At-home COVID-19 testing and sample collection is becoming so big that it’s drawing players from outside the lab testing market. And it’s not just the Walgreens, Walmarts, Amazons and other retailers that have been established in the direct-to-consumer (DTC) diagnostics market well before the pandemic began. Among the most recent of the new arrivals to the DTC at-home COVID testing space is Uber. On April 26, the health care arm of the omnipresent rideshare company announced that it’s teaming up with Clinical Enterprise, Inc. d/b/a empowerDX, a US subsidiary of Luxembourg-based Eurofins Clinical Diagnostics, to provide on-demand delivery service of at-home COVID-19 testing kits to consumers.
The empowerDX-Uber Collaboration
empowerDX is an online shop affiliated with CLIA-certified clinical labs in the US that offers at-home testing for men’s and women’s health, sexual health and general wellness. It’s owner, Eurofins, was one of the many DTC businesses to expand into COVID-19 in response to the pandemic. Developed by the company’s Eurofins Viracor infectious disease testing lab, the empowerDX At-Home COVID-19 PCR Test Kit received Emergency Use Authorization (EUA) from the FDA on Oct. 15 for home collection and maintenance of nasal swab specimens to detect RNA from the SARS-CoV-2 virus. Four months later, the agency expanded the kit’s EUA to include DTC use and screening.
The company claims that as of December 2020, the assay offers one of the best sensitivity rates of the 117 labs that submitted results to the FDA’s SARS-CoV-2 Reference Panel. The empowerDX at-home test kit, which is 100 percent covered by most insurance carriers, includes step-by-step instructions, a shallow nasal swab, test tube and a pre-paid FedEx package for easy sample returns. Consumers need to activate their kits online before taking the test. Test results are delivered to a secure patient portal within an average of 24 to 48hours from sample receipt at the company’s CLIA-certified lab.
Starting in May, consumers in more than two dozen US cities, including Houston, Austin, Seattle, Denver, Phoenix, Minneapolis, Tampa and Fort Lauderdale, will be able to order the kit directly from empowerDX website without a prescription. Uber will make the kit available for delivery, hopefully in as little as one hour, from Monday through Friday between 8 AM and 4 PM. If the project proves successful, the companies plan to expand it to additional cities in the coming weeks.
Here’s a summary of other key strategic diagnostic deals announced in April 2021:
STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS
| Partner 1 |
Partner(s) 2+ |
Deal Summary |
| llumina |
Kartos Therapeutics |
- Objective: Develop next generation sequencing-based (NGS) TP53 companion diagnostic based on Illumina’s TruSight Oncology 500 (TSO 500) pan-cancer comprehensive genomic profiling assay
- Dynamic: Initial focus to be developing companion diagnostic for Kartos’ MDM2 inhibitor, KRT-232
|
| Biocartis |
SkylineDx |
- Objective: Develop SkylineDx’s Merlin assay to predict melanoma patient risk of nodal metastasis on Biocartis Idylla platform
- Dynamic: SkylineDx to lead assay development and Biocartis to use its Idylla network to commercialize assay in Europe
|
| Prevencio |
Atlas Genomics |
- Objective: Commercialize Prevencio’s artificial intelligence-based HART cardiac blood tests
- Dynamic: Seattle-based CLIA lab Atlas Genomics to commercially launch HART tests for patient use on Microsoft secure cloud
|
| Siemens Healthineers |
Biognosy |
- Objective: Discover and develop protein biomarkers
- Dynamic: Use Biognosys’ mass spectrometry technology to discover novel biomarkers, which they will then validate for potential clinical applications
- Project to be run out of Siemens Healthineers’ California clinical lab
|
| Amgen |
NeoGenomics |
- Objective: Expand biomarker testing access to all advanced or metastatic non-small cell lung cancer (NSCLC) patients
- Dynamic: Launch new Biomarker Assist project consisting of 2 parts: i. Next-Generation Sequencing Affordability Program under which Amgen to cover costs of comprehensive biomarker panels to advanced NSCLC patients; and ii. KRAS Single Gene Test Program under which Amgen to cover cost of NeoGenomics’ single-gene tests for KRAS G12C driver mutation for all advanced or metastatic NSCLC patients
|
| OncoDNA |
Institut Curie (France) |
- Objective: Evaluate liquid biopsy-based treatment monitoring for head and neck cancer patients
- Dynamic: Integrate OncoDNA’s OncoFollow blood-based NGS test into Institut Curie’s ongoing prospective biobanking SCANDARE study
|
| Antelope Dx |
In The Pocket +Extra Horizon |
- Objective: Develop an app and cloud-based services for Antelope’s self-tests
- Dynamic: In The Pocket to develop the app, which will guide user through self-test process, provide test result, and propose “useful next steps”
- Extra Horizon to develop cloud-based component of app to ensure safe management of data and regulatory compliance
|
| Centogene |
Takeda Pharmaceutical Company |
- Objective: Diagnose patients with certain genetic disorders
- Dynamic: 2-year renewal of existing global partnership made in 2015
|
| Invitae |
PTC Therapeutics |
- Objective: Offer free genetic testing to US patients with symptoms or a diagnosis of cerebral palsy and no evidence of brain injury
- Dynamic: Under newly launched PTC Pinpoint Direct-CP Spectrum program Genome Medical to provide genetic counseling and administration and Invitae to do the genetic testing
|
| Twist Bioscience |
Pure Biologics (Poland) |
- Objective: Discover, validate and optimize new antibody candidates against useful targets for immunoncology applications
- Dynamic: Twist’s biopharma division to give Pure Biologics access to select synthetic antibody phage display libraries
- Pure Biologics tp pay Twist annual technology access fees and future payments for preclinical, clinical and commercial milestones on any antibodies resulting from collaboration
|
| Agena Biosciences |
Ethos Laboratories |
- Objective: Use Agena’s MassArray MALDI-TOF platform for high-throughput detection of SARS-CoV-2 variants
- Dynamic: Ethos to use Agena platform to simultaneously detect, identify and report variants in as little as 6 hours at lower cost and higher throughput than NGS methods
|
| Genomenon |
Limbus Medical Technologies |
- Objective: Integrate Genomenon’s Mastermind genomics literature search engine into Limbus’ Varvis genomics-based clinical diagnostics decision support system
- Dynamic: Current integration allows Varvis users to preview published articles relevant to their search but requires that they click over to Mastermind to read them
- Firms to create a deeper link with Mastermind’s application programming interface to make full text available within Varvis
|
| Abcam |
MEDx Translational Medicine (China) |
- Objective: Develop new cancer diagnostics for China market
- Dynamic: Expand current alliance covering companion diagnostic and in vitro diagnostic reagents and kits for cancer genes pan-NTRK and dMMR to products for other indications
|
| Trapelo Health |
Magellan Rx Management (pharmacy benefits management arm of Magellan Health) |
- Objective: Build platform to support value-based precision oncology care
- Dynamic: Bundle Trapelo’s clinical decision support system for utilization of molecular testing with Magellan’s oncology management services helping payors with prior authorization, customized formulary management, personalized dosing, patient care management and post-service claim edits
|
| Proscia |
Unilabs |
- Objective: Accelerate use of artificial intelligence in routine pathology practice
- Dynamic: Unilabs to validate efficacy of Proscia’s computational pathology applications and deploy them into its high-throughput pathology workflows
- Partners also to create de-identified datasets, while adhering to data protection regulations
|
| Concentric by Ginkgo (part of Ginkgo Bioworks) |
Dascena Labs |
- Objective: Offer scalable pooled COVID-19 testing for K-12 schools
- Dynamic: Perform pooled classroom testing, combining samples from all consenting people in a classroom and running them as a single test to increase testing capacity and cut costs
- Cocentric by Ginkgo also announced similar pooled school testing partnerships with Olive Labs and CQuentia
|
DISTRIBUTION, SALES & MARKETING AGREEMENTS
| Product Owner |
Distributor |
Deal Summary |
| PixCell Medical |
Axonlab |
- Products: PixCell’s HemoScreen point-of-care hematology analyzer
- Territory: Switzerland, Austria, Netherlands, Czech Republic
|
| GenScript BioTech BV |
IES Diagnostics |
- Products: GenScript cPass SARS-CoV-2 Neutralization Antibody Detection Kit
- Territory: Spain, Portugal, Andorra
- Exclusive
|
| Congenica |
Camtech Diagnostics |
- Products: Congenica’s clinical decision support platform
- Territory: Singapore, Malaysia, Japan, South Korea
|
| Avacta |
Abcam |
- Products: Avacta’s SARS-CoV-2 ELISA spike protein Affimer research reagents
- Territory: Global
- Non-exclusive
|
LICENSES
| Licensor |
Licensee |
Deal Summary |
| 221b Foundation (nonprofit organization established by Sherlock Biosciences) |
Cooper International |
Cooper International 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 |
| 221b Foundation |
United PPE |
United PPE 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 |
| ERS Genomics |
Nuvisan |
Bayer spinoff gets non-exclusive license to ERS’ CRISPR-Cas9 patent portfolio Nuvisan allowing the firm access to ERS' CRISPR-Cas9 patent portfolio to help advance its clients’ drug discovery and early development programs |
| University of Manitoba |
Health Logic Interactive |
Exclusive license to UAL-Chip lab-on-a-chip technology for use to develop handheld device providing rapid diagnosis of chronic kidney disease at home and at point of care |
SUPPLY, SERVICE, TESTING & MANUFACTURING AGREEMENTS
| Supplier/Servicer |
Client/User |
Deal Summary |
| BioReference Laboratories (part of Opko Health) |
Major League Baseball |
BioReference to provide on-site, rapid PCR, point-of-care COVID-19 testing using Mesa Biotech’s Accula system for all 30 teams during 2021 season |
| Arrow Diagnostics (Italian subsidiary of Seegene) |
Italian Department of Defense |
$107 million contract to supply approximately 7.15 million COVID-19 diagnostic tests and extraction reagents to the Ministry’s Extraordinary Commissioner for COVID-19 Emergency agency |
| Agilent Technologies |
Oxford BioDynamics |
Agilent to supply a custom-made SurePrint G3CGH Microarray for OBD’s research-use-only kit, which will include OBD’s 3D Genome Probes with OBD holding the kit’s exclusive supply and distribution rights |
