Becton Dickinson, Cepheid Unveil Monkeypox PCR Test Collaborations

Although epidemiologists have offered reassurances that monkeypox is of far less concern than COVID-19 was when it first emerged over two years ago, the growing outbreak of cases has spurred an immediate, if not urgent need for new lab tests. As they did in the early days of COVID-19, test makers have responded to the demand for monkeypox tests in record time with Roche, Novacyt, and Eurofins’ Gold Standard Diagnostics launching new assays for the disease. And now some of the lab industry’s biggest players are teaming up to develop new monkeypox diagnostics of their own.

The Cepheid-BioGX Collaboration

On June 24, Cepheid and BioGX announced a collaboration to create a PCR assay for monkeypox on the former’s GeneXpert, a system with an installed base of over 40,000 instruments in 180 countries. The assay will be provided as part of Cepheid’s FleXible Cartridge for GeneXpert, the companies stated. “Our FleXible Cartridge program gives Cepheid the ability to work with external partners to develop accurate tests quickly when the need arises,” noted Cepheid executive vice president David Persing in a statement.

The external partner in this situation of need is BioGX, an Alabama-based supplier of lyophilized real-time PCR reagents for molecular diagnostics and subsidiary of the Dutch firm BioGX B.V. The firms have a track record of successful collaboration, having previously developed and manufactured a multiplex monkeypox and orthopoxvirus test for a GeneXpert-based study published in 2017 for the US Centers for Disease Control and Prevention (CDC).

The Becton Dickinson-CerTest Collaboration

About two weeks earlier, Becton Dickinson (BD) and Spanish molecular test maker CerTest Biotec announced their own collaboration to develop a PCR-based test for monkeypox to run on the BD Max System. The plan calls for using BD Max open system reagents to validate CerTest’s CE-IVD-marked Viasure Monkeypox molecular test. The firms will offer the resulting Monkeypox PCR Detection Kit for the BD Max in a lyophilized format that comes in a tube and snaps into the BD Max ExK TNA extraction kit.

Again, the firms have a history with each other. CerTest has previously created other assays for the BD Max, including assays for SARS-CoV-2 detection and variant monitoring, as well as a COVID-19/flu/RSV combination test.

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Here’s a summary of some of other key strategic diagnostic deals announced in June 2022:

Strategic Alliances, Partnerships, & Collaborations

Partner 1	Partner(s) 2+	Deal Summary
Roche Diagnostics	Nordic Bioscience	• Objective: Develop biomarkers for Roche's Cobas system • Dynamic: Nordic to transfer its blood-based biomarkers for chronic diseases involving tissue fibrosis and inflammation to Roche for implementation on Cobas platform
Foundation Medicine (Roche subsidiary)	The Lung Cancer Research Foundation and Lung Cancer Mutation Consortium	• Objective: Perform trial to determine how blood-based comprehensive genomic profiling tests (CGP) complement tissue-based CGP testing to inform targeted treatment in resectable non-small cell lung cancer (NSCLC) • Dynamic: Trial to use FoundationOne CDx assay and blood-based FoundationOne Liquid CDx test to screen for 11 actionable driver mutations in 1,000 patients with high-risk, resectable NSCLC who are candidates for neoadjuvant therapy
Foundation Medicine	Arvinas	• Objective: Create companion diagnostic for investigational prostate cancer drug • Dynamic: Develop FoundationOne Liquid CDx as companion diagnostic for use with Arvinas' bavdegalutamide (ARV-110), an investigational protein degrader targeting the androgen receptor
PerkinElmer	Novartis	• Objective: Expand newborn screening for sickle cell disease in sub-Saharan Africa • Dynamic: PerkinElmer to provide training, consultations, support, and help establish new lab facilities to build capacity for sickle cell disease screening in countries participating in Novartis' program
Illumina	Precision Health Research Singapore (PRECISE)	• Objective: Sequence and analyze genomes of 100,000 Singaporeans as part of a population study • Dynamic: 3-year partnership to leverage Illumina’s capabilities in large-scale genomic sequencing to build enterprise-grade data exchange platforms for secure data handling and sharing and develop artificial intelligence for genomics analysis
Grail (subsidiary of Illumina)	AstraZeneca	• Objective: Develop and commercialize companion diagnostics for AstraZeneca’s therapies • Dynamic: Multiple studies intended with initial focus on companion diagnostics to identify cancer patients with high-risk, early-stage disease
Paige	Janssen Research & Development	• Objective: Evaluate potential of Janssen’s hematoxylin and eosin (H&E) and AI-based biomarker test • Dynamic: Create first-of-its-kind screening tool to predict presence of certain actionable alterations in the fibroblast growth factor receptor (FGFR) genes in patients with advanced bladder cancer
Tempus	Intermountain Healthcare	• Objective: Generate molecular data for personalized cancer research • Dynamic: Intermountain will use Tempus' xT broad-panel genomic sequencing assay to generate whole transcriptomic data on existing samples to advance its research
Tempus	Eli Lilly	• Objective: Improve advanced NSCLC patient access to genomic testing • Dynamic: Tempus to offer its xT broad-panel genomic sequencing assay, xF liquid biopsy, and immunohistochemistry tests to physicians treating NSCLC patients free of charge, with Lilly to cover the costs of the tests
Bionano Genomics	Hamilton	• Objective: Develop automated system for extraction of ultra-high molecular weight (UHMW) DNA for use in optical genome mapping (OGM) • Dynamic: Long String Vantage workstation to support extraction of UHMW DNA at increased scale
Becton Dickinson	CerTest Biotec	• Objective: Develop monkeypox RT-PCR-based test to run on BD Max System • Dynamic: Use BD Max open system reagent suite to validate the CerTest Viasure Monkeypox CE-IVD-marked molecular test on the BD Max
Sophia Genetics	Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) + Diagnóstica Longwood	• Objective: Roll out new software tool for chronic lymphocytic leukemia (CLL) analysis • Dynamic: Application, run on top of Sophia's core Data Driven Medicine (DDM) platform, to improve integration of genomic results from CLL research into clinical practice, enabling earlier detection of the disease
Rebus Biosystems	Rosalind	• Objective: Codevelop software to analyze single-cell spatial omics data • Dynamic: Software to combine multiomic analytics capabilities of the Rebus Esper system and interactive interface of Rosalind's technology platform
Roswell Biotechnologies	UCB	• Objective: Evaluate usefulness of Roswell's Molecular Electronics (ME) platform and chip for drug discovery in neurological, immunological, and rare diseases • Dynamic: Roswell to use the chip to detect binding partners to a variety of molecules including DNA and RNA oligos, aptamers, antibodies, and other proteins
Quotient Limited	Theradiag	• Objective: Develop autoimmune diagnostics on Quotient's MosaiQ platform • Dynamic: Quotient to develop a microarray-based test for connective tissue diseases with Theradiag support • Theradiag to provide Quotient autoimmune reagents and multi-constituent quality controls
Singular Genomics	TwinStrand Biosciences	• Objective: Develop tool for detecting rare variants with greater sensitivity and specificity than non-duplex NGS-based liquid biopsies at lower cost • Dynamic: Combine TwinStrand's duplex sequencing method with Singular's HD-Seq technology on the G4 sequencing platform for applications such as minimal residual disease (MRD) detection
BioMark Diagnostics	Icahn School of Medicine at Mount Sinai	• Objective: Develop early-stage lung cancer diagnostics • Dynamic: BioMark, which is developing a multiomic liquid biopsy assay for early detection and screening of lung cancer, to take part in clinical studies with Icahn Mount Sinai to study at-risk populations with its plasma biomarkers and machine-learning tools
Genomenon	Agilent Technologies	• Objective: Integrate Genomenon’s Mastermind Genomic Search Engine into Agilent’s Alissa Interpret genomic data analysis and variant interpretation software • Dynamic: Phase 1: Add links from Alissa Interpret to Mastermind, enabling users to filter and review variants in Agilent product and click for related medical evidence provided by Genomenon • Phase 2: Deeper integration via Mastermind's application programming interface, enabling researchers to review literature search results without leaving Alissa Interpret
Thermo Fisher Scientific	TransMIT Center for Mass Spectrometric Developments at Justus Liebig University Giessen	• Objective: Promote mass spectrometry imaging platform • Dynamic: Comarketing agreement combining Thermo Fisher’s Orbitrap mass spec instrumentation with TransMIT's scanning microprobe matrix-assisted laser desorption/ionization (SMALDI) and 3D-surface technology to create system allowing researchers to perform spatial analyses of various analytes
Nucleai	Ultivue	• Objective: Develop AI-supported spatial biology analysis platform for pathology images to speed drug development • Dynamic: Comarketing agreement to integrate Nucleai's AI spatial models with Ultivue's imaging technology
Ultima Genomics	Nvidia	• Objective: Create platform to accelerate genome analysis • Dynamic: Embed Nvidia graphics processing units into Ultima’s UG 100 high-throughput NGS instruments
Biodesix	Memorial Sloan Kettering Cancer Center	• Objective: Develop a minimal residual disease (MRD) test for MSK • Dynamic: Master sponsored research agreement to develop test on Bio-Rad QX600 ddPCR System • Agreement also provides for potential future development of other cancer diagnostic tests
Caris Life Sciences	Sorrento Therapeutics + The Prostate Cancer Clinical Trial Consortium	• Objective: Develop tests that use precision oncology to guide advanced prostate cancer treatment • Dynamic: Caris to use its Molecular Intelligence (MI) multi-platform tumor profiling test to analyze whole exome DNA, whole transcriptome RNA, and proteins from prostate cancer patients in Sorrento-sponsored Phase II Maverick trial to create biomarker tests, helping investigators better understand patients' responses and resistance to therapy
Gencove	Element Biosciences	• Objective: Provide low-pass whole-genome sequencing and analysis on Element's Aviti system • Dynamic: Comarketing agreement pairing Gencove’s low-pass sequencing and analysis software with newly launched Aviti platform to achieve cost-effective whole-genome sequencing
Sema4	Avera Health	• Objective: Advance precision oncology care • Dynamic: 5-year study (called the Avera/Sema4 Oncology and Analytics Protocol (ASAP) study) to enroll up to 3,000 patients annually for tumor sequencing and testing for hereditary cancer and pharmacogenomics
OneCellDx	Genetics Institute of America	• Objective: Commercialize OneCellDx's OncoPredikt HRD Assay • Dynamic: GIA to create a laboratory-developed test based on OneCellDx's AI-enabled algorithm and assay, for identifying genomic signatures associated with homologous recombination deficiency in cancer patients
CorePath Laboratories	Cizzle Biotechnology	• Objective: Develop and offer early-stage lung cancer liquid biopsy test in US • Dynamic: CorePath to commercialize Cizzle’s test for detecting C1Z1B variant in blood samples to help prevent false positive rates in low-dose CT scanning leading to unnecessary invasive testing assay • Cizzle to get 15% royalties on all product and services offerings using CIZ1B test in US

Distribution, Sales, & Marketing Agreements

Licensor	Licensee	Deal Summary
Wyss Institute (Harvard University)	StataDx	Massachusetts startup gets exclusive license for worldwide use of eRapid affinity-based, multiplexed, electrochemical sensing technology for neurological, cardiovascular, and renal diseases
SomaLogic	OncoHost	OncoHost gets right to use SomaLogic's SomaScan platform to develop proteomic tests for its own Prophet diagnostic system to predict response to immunotherapy treatments

Licenses

Licensor	Licensee	Deal Summary
Wyss Institute (Harvard University)	StataDx	Massachusetts startup gets exclusive license for worldwide use of eRapid affinity-based, multiplexed, electrochemical sensing technology for neurological, cardiovascular, and renal diseases
SomaLogic	OncoHost	OncoHost gets right to use SomaLogic's SomaScan platform to develop proteomic tests for its own Prophet diagnostic system to predict response to immunotherapy treatments

Government Contracts

Contractor	Govt. Agency	Contract Summary
OraSure Technologies	HHS	OraSure to supply its InteliSwab COVID-19 Rapid Test to schools under HHS program nationwide school testing program as part of firm’s $205.2 million procurement contract from the US Defense Logistics Agency signed last September