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