Highlights & Summary

 Liquid Biopsy (LBx) continues to develop with each month, featuring more clinical trial updates and platform launches as well as new LBx approvals worldwide.

Clinical & Regulatory

1. Guardant Health, Inc. - Guardant Health Receives Regulatory Approval for Guardant360®CDx in Japan
   Japan MHLW Approval | Guardant Health
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2. Insightec Receives FDA IDE Approval And "Breakthrough" Designation For NSCLC Brain METS Study And IDE Approval For Liquid Biopsy Study
   FDA IDE | Insightec
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3. Veterinarians Using OncoK9® Liquid Biopsy Test in Complex Clinical Cases Can Consult with Specialists Through the Fidu® Telemedicine Platform
   Service Offering Partnership | PetDx, Fidu
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Company Announcements & Product Launches

1. Burning Rock Adds Validation Data as it Begins MRD and Early Detection Commercialization
   MRD Product Launch, Validation Data | Burning Rock
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2. Gene Solutions Makes Earlier Detection of Cancer A Possibility of the Future
   Product Announcement | Gene Solutions
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3. Invitae Launches Full Access to its Liquid-Based Personalized Cancer Monitoring Platform to Help Detect Disease Earlier
   Global Platform Launch | Invitae

Clinical Trials & Study Results‍  

1. Inivata and Collaborators Publish Clinical Validation Data for RaDaR™ Assay in Non-Small Cell Lung Cancer
   Validation Study Data | Inivata, NeoGenomics
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2. Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs TreatedPrimary Liver Cancer
   Clinical Trial Update (NCT05292443) | Geneplus-Beijing Co.
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3. AssesSment of Early-deteCtion basEd oN liquiD Biopsy in LYmphoid Malignancies (ASCEND-LYM)
   Clinical Trial Launch (NCT05275036) |Burning Rock Dx

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M&A | VC | Private Equity | Legal 

1. Illumina sues Guardant Health, founders over trade secrets
   Lawsuit | Illumina, Guardant Health
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2. Lead Independent Director of Natera Board Invests $5M in Company
   HNI Investment | Natera

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Clinical & Regulatory

1 | Guardant Health, Inc. - Guardant Health Receives Regulatory Approval for Guardant360® CDx in Japan

‍The Japanese Ministry of HealthLabor and Welfare (MHLW) gave Guardant360 CDx regulatory approval for CGP in advanced solid tumors. The companion diagnostic was also approved to identify patients with MSI-High solid tumors or MSI-High CRC in order to assign treatments for Keytruda or Opdivo respectively. Guardant 360 CDx was already granted approval back in December 2021 to identify patients with NSCLC who may benefit from LUMAKRAS.                                                                                 

2 | Insightec Receives FDA IDE Approval And "Breakthrough" Designation For NSCLCBrain METS Study And IDE Approval For Liquid Biopsy Study

Insightec, a company that use slow-intensity focused ultrasound (LIFU) to treat and diagnose a range of diseases, received an FDA investigational device exemption (IDE) for the application of its Exablate Neuro System in liquid biopsy for the recurrence monitoring of patients with primary brain cancer. The Exablate Neuro System’s ultrasound transiently increases the permeability of the blood brain barrier, enabling the passage of biomarkers to allow noninvasive liquid biopsy of brain tumors. The same system also received an FDA IDE for applications in primary non-small cell lung cancer (NSCLC) that has metastasized in the brain in conjunction with standard-of-care Keytruda in addition to an FDA Breakthrough Device designation(BDD) for NSCLC treatment.

3 | Veterinarians Using OncoK9® Liquid Biopsy Test in Complex Clinical Cases Can Consult with Specialists Through the Fidu® Telemedicine Platform                                  

PetDx is collaborating with Fidu to offer Fidu’s veterinary tele-consultation service for general practice veterinarians using the OncoK9 multi-cancer early detection liquid biopsy test for dogs. The collaboration provides direct access to internal medicine and oncology consultation, which further adds to customer support services already offered by PetDx. 

Additional Sources

4 | Eurofins Viracor and Cornell University Sign Exclusive Licensing Agreement to ExpandAccess to Ground-Breaking Technologies for Assessing Organ and Tissue Damage inTransplant and COVID-19 Patients

5 | Quanterix Announces New Agreements With Lilly To Advance Alzheimer’s Disease Diagnosis And Treatment  

Company Announcements & Product Launches 

1 | Burning Rock Adds Validation Data as it Begins MRD and Early Detection Commercialization

Burning Rock Biotech is launching its first MRD detection assay, BrPROPHET, with plans to release a six-cancer early detection test shortly thereafter. The company has a pipeline of partner hospitals for implementing the six-cancer screening assays, but COVID-19restrictions are a hindrance to execution. The six-cancer assay will be initially launched as a central lab test, but commercialization is still a possibility. The PREVENT study, consisting of 10,000 patients, will be used to validate the tests. The PROMISE study, which aims to validate Burning Rock's nine-cancer detection product, has just finished its first readout; PROMISE results will be presented with ESMO later this year.  

2 | Gene Solutions Makes Earlier Detection of Cancer A Possibility of the Future

Gene Solutions - Vietnam announced a point-of-care (POC) LBx assay for early cancer screening named SPOT-MAS (Screening for the Presence of Tumor by Methylation And Size).SPOT-MAS aims to be an affordable and easily deployable LBx solution for developing countries. Gene Solutions claims to currently hold 80% and 50% of market share in genetic testing for prenatal screening and oncology, respectively, in Vietnam.

3 | Invitae Launches Full Access to its Liquid-Based Personalized Cancer Monitoring Platform to Help Detect Disease Earlier          

‍Invitae announced full access to its Personalized Cancer Monitoring (PCM) platform to help detect MRDin patients with solid tumors. Invitae PCM is a pan-cancer tumor-informed liquid biopsy assay that uses NGS to analyze ctDNA in plasma, and validation studies have demonstrated greater than 99.9% sensitivity in detecting ctDNA at a 0.008%variant allele frequency. PCM uses tumor-normal whole exome sequencing results and Invitae’s proprietary algorithm to identify 18-50 tumor specific variants to include for the patient’s custom-designed ctDNA panel.  

Additional Sources

4 | Angle PLC Announces Update on Laboratory Accreditation

Clinical Trials & Study Results

1 | Inivata and Collaborators Publish Clinical Validation Data for RaDaR™ Assay in Non-Small Cell Lung Cancer

Inivata's LUngcancer CIrculating tumor DNA (LUCID) study analyzes Inivata's RaDaR LBx test for patients with early-stage NSCLC. In recent published results from the study, RaDaR assays were used to analyze the blood from 88 patients in order to evaluate how ctDNA detected by the assays may relate to recurrence of cancer.The data showed that clinical recurrence of the primary tumor was detected ~212days after ctDNA detection. An additional highlight of the study showed how highly sensitive assays are needed for MRD detection for lung cancer patients, as for 30% of patients with detectable ctDNA, the  VAF was less than 100 parts per million of ctDNA.

2 | Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated Primary Liver Cancer

Geneplus-Beijing Co. (sponsor) and Eastern Hepatobiliary Surgery Hospital (collaborator) initiated a 300 person observational trial on December 20, 2021 for the analysis of ctDNA and peripheral blood mononuclear cell (PBMC) collected before and after the first cycle of immune checkpoint inhibitors (ICI) with an estimated completion date of April 2024. The study includes patients with Primary Liver Cancer, Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, and Combined Hepatocellular-cholangiocarcinoma and analyzes their blood samples for dynamic changes of bTMB (tumor mutational burden), ctDNA, the composition of immune cells, and the combined tumor markers AFP, DCP, and CA19-9.

3 | AssesSment of Early-detection basEd oNliquiD Biopsy in LYmphoid Malignancies (ASCEND-LYM)

ASCEND-LYM is an observational study seeking to build an early detection model for lymphoma based on cfDNA methylation and other unspecified biomarkers. Burning Rock Dx is a collaboration this study, which is expected to enroll around 490 participants and begin inMay 2022.

Additional Sources  

4 | StrataOncology Sentinel Trial for Personalized Cancer Recurrence Monitoring Enrolls First Patient

5 | First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab andR-CHOP

6 | Sema4 Announces Nationwide Expansion of Disparity Study to Deliver Precision Oncology Care to Underserved Communities  

M&A |  VC | Private Equity | Legal

1 | Illumina sues Guardant Health, founders over trade secrets                                                                                                    

Illumina and Guardant Health are currently engaged in a patent infringement court case: Illumina Inc. Guardant Health Inc, U.S. District Court for the District of Delaware, No.1:22-cv-00334. Illumina is requesting ownership of several Guardant patents, transfer of trade secrets, and a sum for damages. Guardant representatives say the company will “vigorously defend” itself during the case. Case updates maybe expected through April.

2 | Lead Independent Director of Natera Board Invests $5M in Company

Roelof Botha, lead independent director of Natera's board of directors and partner at Sequoia Capital, made a $5 million share purchase in Natera. Natera executives and directors also unanimously agreed earlier this week to take company stock instead of salaries and retainers for the remainder of 2022.