid-in-diagnosis tool. Additionally, Karius announced a partnership with Capstone Health Alliance expanding Karius Test access to over 265 Capstone member hospitals across the U.S. This non-invasive metagenomic infectious disease test can detect over 1,000 pathogens from a single blood sample.

1 | Tempus Announces Sequencing Collaboration With Lilly to Expand Access to Genomic Testing
Clinical Offering Partnership | Tempus, Eli Lilly

2 | Antech® Diagnostics and PetDx® Expand Access to OncoK9®, the Multi-Cancer Early Detection Test for Dogs
Clinical Offering Partnership | PetDx, Antech

3 | Karius® Partners with Capstone Health Alliance to Widen Patient Access to Liquid Biopsy Test for Infectious Diseases 
Clinical Supply Partnership | Karius, Capstone Health Alliance

Company Announcements & Product Launches

Company announcements and product launches in June centered on CDx deals and the incorporation of novel technologies to enhance detection. Caris Life Sciences debuted Caris Assure, a whole exome/transcriptome blood assay that includes both DNA and RNA coverage across somatic tumor, somatic CHIP, and germline alterations. GRAIL and AstraZeneca as well as Foundation Medicine and Arvinas entered broad strategic collaborations for the development and commercialization of companion diagnostic (CDx) assays to accompany AstraZeneca and Arvinas therapies, respectively. Berry Oncology’s early multi-cancer screening product, HIFI Pan-Cancer Screening, utilizes WGS of cfDNA for multiple cancer types. QIAGEN combined forces with Sysmex Inostics to accelerate global companion diagnostic access by expediting clinical trial timelines. Dxcover’s launch of the Dxcover® platform aims to enable faster sample analysis by leveraging Attenuated Total Reflectance Fourier Transform Infrared (ATR-FTIR) spectroscopy. A partnership between HALO Diagnostics and IncellDx seeks to drive early detection and precision diagnostics for urogenital cancers.

1 | Caris Life Sciences Introduces the Caris Assure™ Liquid Biopsy Assay at ASCO 2022
Product Launch | Caris Life Sciences

2 | GRAIL Announces Strategic Collaboration with AstraZeneca to Develop Companion Diagnostic Tests to Enable the Treatment of Early-Stage Cancer
CDx Partnership
| Grail, AstraZeneca

3 | Foundation Medicine Announces Strategic Collaboration with Arvinas
CDx Partnership | FMI, Arvinas

Clinical Trials & Study Results

June was packed with international clinical trial launches and study results updates focusing on the emerging areas of early detection (EDx), minimal residual disease (MRD), and novel technologies! Singlera Genomics partnered with various academic collaborators in China including Fudan University, AstraZeneca initiated multiple LBx-based trials with pharmaceutical and academic partners such as Eli Lilly and Dana Farber Cancer Institute, while University Health Network, Toronto sponsored multiple trials with a novel ultrasound-enabled LBx method for brain tumors. Validation study results were published by Natera’s Signatera across multiple indications, Angle PLC for circulating tumor cell (CTC)-based Pasortix in SCLC and pancreatic cancer, Memorial Sloan Kettering in MRD, and Creatv Bio in their CTC-based metastatic breast cancer (mBC) detection.

1 | Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers
Clinical Trial Launch | Singlera Genomics, Fudan University

2 | Circulating tumor DNA (ctDNA) and late recurrence in high-risk, hormone receptor–positive, HER2-negative breast cancer (CHiRP)
Study Results | Invitae, Dana Farber Cancer Institute, AstraZeneca

3 | Natera to Present New Signatera™ Clinical Data Across Multiple Cancer Types at the 2022 ASCO Annual Meeting
Study Results | Signatera 

M&A | VC | Private Equity | Legal

Early this June in M&A, VC, and private equity activity, NuProbe, a molecular diagnostics and genomics company, closed with $50M in fundraising. These efforts were led by a multitude of investors, including AstraZeneca, Panlin Capital, CR-CP Life Science Fund, Sequoia Capital China, and Biotrack Capital. The funds will be used to develop new technologies and help introduce more IVD clinical studies and regulatory packages. Also this month, Exact Sciences purchased OmicEra for $15M to support Exact Sciences’ biomarker discovery through the use of OmicEra’s mass-spectrometry-based proteomics technologies. Epic Sciences closed $43 million in Series F financing in part to aid the launch of their DefineMBC liquid biopsy solution, which informs features about metastatic breast cancer such as detecting CTCs, assessing proteins (e.g., HER2), and calculating microsatellite instability (MSI). 

1 | NuProbe Closes $50M in New Fundraising
Series B Financing | NuProbe, AZN-CICC, CR-CP, Panlin Capital

2 | Exact Sciences buys German biotech startup OmicEra Diagnostics for roughly $15M
Acquisition | Exact Sciences, OmicEra

Series F Financing | Epic Sciences

Additional Sources

Company Announcements & Product Launches

4 | Berry Oncology launches HIFI Pan-Cancer Screening, a multi-cancer early screening product for detecting six high-risk cancers at one time
Product Launch | Berry Oncology  

5 | Sysmex Inostics & QIAGEN Highlight Cancer Companion Diagnostics Alliance at ASCO 2022
CDx Partnership | Sysmex Inostics, QIAGEN

6 | Dxcover Launches Infrared Platform: Ground-Breaking Technology for Faster Sample Analysis
Product Launch | Dxcover Limited

7 | HALO Diagnostics, IncellDx Partner to Advance Novel Testing, Improve Standard of Care for Prostate and Bladder Cancers
Product Development Partnership | HALO Diagnostics, IncellDx

Clinical Trials & Study Results

4 | BRAINFUL (BRAIN Tumor Focused Ultrasound-enabled Liquid Biopsy) Trial
Clinical Trial Launch | University Health Network Toronto, Canadian Cancer Society 

5 | Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC (MERIDIAN)
Clinical Trial Launch | University Health Network Toronto, AstraZeneca, Eli Lilly

6 | Minimal residual disease (MRD) detection by ctDNA in relation to radiographic disease progression in patients with stage I-III non–small cell lung cancer (NSCLC) treated with definitive radiation therapy
Study Results | Memorial Sloan Kettering Cancer Institute

7 | Creatv Bio’s LifeTracDx® Liquid Biopsy Predicts Response to New Line of Therapy for Metastatic Breast Cancer within 30 Days
Study Results | Creatv Bio, BriaCell

8 | Angle PLC Announces Potential Role of Invasive Cellular Protrusions
Study Results | Angle PLC, King’s College London

Alex Amram
Senior Analyst
Hannah Glazier
Senior Analyst
Amal Thommil
Senior Analyst
Jackie Wang
Summer Analyst
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