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

by Glenn S. Demby | Jul 11, 2021 | Articles, Deals-lir, Essential, Laboratory Industry Report

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 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	colheader
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

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

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