New Study to Evaluate Clinical Effectiveness of CRISPR SARS-CoV-2 Testing

The FDA has granted emergency use authorization (EUA) for several different kinds of assays to detect the SARS-CoV-2 virus, including reverse transcription-polymerase chain reaction (PCR), blood-based serology antibody assays and rapid antigen tests. But while most of us are aware of those tests, there’s also another form of EUA testing that has gotten little attention: tests based on Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology. So far, only one CRISPR product has received EUA for coronavirus detection. But now the company that makes that kit has determined to expand its use and has secured the collaboration of an academic heavyweight to make that happen. The Sherlock-Hitchcock Alliance What may sound like the cast of a murder mystery, the Sherlock-Hitchcock alliance is actually a pairing of Cambridge, Mass-based Sherlock Biosciences with its New England neighbor, the Dartmouth-Hitchcock Health (D-HH) academic health system in New Hampshire. On Aug. 12, the parties announced plans to launch a clinical study of the Sherlock (short for Specific High-sensitivity Enzymatic Reporter unlocking) CRISPR SARS-CoV-2 kit which received EUA on May 7. The kit uses a CRISPR nuclease to detect the genetic signature for SARS-CoV-2 in a swab sample. When the signature is found, the CRISPR enzyme is activated and cuts reporter RNAs provided as part of the kit to release a detectable signal, yielding results in about an hour. Does it work? Is it scalable? The plan calls for DH-H to find out by launching a clinical study to test samples from patients at its member hospitals. “We are excited to partner with Sherlock to understand how the company's novel CRISPR-based test may help circumvent some of the challenges with RT-PCR testing,” noted Gregory Tsongalis, director of D-HH’s Laboratory for Clinical Genomics and Advanced Testing. Testing has begun at D-HH’s member hospitals, Dartmouth-Hitchcock Medical Center, Alice Peck Day Memorial Hospital, Cheshire Medical Center, New London Hospital and Mt. Ascutney Hospital and Health Center. Results are expected in the coming weeks, according to Tsongalis.

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Here’s a summary of other key strategic diagnostic deals announced in August 2020:

STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS
Partner 1	Partner(s) 2+	Deal Summary
Foundation Medicine	OneOncology	Objective: Use real-world clinical and genomics data to improve access to genomic profiling and personalized medicine in community oncology practices Dynamic: Use clinico-genomic datasets to analyze patient data from OneOncology, a network of five independent, community oncology practices representing over 400 providers in US
Thermo Fisher Scientific	Hengrui Therapeutics	Objective: Develop companion diagnostic for identifying lung cancer patients with HER2 mutations eligible for Jiangsu Hengrui Medicine’s treatment pyrotinib Dynamic: Thermo Fisher to retain global commercialization rights to companion diagnostic as part of its Oncomine Precision Assay, which runs on Ion Torrent Genexus System
Thermo Fisher Scientific	Labs from Emory University, Stanford University, University of Cincinnati, and University Health Network in Toronto	Objective: Develop COVID-19 antibody assay for transplant donors and recipients Dynamic: So-called LabScreen COVID Plus assay to be provided under Thermo Fisher’s One Lambda brand and use Luminex xMAP technology to detect multiple antibodies and fragments
RenalytixAI	AstraZeneca + Mount Sinai Health System	Objective: Pursue precision medicine strategies for cardiovascular, rental and metabolic diseases Dynamic: Use RenalytixAI’s KidneyIntelX platform to improve outcomes for patients with chronic kidney disease (CKD)
Amoy Diagnostics	Merck KGaA	Objective: Develop a PCR-based companion diagnostic for Merck’s cancer drug Tepmetko (tepotinib) Dynamic: AmoyDx to develop and seek Japanese approval for its Pan Lung Cancer PCR Panel, which detects 167 hotspot variants in multiple oncogenes, for use as METex14-skipping companion diagnostic for Tepmetko
Genedrive	Beckman Coulter Life Sciences (owned by Danaher)	Objective: Automate the entire laboratory PCR testing process for detecting SARS-CoV-2 Dynamic: Validate Genedrive 96 Sars-CoV-2 kit on Biomek i7 automated workstation using saliva samples extracted with Beckman Coulter’s RNAdvance viral extraction chemistry
IsoPlexis	Department of Medicine at Columbia University	Objective: Study immune response in COVID-19 patients for therapeutics development Dynamic: Use IsoPlexis’ single-cell proteomics platform to identify drivers of durable and protective immune responses to the virus
GeneCentric Therapeutics	Janssen Research & Development	Objective: Discover RNA-based drug response biomarkers for non-muscle invasive bladder cancer (NMIBC) Dynamic: Use GeneCentric’s RNA-based molecular profiling platform to identify potential signatures of disease progression and drug response to standard-of-care therapy
GeneCentric Therapeutics	Erasmus University Medical Center	Objective: Discover RNA-based drug response biomarkers and new therapies for NMIBC Dynamic: GeneCentric to use its Bladder Cancer Subtype Profiler tool to characterize tumor, patient’s immune biology and tumor microenviroment Erasmus to perform retrospective longitudinal genomic analysis on bladder cancer tumor samples from patients who had surgery and received adjuvant treatment
HTG Molecular Diagnostics	Qiagen Manchester (Qiagen subsidiary)	Objective: Provide pharmaceutical companies global development, distribution and commercialization capabilities for companion diagnostic assays based on HTG’s EdgeSeq platform Dynamic: 10-year commercialization and distribution agreement allowing HTG to work directly with biopharma customers to create CDx assays integrating an Illumina or Thermo Fisher Scientific NGS instrument
Biocept	Aegea Biotechnologies	Objective: Develop superior PCR-based COVID-19 assay Dynamic: Sides to leverage their co-owned Switch-Blocker technology Biocept gets first option to negotiate a license agreement to commercialize the assay
Genuity Science (formerly known as WuXi NextCode)	Nashville Biosciences (subsidiary of Vanderbilt University)	Objective: Apply analytics technology to a major clinicogenomic biobank for biomarker and drug discovery, as well as validation and drug development Dynamic: Genuity to sequence, analyze and harmonize samples and deidentified clinical records in BioVU, Vanderbilt’s bank of longitudinal medical records and DNA samples, through its lab in Ireland
Todos Medical	Pathnova	Objective: Advance and commercialize Todos’ breast cancer and SARS-CoV-2 diagnostic kits Dynamic: Pathnova to commercialize tests in Singapore Todos to help Pathnova commercialize its own nasopharyngeal cancer tests in US and Singapore
Pacific Biosciences	Asuragen	Objective: Develop assays based on PacBio’s single-molecule, NGS technology Dynamic: Asuragen researchers to use firm’s AmplideX PCR technology to develop assays for PacBio’s Sequel Systems
Akoya Biosciences	Hellen Diller Family Comprehensive Cancer Center, at University of California, San Francisco	Objective: Develop predictive and prognostic cancer biomarkers for translational research studies Dynamic: Use Akoya’s Phenoptics multiplex immunofluorescence platform to develop biomarkers to help select the most effective neoadjuvant and adjuvant immunotherapies for early-stage breast cancer patients
Veracyte	MaviDx	Objective: Develop ultra-high throughput genomic testing for SARS-CoV-2 on Veracyte’s nCounter diagnostic platform Dynamic: MaviDx to develop, validate, secure regulatory approvals for, and commercialize tests for SARS-CoV-2 and other infectious diseases, including influenza
Atomo Diagnostics	Access Bio	Objective: Commercialize rapid COVID-19 antibody tests Dynamic: Atomo to supply its rapid diagnostic test devices to Access Bio for use with latter’s rapid test strip to detect COVID-19 antibodies to develop 2 co-branded tests—one for professional use and the other a self-test—for launch in US, Canada and Mexico Access Bio must sell at least 2 million tests by Sept. 30, 2021, to maintain exclusive rights in North America
DISTRIBUTION, SALES & MARKETING AGREEMENTS
Property Owner	Distributor	Deal Summary
IsoPlexis	Medquest	Products: IsoPlexis’ IsoLight System and other products for single-cell proteomics research Territory: Singapore, Malaysia Exclusive
Cellex	Avalon GloboCare	Products: Cellex’s COVID-19 antibody-based rapid test kit Territory: Global
Inspirata	Fujifilm	Products: Inspirata’s Dynamyx digital pathology workflow software Territory: Global Fujifilm gets exclusivity in UK, Italy, Spain, Portugal, Belgium, Netherlands, Luxembourg
Siemens Healthineers	Sysmex America	Products: Distribution and servicing of Siemens’ Clinitek Novus Automated Urine Analyzer Territory: North America Exclusive
Fluidigm	De Novo Software	Products: Fluidigm’s mass cytometer platforms to be sold alongside De Novo’s FCS Express 7 Flow suspension data analysis software Territory: Not specified New purchases of Fluidigm’s Helios cytometer and Hyperion imaging system to include one-year license for FCS Express 7 Flow
Maccura Biotechnology	Diazyme Laboratories	Products: Maccura’s SARS-CoV-2 PCR-based test Territory: US
Hangzhou Laihe Biotech	QuestCap	Products: Hangzhou Laihe Biotech’s lateral flow IgM/IgG antibody test kit Territory: US Exclusive
LICENSES
Licensor	Licensee	Deal Summary
Columbia University	Sorrento Therapeutics	Sorrento licenses Columbia’s rapid point-of-care SARS-CoV-2 test which has received EUA from FDA
SUPPLY, SERVICE & TESTING AGREEMENTS
Supplier/Servicer	Client/User	Deal Summary
GeneDx	Pediatrix Medical Group	GeneDx to provide genomic services to physician services firm Pediatrix’s neonatal intensive care units
BBI Solutions	Avacta	BBI to manufacture saliva-based rapid SARS-CoV-2 antigen test that Avacta is developing with Cytiva