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Becton Dickinson Lands $40.3 Million BARDA Contract to Develop 510(k)-Worthy COVID-19 Tests

by Glenn S. Demby | Nov 4, 2021 | Articles, Deals-lir, Essential, Laboratory Industry Report, Must read

Global medical tech company Becton Dickinson (BD) has been a leader in the effort to pioneer new diagnostic tests for COVID-19, having obtained FDA Emergency Use Authorization for COVID-19, flu A, and flu B combination tests that run on both the BD Max and BD Veritor Plus platforms. BD is now seeking to take things to another level by teaming with the Biomedical Advanced Research and Development Authority (BARDA) on a government contract designed to create novel combination COVID-19 assays that will garner full 510(k) clearance. The BD-BARDA Collaboration BARDA, a division of the US Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, and BD have formed public-private partnership to support development of combination diagnostic tests to detect COVID-19 and other targets at core labs, hospitals and the point of care. BARDA will provide $24.7 million in initial funding, with options to extend up to $40.3 million. The 5 Target Tests According to BD, the objective is to develop and gain 510(k) clearance for five different combination tests to create a panel for use at all levels of the healthcare system. The first test, the BD Veritor Plus System Respiratory Panel, will be a rapid […]

The BD-BARDA Collaboration

BARDA, a division of the US Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, and BD have formed public-private partnership to support development of combination diagnostic tests to detect COVID-19 and other targets at core labs, hospitals and the point of care. BARDA will provide $24.7 million in initial funding, with options to extend up to $40.3 million.

The 5 Target Tests

According to BD, the objective is to develop and gain 510(k) clearance for five different combination tests to create a panel for use at all levels of the healthcare system. The first test, the BD Veritor Plus System Respiratory Panel, will be a rapid point-of-care antigen test run on the BD Veritor system capable of detecting and distinguishing SARS-CoV-2, influenza A and influenza B.

The Franklin Lakes, New Jersey-based company will also develop four molecular assays, two for the BD Max and two for the BD Cor system. The BD Max assays are intended for use in hospitals and moderate throughput labs, including the:

BD Max System Respiratory Panel to detect and distinguish between SARS-CoV-2, influenza A and B, and respiratory syncytial; and
BD Max System Respiratory Panel plus Pan-Coronavirus to detect and distinguish between SARS-CoV-1, Middle East Respiratory Syndrome, seasonal coronaviruses and novel or emerging coronaviruses.

The firm will also develop two BD Cor system tests, the BD Cor System Respiratory Panel and BD Cor System Respiratory Panel plus Pan-Coronavirus, that reference labs and high-throughput diagnostics settings can use to detect and distinguish the same targets as the Max system panels.

Here’s a summary of other key strategic diagnostic deals announced in October 2021:

STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS

Partner 1	Partner(s) 2+	Deal Summary
Roche	PathAI	Objective: Develop and distribute AI-based digital pathology applications Dynamic: Jointly create embedded image analysis workflow for pathologists enabling PathAI’s image analysis algorithms to be accessed within Roche’s Navify Digital Pathology cloud software
Roche	Prenosis	Objective: Improve sepsis detection Dynamic: Expand current partnership enabling Prenosis to expand its NOSIS dataset Partners also to seek FDA clearance for Prenosis Sepsis Immunoscore and Roche Elecsys IL-6 assay
Vibrent Health	Virginia Commonwealth University	Objective: Launch new research platform to study genetic and environmental influences underlying individual differences in twins Dynamic: Operating in collaboration with VCU Wright Center, Global Twin Research Platform consolidates data from otherwise disconnected twin registries, providing access to larger combined datasets
Inivata	Princess Margaret Cancer Centre	Objective: Use Inivata’s InVisionFirst-Lung and RaDaR liquid biopsy assays in two clinical lung cancer studies Dynamic: Study 1 to compare how long it takes patients to begin non-small cell lung carcinoma treatment after diagnosis via liquid biopsy vs. conventional molecular testing after imaging and biopsy Study 2 to use Inivata RaDaR assay to identify curative therapy candidates after lung cancer resection via signs of minimal residual disease
Imec	Johns Hopkins University	Objective: Commercialize COVID-19 breathalyzer Dynamic: Licensing agreement enabling Imec spinoff MiDiagnostics to start commercialization process
Caris Life Sciences	Ono Pharmaceutical	Objective: Develop immune-based cancer therapies Dynamic: Use Caris’ molecular profiling technologies for studies of investigational targeted and immune-based cancer therapies
C2i Genomics	NuProbe Global	Objective: Expand C2i’s AI-based cancer platform and NuProbe’s chemistry products and sequencing networks in China and US Dynamic: Develop chemistry and software products expanding traditional whole-genome library preparation to include additional signal enrichment for cancer hotspots, microsatellite instability and fusions
Personalis	Mayo Clinic	Objective: Offer clinical-grade comprehensive cancer genomic sequencing to patients Dynamic: Research collaboration to make results from Personalis’ whole-exome and transcriptome sequencing results available to participating patients and their providers to guide therapeutic decisions
GeneDx	Krystal Biotech	Objective: Provide free genetic testing for epidermolysis bullosa, a rare skin disorder that Krystal is developing a treatment for Dynamic: Offer no-cost testing for all forms of EB, with goal of helping dystrophic EB patients get a diagnosis sooner
Destina Genomics	Mecwins	Objective: Develop RNA biomarker tests for drug-induced toxicity, as well as therapeutic RNAs Dynamic: Cross-licensing agreement enabling companies to share their RNA quantification technology with aim of reducing the risk of error in late-stage clinical trials and speeding development and implementation of scalable molecular tests
Deepcell	University of Zurich’s Levesque Lab	Objective: Conduct study of the tumor microenvironment in melanomas Dynamic: Researchers to use Deepcell’s platform for isolating cells based on morphological features rather than labeling or predefined biomarkers to sort cells for downstream molecular analysis
Laboratory Corporation of America	GeneCentric Therapeutics	Objective: Develop and commercialize RNA-based signatures for diagnosing cancer Dynamic: GeneCentric to develop signatures in collaboration with Labcorp Drug Development, with tests produced by the project deployed to major academic and community cancer centers through Labcorp Diagnostics
Invitae	Outcomes4Me	Objective: Develop mobile apps to improve education and access to genetic testing for breast cancer patients and survivors Dynamic: Allow patients to make a genetic counseling appointment and order testing directly from Outcomes4Me’s platform
Speedx Pty Ltd.	Syngenis	Objective: Develop a new at-home rapid PCR test ensuring that Australia can become self-sufficient in producing PCR tests Dynamic: Speedx Pty Ltd. to invest Syngenis, a Perth-based startup that makes raw materials needed for PCR COVID-19 tests
DNAe	Imperial College London+University of Leicester	Objective: Develop liquid biopsy test to monitor treatment and detect early recurrence of breast cancer Dynamic: Leverage DNAe’s next-generation sequencing technology to create test
Blueprint Genetics	BioMarin	Objective: Provide free genetic testing for people suspected of having inherited skeletal dysplasia Dynamic: Launch free testing program for physicians in Europe and Middle East
Genetron Health	Jiangsu Fosun Pharmaceutical Sales (subsidiary of Shanghai Fosun Pharmaceutical)	Objective: Commercialize Genetron Health’s minimal residual disease assay Seq-MRD in China Dynamic: Exclusive agreement to co-market and co-promote Seq-MRD in hematologic-focused hospitals and clinics across China
Genoox	Aspira Women’s Health	Objective: Develop AI and machine learning-driven technologies to improve molecular diagnosis and creation of treatment plans for conditions affecting women in early disease stages Dynamic: Create new tests backed by data analysis by bringing together Aspira’s biobank and algorithms with Genoox’s bioinformatics platform
Twist Bioscience	Centogene	Objective: Develop and commercialize sequencing assay kits for rare disease genetic testing. Dynamic: Assays to = combine Centogene’s experience in rare disease diagnostics with Twist’s target enrichment capabilities for NGS library preparation
Cue Health	Google Cloud	Objective: Add respiratory viral variant sequencing and tracking to Cue Integrated Care platform Dynamic: Cue to build Google Cloud’s AI, machine learning, analytics, and privacy and security tools into its platform, which includes its Cue Health Monitoring System and rapid molecular COVID-19 test
OncoDNA	Sophia Genetics	Objective: Improve analysis and interpretation of genomic profiles Dynamic: OncoDNA to customize its OncoKDM genomic interpretation platform to work with Sophia’s DDM genomic analytics technology

DISTRIBUTION, SALES & MARKETING AGREEMENTS

Product Owner	Distributor	Deal Summary
Tasso	InnoVero	Products: Tasso’s blood collection devices for anti-doping testing Territory: Worldwide Exclusive
Deep Bio	Healthcare Konnect	Products: Deep Bio’s AI-based DeepDx Prostate software Territory: Switzerland, Morocco, Algeria, Egypt, Tunisia
Parse Biosciences	Decode Science	Products: Parse’s single-cell RNA-seq solutions Territory: Australia and New Zealand Exclusive
Clever Culture Systems	Remel (subsidiary of Thermo Fisher Scientific)	Products: CCS’ APAS Independence automated culture screening and interpretation system Territory: US Five-year exclusive agreement
Mawi DNA Technologies	Fujifilm Wako Pure Chemical	Products: Mawi’s iSWAB biosampling products Territory: Japan Fujifilm to be an authorized Japanese distributor of iSWAB line including iSWAB Microbiome-EL sample collection tubes
Euformatics	Singapore All Eights	Products: All of Euformatics’ products, including Omnomics interpretation and validation software for next-generation sequencing Territory: Malaysia
Euformatics	Biomedic	Products: All of Euformatics’ products, including Omnomics interpretation and validation software for next-generation sequencing Territory: Vietnam

LICENSES

Licensor	Licensee	Deal Summary
Atreca	Bill & Melinda Gates Medical Research Institute (MRI)	Oncology biotech Atreca licenses its preclinical monoclonal antibody for potential treatment of malaria
Inscripta	Hunterian Medicine	Gene editing and gene therapy company Hunterian gets nonexclusive access to Inscripta’s MAD7 CRISPR nuclease enzyme for use in developing human therapeutics
MilliporeSigma	Cellecta	Merck KGaA firm licenses CRISPR-Cas9 technology to functional genomics products and services provider

GOVERNMENT CONTRACTS

Contractor	Govt. Agency	Contract Summary
Quest	Texas Department of State Health Services	Quest to provide COVID-19 testing for K-12 schools in Texas via its labs in the Houston and Dallas-Fort Worth areas
Eurofins Genomics US	US Department of the Air Force and Department of Health and Human Services	$30 million contract to build a new production facility and to expand manufacturing capacity for reagents used in COVID-19 diagnostic tests
OraSure Technologies	US Department of Defense	$109 million contract for manufacturing scale-up for OraSure’s InteliSwab rapid SARS-CoV-2 antigen assays

Becton Dickinson Lands $40.3 Million BARDA Contract to Develop 510(k)-Worthy COVID-19 Tests

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