Guardant Health Leads Wave of New Cancer Diagnostics Collaborations

by Glenn S. Demby | Jan 4, 2023 | Deals-lir, Essential, Laboratory Industry Report

Deals involving the development and commercialization of new cancer diagnostics and treatments were the most common in December.

Doctor Giving IV Drip Treatment to Cancer Patient. iStock photo

Development and commercialization of new cancer diagnostics and treatments was a prominent theme in strategic dealmaking during the month of December, with the key deals involving a mixture of players and business patterns.

Commercial Lab Company Collaborations with Nonprofits

In several cases, commercial diagnostics companies sought out academic and nonprofit organizations to collaborate on research projects to advance the development of products in their pipeline. For example, cancer genomics company Personalis partnered with the University of California, San Francisco, on research to test the effectiveness of the firm’s NeXT Personal liquid biopsy assay, which is currently available for research use only, in detecting circulating tumor DNA signals indicating treatment response in late-stage colorectal cancer (CRC) patients in combination with treatment with Merck’s Keytruda (pembrolizumab) and Genentech's Avastin (bevacizumab) drugs.¹

In another key deal, Israeli precision medicine startup NewStem enlisted Memorial Sloan Kettering Cancer Center’s MSK Innovation Hub to validate its flagship product, the NewStem Software Diagnostic Device (NSDD) bioinformatics-based cancer diagnostics software, by testing it on patients with triple-negative breast cancer and non-small cell lung cancer.²

Guardant Health Seeks to Bounce Back

Guardant Health was one of the most active dealmakers. What had already been a bad year for the precision oncology firm got much tougher on Dec. 15 when the firm released the results of a prospective ECLIPSE study finding that its Guardant Shield blood-based CRC screening test exhibited a less than overwhelming 83 percent sensitivity and 90 percent specificity in identifying patients who were later diagnosed with CRC.³ Investors responded by driving the company’s stock price down over 30 percent the very next day and, coupled with earlier sell offs, 70 percent for the year.⁴

But December wasn’t a total loss. On Dec. 21, Guardant announced that it was collaborating with nonprofit Susan G. Komen to study the use of the firm’s Guardant Reveal blood-based minimal residual disease (MRD) liquid biopsy test for detecting circulating tumor DNA in early-stage breast cancer patients after surgery to identify those at risk of recurrence who may benefit from adjuvant therapy. “Leveraging [Komen’s] knowledge and resources will help us accelerate the understanding of the clinical value of MRD monitoring and how to personalize care to the specific needs of each patient with early-stage breast cancer to help improve outcomes,” noted Guardant chairman and CEO Helmy Eltoukhy in a statement.⁵

Guardant also got a boost from the pharma industry. On Dec. 8, the week before the release of the ECLIPSE report, Guardant announced that it had signed an agreement with AstraZeneca to develop its Guardant360 CDx liquid biopsy assay as a companion diagnostic for a new breast cancer drug that the pharma giant is developing. The deal calls for the companies to collaborate to develop and commercialize the test for use in identifying patients with ESR1-mutated metastatic breast cancer who would be eligible to enroll in a Phase III study of camizestrant, AstraZeneca's next-generation oral selective estrogen receptor degrader.⁶

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Here’s a summary of key strategic diagnostic deals announced in late November 2022 and December 2022:

Strategic Alliances, Partnerships, & Collaborations

Partner 1	Partner(s) 2+	Deal Summary
Guardant Health	Susan G. Komen	· Objective: Generate clinical data on use of Guardant Reveal blood-based minimal residual disease liquid biopsy test in breast cancer · Dynamic: Collaborate on the design of studies evaluating Guardant Reveal in patients with early-stage breast cancer, and get input from patient advocates to guide trial design
Mission Bio	Abiosciences	· Objective: Create bioinformatics tools for researchers studying hematologic cancers in China · Dynamic: Abiosciences to apply its AI, big data, and single-cell genomics experience to create an analytical algorithm that provides insights into disease progression and development of resistance · Mission Bio to use its Tapestri single-cell multiomics platform to analyze DNA and proteins from patient samples
QuidelOrtho	Runda Medical Technology	· Objective: Develop and manufacture assays for QuidelOrtho's Vitros immunodiagnostic platform in China · Dynamic: Form joint venture between Quidel’s China-based Ortho Clinical Diagnostics Trading subsidiary and Runda Medical’s Shanghai Medconn Biotechnology subsidiary · QuidelOrtho platforms involved include Vitros 3600 and 5600 instruments and Vitros Automation System
NewStem	Memorial Sloan Kettering Cancer Center's MSK Innovation Hub	· Objective: Validate NewStem’s bioinformatics-based cancer diagnostics Software Diagnostic Device (NSDD) product · Dynamic: Focus on patients with triple-negative breast cancer and non-small cell lung cancer who have been treated with paclitaxel and/or carboplatin
MicroGen Diagnostics	Evvy	· Objective: Offer metagenomic next-generation sequencing-based Vaginal Health Test identifying microbes isolated from vaginal and urinary tract · Dynamic: MicroGenDx to perform testing on patient home-collected samples using the test it developed and validated at its CLIA- and CAP-certified lab, with test results and supplementary personalized information delivered via Evvy’s platform
4D Lifetec	Molecular Diagnostics Group	· Objective: Produce and automate 4D Lifetec’s cancer assays and develop tests for high-throughput screening · Dynamic: Agreement covers 4D Lifetec’s 4D Lifetest early cancer assays, including the 4D Lifetest Lung Dx for detection of early-stage lung cancer and CE IVD-marked 4D Lifetest assays for breast, prostate, and colon cancers · Explore jointly developing diagnostic tests combining 4D Lifetest with advanced molecular genetic precision testing for cancer and patient stratification
Guardant Health	AstraZeneca	· Objective: Develop Guardant360 CDx blood-based liquid biopsy assay as companion diagnostic for breast cancer drug being developed by AstraZeneca · Dynamic: Develop and commercialize the test as way to identify patients with ESR1-mutated metastatic breast cancer eligible to enroll in a Phase III trial of AstraZeneca’s camizestrant, a next-generation oral selective estrogen receptor degrader
Lucira Health	Loch Lomond Villa	· Objective: Assess effectiveness of Lucira’s molecular testing platform in managing and minimizing COVID-19 and influenza A/B outbreaks in long-term care settings · Dynamic: Jointly conduct clinical study testing Loch Lomond’s residents, medical and support staff, and visitors for COVID-19 and influenza A/B using Lucira’s COVID-19 & Flu test
WellSpan Health	Helix	· Objective: Develop a population genomics program to improve healthcare outcomes · Dynamic: Program participants from WellSpan, a Pennsylvania regional health system, to contribute DNA samples to be analyzed on Helix’s Exome+ platform, with the results integrated into patients’ electronic medical records
GenScript	Allozymes	· Objective: Deliver enzyme discovery, enzyme development, and protein identification services · Dynamic: GenScript to provide mutant synthetic DNA libraries and protein expression and Allozymes to offer high-throughput screening services for pharmaceutical, cosmetic, and food and beverage industries
Caris Life Sciences	Hummingbird Bioscience	· Objective: Advance clinical development of Hummingbird Bioscience's anti-HER3 therapy, HMBD-001 · Dynamic: Use Caris' genomic and transcriptomic testing and real-world clinico-genomic database to support a precision oncology clinical trial design for the new Hummingbird drug
Pacific Biosciences	Boston Children's Hospital	· Objective: Apply PacBio’s HiFi sequencing technology in pilot project for Children's Rare Disease Cohorts Initiative (CRDC). · Dynamic: Using HiFi whole-genome sequencing (WGS), examine samples from multiple rare disease cohorts that have remained unsolved via short-read whole-exome sequencing · Study to also explore epigenetic variation by measuring DNA methylation
Bio-Techne	Oxford Nanopore Technologies	· Objective: Develop integrated sequencing workflow for carrier screening · Dynamic: Combine long-range PCR technology from Bio-Techne's Asuragen brand with Oxford Nanopore's sequencing capabilities to develop an integrated wet- and dry-lab kit for genotyping 11 genes essential for carrier screening
Envisagenics	Bristol Myers Squibb (BMS)	· Objective: Identify alternative splicing-derived therapeutic targets to expand BMS's oncology pipeline · Dynamic: Leverage Envisagenics' cloud-based SpliceCore artificial intelligence platform to identify disease-specific splicing-derived targets using RNA-seq data from thousands of patients · Envisagenics to receive an upfront payment and milestone payments based on development, regulatory, and commercial achievements
Personalis	University of California, San Francisco	· Objective: Study Personalis’ NeXT Personal liquid biopsy assay in colorectal cancer patients · Dynamic: Use Personalis’ personalized residual disease and monitoring assay to discover circulating tumor DNA signals associated with treatment response and adverse events in a cohort of late-stage CRC patients receiving capecitabine in combination with Merck's Keytruda (pembrolizumab) and Genentech's Avastin (bevacizumab)
Allelica	University of Alabama at Birmingham (UAB) Cardiogenomics Clinic	· Objective: Study the real-world value of polygenic risk scores (PRS) in preventing coronary artery disease (CAD) · Dynamic: UAB to offer Allelica's multi-ancestry PRS testing for CAD (CAD-PRS) to healthy individuals with participating providers to use results to discuss prevention strategies with patients · UAB to survey patients and providers via digital questionnaire one month after result delivery to assess their reactions and perceived usefulness of PRS results · After one year, UAB to evaluate patients' biophysical and lifestyle factors to determine impact, if any, of integrating PRS analysis and reporting in the clinical pathway on an individual's personal risk mitigation actions
OncoDNA	Eli Lilly Italia	· Objective: Provide biomarker testing for thyroid cancer in Italy · Dynamic: Offer next-generation sequencing-based molecular testing on thyroid cancer biopsies to help clinicians identify gene alterations in tumors and link patients with targeted therapies
Halo Diagnostics	Ikonopedia	· Objective: Provide genetic testing for breast cancer to improve early detection · Dynamic: Integrate Ikonopedia's mammography software and radiology reporting with Halo's genetic laboratory and precision diagnostic software services

Distribution, Sales, & Marketing Agreements

Product Owner	Distributor	Deal Summary
Lucira Health	KSL Pulse Scientific	· Products: Lucira Health’s COVID-19 & Flu over-the-counter test · Territory: Canada
Nanomix	Gepa	· Products: Nanomix's handheld eLab electrochemical analyzer and assays · Territory: Italy
Sense Biodetection	R-Biopharm Nederland	· Products: Sense Biodetection’s Veros point-of-care COVID-19 test · Territory: Netherlands, Belgium, Luxembourg · Non-exclusive
Innova Medical Group	iXensor	· Products: Innova’s Phronesia Smart Ovulation Test, which uses iXensor’s technology · Territory: Europe

Licenses

Licensor	Licensee	Deal Summary
Wyss Institute at Harvard University	EnPlusOne Biosciences	EnPlusOne Bio gets exclusive worldwide license to commercialize Wyss’ enzymatic RNA oligonucleotide synthesis technology platform
ERS Genomics	Crown Bioscience	Crown Bioscience gets nonexclusive, worldwide license to use ERS Genomics' CRISPR-Cas9 intellectual property to expand its gene-editing capabilities

Government Contracts

Contractor	Govt. Agency	Contract Summary
QuidelOrtho	U.S. Department of Defense	One of a group of companies to win $803 million contract to produce over-the-counter rapid antigen COVID-19 test kits
OraSure Technologies	U.S. Department of Defense	One of a group of companies to win $803 million contract to produce over-the-counter rapid antigen COVID-19 test kits