DX Deals

Abbott Lands $255 Million Rapid COVID-19 Antigen Test Pentagon Contract

In invoking the Defense Production Act (DPA), the Biden Administration has authorized the federal government to mobilize private industry in the war against coronavirus. The administration is also awarding lucrative contracts to companies to furnish COVID-19 tests, particularly rapid assays that can be used for screening purposes at the point of care. On March 19, Abbott Laboratories landed one of those juicy contracts: a $255 million deal from U.S. Department of Defense for SARS-CoV-2 rapid antigen tests.

Terms of the Contract

Awarded by the Defense Logistics Agency (DLA), the contract is an eight-month deal requiring Abbott to supply its BinaxNOW COVID-19 Ag Card rapid antigen tests for use in DLA Troop Support Program activities in Maine and Florida. The funding is coming from the Department of Health and Human Services’ (HHS) Office of Assistant Secretary of Health.

The initial package calls for 50 million BinaxNOW tests at $255 million, but there may be many more to follow. That’s because the deal is structured as a firm-fixed-price, indefinite-delivery/indefinite-quantity contract with no option periods. In other words, the DLA can order more tests before the ordering period ends on Oct. 31, up to a maximum of $766.4 million.

Abbott’s Strategic Position in the Federal Government Contract Market

BinaxNOW is a lateral flow immunoassay that detects the nucleocapsid protein associated with the SARS-CoV-2 virus in 15 minutes. Abbott has done a lot of BinaxNOW business with the federal government since the pandemic began. In August, the test received Emergency Use Authorization (EUA) for use at the point of care. The very next day, HHS awarded Abbott a $760 million contract for the purchase of 150 million BinaxNOW tests (just a bit over $5 per test) to distribute to nursing homes, assisted living facilities, hospice agencies and other congregate care and vulnerable settings. Then, in December, when the FDA reissued the BinaxNOW EUA to allow for virtually guided home use with a prescription, HHS bought another $30 million worth of the test.

But there were also some rough patches in between. The Trump Administration halted shipments of BinaxNOW to eight states in November as part of a squabble between the president and governors over breakdowns in test distribution and who was at fault for causing them.

The new administration’s COVID-19 testing plan provides $10 billion to states for tests enabling schools to safely reopen during the remainder of the academic year—including both PCR and rapid screening tests. BinaxNOW is considered a strong contender for the screening test portion of the school testing program. The new DLA contract is separate from that program.

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

Strategic Alliances, Partnerships & Collaborations

Partner 1 Partner(s) 2+ Deal Summary
Thermo Fisher Scientific Color Health
  • Objective: Provide COVID-19 testing for U.S. schools
  • Dynamic: Thermo Fisher to offer integrated COVID-19 testing to school districts nationwide via a network of testing labs, with support from Color
  • Funded through Biden Administration’s allocation of $10 billion for COVID-19 testing
Thermo Fisher Scientific Protein Metrics
  • Objective: Comarket each firm’s mass spectrometry data platforms for biopharma and proteomics
  • Dynamic: Non-exclusive agreement covers Thermo Scientific Chromeleon CDS software and Protein Metrics’ Byos platform for protein characterization and Byosphere enterprise platform for automation, collaboration and data management
Thermo Fisher Scientific Artificial
  • Objective: Develop software automation platform for Thermo Fisher’s COVID-19 testing platform
  • Dynamic: Artificial to provide access to its aLab Suite software, which integrates with Thermo Scientific Momentum Workflow software and robotics hardware
CellMax Life Sebela Pharmaceuticals
  • Objective: Complete commercial development of CellMax’s FirstSight liquid biopsy assay
  • Dynamic: Sebela to seek FDA 510(k) approval for assay, which uses a microfluidic chip with a non-sticky nanolayer, high-affinity antibodies, and air-foam technology to capture and release cells
 Lucence Waseda University
  • Objective: Develop rapid laser-based liquid biopsy platform to image circulating tumor cell (CTCs) and clusters in a patient’s blood sample
  • Dynamic: Lucence to build a circulating cell atlas for analyzing CTCs and cell clusters with deep learning algorithms
  • Lucence gets exclusive licenses from Waseda to support the platform’s development, with plans to commercialize it via its CLIA-licensed lab in Palo Alto, California
Aptamer Group Mologic
  • Objective: Develop rapid aptamer-based SARS-CoV-2 antigen test
  • Dynamic: Mologic will help Aptamer develop and eventually manufacture AptaDx rapid lateral flow assay to detect SARS-CoV-2 spike protein antigen in anterior nasal swabs
Genialis BioLab
  • Objective: Develop new algorithms and computing methods for choosing therapeutic options for patients based on disease subtype recombination deficiency (HRD)
  • Dynamic: Sponsored research agreement BioLab, the bioinformatics lab at University of Ljubljana in Slovenia
Stella Diagnostics University of Kansas Medical Center
  • Objective: Evaluate clinical use of Stella’s proteomics panel for patients with Barrett’s esophagus
  • Dynamic: A assess Stella’s mass spectrometry-based STLA101 assay by quantifying novel proto-oncogenes in Barrett’s esophagus tissue that have and haven’t progressed to cancer
Illumina Geneseeq Technology
  • Objective: Develop next-generation sequencing (NGS)-based cancer profiling kits for China market
  • Dynamic: Geneseeq to develop kits for Illumina’s NextSeq 550Dx platform based on GeneseeqPrime, a comprehensive genomic profiling panel that assesses tumor mutational burden (TMB) and microsatellite instability
  • Geneseeq to conduct studies with Illumina to provide IVD instruments and components
  • Tests to be made available directly to patients via Geneseeq and at hospital testing centers
NeoGenomics Elevation Oncology
  • Objective: Identify patients with a solid tumor who have an NRG1 fusion and may qualify for Elevation’s Phase II CRESTONE study
  • Dynamic: CRESTONE trial is studying activity of the HER3 monoclonal antibody seribantumab in NRG1 fusion-positive tumor patients
iAssay DDTD (Drugs &n Diagnostics for Tropical Diseases)
  • Objective: Facilitate use of iAssay instrument to read, interpret and transmit test images and speed reporting of test results to physicians
  • Dynamic: Memorandum of Understanding MOU allowing organizations to provide DDTD’s COVID-19 serology tests with automatic, digitized reads using iAssay’s SimpleCloud Amazon Web Services portal to health records
Proscia Ibex Medical Analytics
  • Objective: Create integrated product for artificial intelligence-based prostate cancer diagnosis
  • Dynamic: Combine Proscia’s Concentriq image and data management platform with Ibex’s AI-based Galen Prostate system
Foundation Medicine InformedDNA
  • Objective: Offer expanded access to genetic counseling and confirmatory genetic testing to patients with potential inherited cancer gene mutations
  • Dynamic: Patients receiving Foundation’s comprehensive genomic profiling tests and get results showing potential inherited cancer gene variants to get option to be referred by physicians to InformedDNA’s genetic counseling services and confirmatory genetic testing
  • If confirmatory testing is needed, InformedDNA genetic counselors will help patients determine the appropriate test
Bio-Rad Laboratories Roche
  • Objective: Provide Bio-Rad’s InteliQ quality control products
  • Dynamic: Bio-Rad to offer Roche customers access to InteliQ QC tubes and Unity QC data management solutions
Genetic Technologies Infinity Biologix
  • Objective: Commercialize Genetic Technologies’ COVID-19 risk test in U.S.
  • Dynamic: 3-year deal to collaborate on production, distribution, sales and marketing of test, which will be sold under the “powered by GeneType”
  • Infinity Biologix to make minimum payments to Genetic Technologies of $2.9 million over term of partnership to maintain exclusivity
Tempus Precision Health Informatics (part of Texas Oncology)
  • Objective: Advance precision oncology research and personalized treatment decisions
  • Dynamic: Precision Health Informatics to use Tempus’ AI-powered platform and genomic sequencing capabilities with Tempus to also help Precision Health Informatics mine its database
Twist Bioscience Watchmaker Genomics
  • Objective: Develop high-throughput NGS applications for tumor profiling, inherited disease diagnostics, liquid biopsies and minimal residual disease (MRD) monitoring
  • Dynamic: Products to incorporate Watchmaker’s high-fidelity library amplification master mix into Twist’s enzymatic library preparation kit
  • Other potential application areas include cell-free DNA, circulating tumor DNA, single-cell genomics, low allele somatic variant detection and tumor mutation burden
Myriad Genetics Intermountain Precision Genomics (Intermountain Healthcare)
  • Objective: Offer tumor tissue profiling services
  • Dynamic: Combine Myriad’s hereditary cancer risk tests, including Myriad’s myRisk Hereditary Cancer test, and companion diagnostics into a single profiling service offered through Intermountain
Crown Bioscience Cambridge Quantum Computing
  • Objective: Identify new cancer treatment biomarkers
  • Dynamic: Combine CQC’s quantum machine algorithms and software development capabilities with CrownBio’s preclinical and translational research expertise to identify multi-gene biomarkers for use in cancer drug discovery

Distribution, Sales & Marketing Agreements

Product Owner Distributor Deal Summary
Paige Epredia
  • Products: Paige Platform pathology image viewer and storage system and other diagnostic imaging products
  • Territory: Global with exclusivity in Japan
Namocell OLS OMNI Life Science
  • Products: Namocell’s Single Cell Dispensers
  • Territory: Germany and Austria
SpeeDx Neogen Diagnostik
  • Products: SpeeDx’s ResistancePlus and PlexPCR diagnostic tests
  • Territory: Turkey
Congenica Amplitech
  • Products: Congenica’s clinical decision support platform
  • Territory: France, Belgium, Luxembourg, Switzerland
Microbix Biosystems Seegene Canada
  • Products: Microbix’s COVID-variant Quality Assessment Products (QAPs) to monitor the workflow accuracy of Seegene Allplex assays
  • Territory: Canada
  • Parties also extended the scope and duration of their existing hemostasis testing systems and reagents global distribution agreement
Abingdon Health BioSure UK
  • Products: Abingdon’s AbC-19, a rapid SARS-CoV-2 neutralizing antibody test
  • Territory: UK, Europe
  • Non-exclusive
Agena Bioscience Alliance Global
  • Products: Agena’s MassArray platform and related products
  • Territory: Middle East, Africa, Central Asia
  • Exclusive
Lumos Diagnostics Northern Diagnostics
  • Products: Lumos’ FebriDx point-of-care acute respiratory infection assay
  • Canada

Licenses

Licensor Licensee Deal Summary
Zora Biosciences Quest Diagnostics Quest gets non-exclusive license for Zora’s Espoo ceramide biomarker technology for use to develop test identifying patients at risk of cardiovascular conditions and death
ERS Genomics Setsuro Tech Non-exclusive license to ERS’ CRISPR-Cas9 patent portfolio in Japan to develop and supply cell and animal models
ERS Genomics Otsuka Pharmaceutical Non-exclusive license to ERS’ CRISPR-Cas9 patent portfolio in Japan

Supply, Service, Testing & Manufacturing Agreements

Supplier/Servicer Client/User Deal Summary
Todos Medical Majl Diagnostics Todos to provide all of Majl’s COVID-19 PCR testing reagents and supplies for
Abbott Rapid DX U.S. Department of Defense $255 million contract for Abbott to provide 50 million SARS-CoV-2 rapid point-of-care antigen tests
Roche Government of Germany Roche to provide up to 10.5 million SARS-CoV-2 Rapid Antigen Nasal Tests to German states for self-testing
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