DX Deals

Amazon Already Making a Mark on Direct-to-Consumer COVID-19 Test Market

Will Amazon transform diagnostic lab testing the way it did the retail industry?

Probably not. But the tech giant with the proven capacity to reach into the home and change the shopping patterns of consumers has determined to make an impact on health care. And after establishing its Amazon Care telehealth service and launching its own Halo wellness-tracking smartwatch, Amazon has made significant inroads into the COVID-19 diagnostics market.

The Amazon COVID-19 Kit

During the pandemic, Amazon developed a proprietary COVID-19 RT PCR test to screen its own employees. In March, the FDA granted emergency use authorization (EUA) for the Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 which detects the ORF1ab gene of the virus in anterior nasal swab specimens that can be self-collected using either the Amazon COVID-19 Collection Kit under the supervision of a healthcare provider or the Amazon COVID-19 Test Collection Kit unsupervised at home. On June 8, the FDA granted Amazon.com subsidiary STS Lab Holdco an EUA for a direct-to-consumer version of that test to be sold directly to consumers online.

Retailing at $39.99, the kit can be purchased without a prescription by any person age 18 or older, including for asymptomatic screening use. To purchase the kit, the customer must first register on Amazon’s AmazonDx.com diagnostic portal using an Amazon account. Registered users can also watch a video demonstrating how to use the kit, which comes with a nose swab, collection tube and a specimen bag. Delivery can be made in as little as one day in some areas. Once they collect the samples, users ship them to an STS Lab Holdco lab using the prepaid shipping label for processing, with results delivered directly via text or internet.

The Amazon test is also authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in pooled samples containing up to five individual anterior nasal swab specimens per pool that are collected in individual vials containing transport medium.

The Amazon website also sells direct-to-consumers COVID-19 tests from other companies ranging from Quidel’s QuickVue rapid test for $24.95 to a 10-pack of EmpowerDX’s self-collected PCR test kits at a price of $890.

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

STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS

Partner 1 Partner(s) 2+ Deal Summary
Cytox Infinity BiologiX
  • Objective: Launch new liquid biopsy-based lab developed test for Alzheimer’s disease risk in US
  • Dynamic: Test based on Cytox’s GenoScore platform for predicting risk of cognitive decline due to Alzheimer’s from a saliva or blood sample
  • IBX to offer test out of its CLIA-certified, CAP-accredited lab
G42 Healthcare Seegene
  • Objective: Provide fully equipped mobile diagnostics labs in Middle East and North Africa
  • Dynamic: Offer Seegene’s Mobile Station, a laboratory-on-wheels facility for molecular diagnostic testing that includes equipment, RT-PCR reagents, consumables, IT solutions and technical support
Berry Oncology Alibaba Health (part of Alibaba Group)
  • Objective: Develop early cancer screening and healthcare platform
  • Dynamic: Offer Berry Oncology’s Lai Si Ning NGS-based liver cancer screening test to people at high risk
  • Firms also offering medical insurance and cancer screening consultancy to liver disease patients via Alibaba’s Taobao e-commerce platform
OncoDNA Institut Jules Bordet
  • Objective: Perform study on central nervous system metastases
  • Dynamic: BrainStorm study to enroll 600 patients newly diagnosed with solid tumors at clinical sites in France, Belgium and Luxembourg
Quest Diagnostics Epizyme the
  • Objective: Improve access to EZH2 mutation testing for patients with relapsed or refractory follicular lymphoma
  • Dynamic: EZH2Now Testing Program to provide free testing to qualified patients
Enzo Biochem CLX Health
  • Objective: Provide rapid COVID-19 PCR testing for international travel
  • Dynamic: CLX Health to add Enzo’s test processing locations in New York and New Jersey to its cloud-based TrustAssure platform enabling travelers to schedule COVID-19 testing at convenient locations convenient, get and transmit their results to their airline
BGI Americas Champions Oncology
  • Objective: Provide proteomics and multiomics tools for cancer biomarker discovery and validation
  • Dynamic: BGI to handle sample preparation and do mass spectrometry analysis of Champions’ patient-derived xenograft samples to support biopharma drug discovery and development projects
Oncocyte Echelon Diagnostics
  • Objective: Develop analytical software to support commercial expansion of Oncocyte’s tests
  • Dynamic: Leverage Echelon’s AI imaging and big data solutions for molecular diagnostic technologies to support a pipeline of oncology diagnostic assays Oncocyte has acquired via acquisitions of other companies
Oncocyte Gruppo Oncologico del Nord-Ovest (GONO Foundation)
  • Objective: Evaluate Oncocyte’s immunotherapy response predictor DetermaIO in metastatic colorectal cancer
  • Dynamic: DetermaIO measures expression of genes thought to play a role in interaction between a tumor and its immediate microenvironment
Caris Life Sciences Elevation Oncology
  • Objective: Identify oncogenic fusions and mutations and develop therapeutics targeting these newly identified alterations
  • Dynamic: Examine Caris’ whole exome and transcriptome sequencing data on an ongoing basis, identify and evaluate potential new drug targets and then decide whether to initiate novel drug discovery programs or pursue licensing or product acquisitions
Quidel Mecwins
  • Objective: Develop next-generation point-of-care testing instrument
  • Dynamic: Combine Mecwins’ AVAC sensitive, high-throughput technology with Quidel’s expertise in cartridge and immunoassay design
Celemics Strand Life Sciences
  • Objective: Develop single, comprehensive technology platform to support bioinformatics research
  • Dynamic: Combine Celemics’ bioinformatics pipeline with Strand’s StrandOmics tertiary analysis platform to create integrated offering that includes assay-specific variant filters to provide “guaranteed” clinical-grade data compliance for cancer and rare diseases research
Twist Bioscience Regeneron Pharmaceuticals (via Regeneron Genetics Center subsidiary)
  • Objective: Develop a custom next-generation sequencing genotyping assay for population genetics
  • Dynamic: Twist to market the Diversity SNP Panel worldwide
Veranome Biosystems Portal Bioscience
  • Objective: Develop new spatial transcriptomics products for cancer and other complex disease research
  • Dynamic: New products will use Veranome’s high-definition imaging and data analysis technologies with Portal’s Proxal probe ligation-based biochemistry to enable tracking of fragmented RNA, as well as detection of mutations, gene fusions and splice variants
Biocept Cleared4
  • Objective: Develop system for tracking and managing COVID-19 testing requirements and test results for Biocept customers
  • Dynamic: Service to use Cleared4’s health platform, allowing Biocept COVID-19 testing clients to incorporate customized protocols and requirements
  • Platform to integrate results from Biocept’s RT-PCR-based COVID-19 testing in real time, and administrators will be able to monitor the program via a secure dashboard
LivFul Global Access Diagnostics
  • Objective: Offer rapid SARS-CoV-2 antigen test developed by Mologic at affordable prices in lower income countries
  • Dynamic: Plan is to expand collaboration to other diagnostics later
Akoya Biosciences AstraZeneca
  • Objective: Develop predictive assays and analysis frameworks to enable AstraZeneca and pharmaceutical industry to advance a spatial biomarker-informed drug development strategy for immunotherapy
  • Dynamic: Study drug mechanisms of action, confirm prevalence of targets and discover predictive signatures for trial designs using Akoya’s Phenoptics platform and Advanced Biopharma Solutions services
Nucleix University of Texas MD Anderson Cancer Center
  • Objective: Evaluate and develop methylation assays focusing on lung cancer
  • Dynamic: Research and license agreement under which firms will evaluate methylation markers for characterizing lung cancer subtypes. using Nucleix’s EpiCheck liquid biopsy platform
  • MD Anderson to validate the assays
Centogene Alector
  • Objective: Perform observational study to identify frontotemporal dementia patients with genetic mutations
  • Dynamic: Alector, a San Francisco-based immuno-neurology company developing treatments for neurodegenerative diseases, to provide undisclosed financial support for EFRONT study
Genomenon Nostos Genomics
  • Objective: Integrate Genomenon’s Mastermind genomic search engine into Nostos AIon AI-driven variant interpretation platform to improve diagnosis of rare genetic diseases
  • Dynamic: Integration will allow AIon users to preview lists of published articles related to their searches from within the AIon interface
Illumina Belgian Genetic Centers
  • Objective: Evaluate whole-genome sequencing to diagnose patients with intellectual disabilities and developmental disorders in routine care
  • Dynamic: Belgian Resolve Rare Diseases group to run a study recruiting 800 pediatric patients and their parents

DISTRIBUTION, SALES & MARKETING AGREEMENTS

Product Owner Distributor Deal Summary
Aiforia Epredia
  • Products: Aiforia’s artificial intelligence-based pathology software
  • Territory: Global
  • Exclusive rights in globally, with exclusive rights in Japan, Germany, UK, Italy, Spain, Sweden, Norway, Denmark, Iceland, France, US
Avacta Calibre Scientific
  • Products: Avacta’s AffiDX SARS-CoV-2 antigen lateral flow test
  • Territory: UK and European Economic Area
  • Nonexclusive
JADBio Qiagen
  • Products: JADBio’s automated machine learning platform
  • Territory: Undisclosed
  • Qiagen to distribute platform within its Digital Insights portfolio
InBios International Code 1 Supply
  • Products: InBios International’s point-of-care SCoV-2 Ag Detect Rapid Test for SARS-CoV-2 antigens
  • Territory: Undisclosed
Genetic Analysis Eagle Biosciences
  • Products: Genetic Analysis’ GA-map Dysbiosis Test
  • Territory: US and Canada
Shoreline Biome Inqaba Biotechnical Industries
  • Products: Shoreline Biome’s microbiome research products and services
  • Territory: Sub-Saharan Africa
Microbix Biosystems SDT Molecular
  • Products: Microbix’s quality assessment products, or QAPs
  • Territory: Hong Kong, Indonesia, Malaysia, Singapore
Euformatics A&C Group
  • Products: Euformatics’ Omnomics interpretation and validation software for next-generation sequencing
  • Territory: Bolivia, Peru, Paraguay

LICENSES

Licensor Licensee Deal Summary
Guardant Health Foundation Medicine Roche subsidiary pays $25 million plus royalties on future sales of Foundation’s liquid biopsy products for nonexclusive license to Guardant’s digital sequencing technology patents in agreement to settle Guardant’s patent lawsuits against Foundation
221b Foundation (nonprofit organization established by Sherlock Biosciences) Rokline Health Concepts Rokline gets non-exclusive license to SHERLOCK (Specific High Sensitivity Enzymatic Reporter unLOCKing technology), which uses CRISPR for amplicon detection for single-molecule detection of nucleic acid targets to develop COVID-19 tests

SUPPLY, SERVICE, TESTING & MANUFACTURING AGREEMENTS

Supplier/Servicer Client/User Deal Summary
Becton Dickinson USA Track & Field Becton Dickinson to provide rapid COVID-19 testing for USATF athletes with BD Veritor Plus system during Olympics qualifying events and trials

GOVERNMENT CONTRACTS

Contractor Govt. Agency Contract Summary
Leidos US Centers for Disease Control and Prevention Five-year contract worth up to $13 million for Leidos to provide IT and analytics support and management of very large datasets work to CDC’s Office of Advanced Molecular Detection
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