As schools return to in-person learning environments, communities across the country are turning to COVID-19 testing programs to monitor and contain the virus. Although, more and more teachers, parents and guardians become vaccinated against the virus clinical vaccine trials for individuals under 16 are just beginning, so testing to track and mitigate viral spread is critical.
Who’s Paying for School Testing
Funded by the $10 billion provided by the Biden administration for COVID-19 testing in K-12 schools and a new Rockefeller Foundation initiative to guide schools on providing COVID-19 testing, labs are partnering with Ginkgo Bioworks to ramp up testing. Quest Diagnostics, Dascena Labs, Helix, COuentia and Olive labs have all announced collaborations to provide COVID-19 testing services for K-12 students in the U.S. The labs are partnering with Ginkgo to provide free COVID-19 pooled testing services for every K–12 student each week.
“We are very excited to partner with Ginkgo on this highly important initiative as our country continues to work to recover from the ongoing COVID-19 crisis,” said James Wingrove, Ph.D., Chief Scientific Officer of Dascena, Inc., who oversees Dascena Labs in a
statement. “Enabling the safe return of children and teachers back to in-person learning is a crucial step in that recovery. By providing accessible and accurate testing to teachers and students, we hope, that together with Ginkgo, we can help to provide safe learning environments.”
Testing Services to Be Provided
Many of the deals call for testing on pooled samples, a testing protocol that the FDA is temporarily allowing to meet the unprecedented demand for COVID-19 testing. Ginkgo’s platform offers pooled testing, where 5 to 25 samples are pooled into one sample, to reduce the cost of testing without sacrificing accuracy. Children as young as kindergarten age swab their own noses. Ginkgo’s website notes that they currently provide their pooled testing service to 946 schools.
Concentric by Ginkgo is Ginkgo Bioworks, Inc.’s biosecurity and public health effort and a national testing provider for K-12 schools. Its goal is to provide easy, affordable pooled testing to every school in America. Ginkgo Concentric is currently running testing in more than 15 states in 800 schools.
Pooled classroom testing, which combines swabs from all consenting individuals in a classroom and runs them as a single test, is an effective way to significantly increase testing capacity and lower the cost of testing programs. For example, Ferndale, Michigan-based Olive Labs will perform the PCR testing and currently has a turnaround time of 24 hours, it said. The lab has scaled its testing equipment and has the capacity to “potentially test all the schools” in Michigan, it added.
The services are based on recommendations provided by the Rockefeller Foundation in its
K–12 National Testing Action Program: Connecting Schools with the Nation’s Leading Testing Companies to Safely Reopen (NTAP), which provides a testing roadmap for schools and cites both Quest and Ginkgo for their COVID-19 testing expertise.
Here’s a summary of other key strategic diagnostic deals announced in May 2021:
STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS
| Partner 1 |
Partner(s) 2+ |
Deal Summary |
| Qiagen |
Mirati Therapeutics |
- Objective: Develop tissue-based companion diagnostic test to identify cancer patients for adagrasib, Mirati’s investigational oral small molecule inhibitor of KRAS G12C
- Dynamic: Test to become part of Qiagen’s Therascreen KRAS testing portfolio
- Initial focus on CDx test for non-small cell lung cancer with possibility of expansion to other Mirati oncology programs
|
| Fujifilm Medical Systems USA |
Helio Health |
- Objective: Develop blood-based test for earlier detection of liver cancer
- Dynamic: Use Helio Health’s HelioLiver DNA methylation and biomarker-based blood test for detecting hepatocellular carcinoma — with Fujifilm’s μTASWako i30 immunoanalyzer
|
| Siemens Healthineers |
Genetron Health |
- Objective: Expand hospital use of Genetron’s S5 sequencing platform and 8-gene lung cancer IVD assay in China
- Dynamic: Partners to also work together to help standardize cancer molecular testing practices in hospitals in China
|
| Sciex |
Waters |
- Objective: Offer Sciex’s mass spectrometry systems fully configured and interoperable with Waters’ liquid chromatography instruments
- Dynamic: Collaboration will make it easier for Sciex mass spec customers to configure their systems with Waters’ UPLC instruments
|
| Quest Diagnostics |
Paige |
- Objective: Discover biomarkers for cancer and other diseases
- Dynamic: Leverage Paige’s AI and machine learning expertise of pathology diagnostic data for biomarker discovery and develop new tests and software products
|
| Quest Diagnostics |
CIC Health |
- Objective: Provide SARS-CoV-2 testing for K-12 schools, summer camps and other programs
- Dynamic: Quest to augment CIC Health’s lab network, which currently facilitates pooled COVID-19 testing for over 80 school districts and 600 schools across 20 states
|
| Quest Diagnostics |
Ginkgo Bioworks |
- Objective: Provide COVID-19 screening testing for grades K-12 to support in-class learning across U.S.
- Dynamic: Patterned after Ginkgo’s existing collaborations with other COVID-19 testing labs, including Dascena Labs, Olive Labs and Cqentia
|
| Watchmaker Genomics |
Molecular Loop have |
- Objective: Commercialize genetic tests for pathogen surveillance
- Dynamic: Combine Watchmaker’s expertise in computational biology, high-throughput enzyme engineering, and large-scale enzyme production with Molecular Loop’s molecular inversion probe (MIP)-based assays
|
| Exagen |
Allegheny Health Network Research Institute+AHN Autoimmunity Institute |
- Objective: Develop develop new patented biomarkers for diagnosis, prognosis and monitoring of autoimmune diseases
- Dynamic: Exagen to acquire a worldwide exclusive license to four families of inventions and access to Autoimmunity Institute’s clinical biobank
|
| Alzheon |
Institute of Organic Chemistry and Biochemistry of Czech Academy of Sciences (IOCB) |
- Objective: Develop test for Alzheimer’s disease
- Dynamic: IOCB to use Alzheon’s analytical chemistry technology to develop the test and Alzheon to commercialize it
|
| Bio-Techne |
908 Devices |
- Objective: Develop extended workflow for protein characterization
- Dynamic: Combine Bio-Techne’s Maurice icIEF protein separation instrument with 908 Devices’ ZipChip platform to enable in-depth characterization of intact and near-native biotherapeutics
|
| Echelon Diagnostics |
Cradle Genomics |
- Objective: Accelerate development of Cradle’s cell-based noninvasive prenatal diagnostic products
- Dynamic: EchelonDx to use its PrenatalDx technology to enhance data analysis and reporting capabilities of Cradle’s fetal genetic analysis and health screening solutions
|
| Inivata |
Agendia |
- Objective: Commercialize Inivata’s liquid biopsy assay for minimal residual disease detection in breast cancer
- Dynamic: Agendia to get co-exclusive rights to distribute Inivata’s RaDaR liquid biopsy assay for breast cancer detection in North America and Europe
- Agendia also gets option to extend the deal to additional territories later
|
| NuProbe |
AcornMed Biotechnology |
- Objective: Develop tests for minimal residual disease detection in genitourinary tract cancer and hematological cancer
- Dynamic: Leverage NuProbe’s blocker displacement amplification, or BDA, technology to create assays
|
| BostonGene |
Medical College of Wisconsin |
- Objective: Identify predictive biomarkers for pancreatic cancer
- Dynamic: Analyze whether patients’ pancreatic ductal adenocarcinoma unique tumor microenvironments affect their treatment responses
|
| Illumina |
Kartos Therapeutics |
- Objective: Develop NGS-based TP53 companion diagnostic
- Dynamic: Base test on Illumina’s pan-cancer comprehensive genomic profiling assay, TruSight Oncology 500 (TSO 500) for use to detect TP53 mutations in multiple hematologic indications
|
DISTRIBUTION, SALES & MARKETING AGREEMENTS
| Product Owner |
Distributor |
Deal Summary |
| Yourgene |
Alliance Global |
- Products: Yourgene’s noninvasive prenatal testing products, reproductive health tests and QS250 and LightBench enrichment technologies
- Territory: Middle East and Africa
|
| IsoPlexis |
Bucher Biotec |
- Products: IsoPlexis’ IsoLight and IsoSpark proteomics platforms
- Territory: Switzerland
- Exclusive
|
| Namocell |
SingLab Technologies |
- Products: Namocell’s single-cell isolation systems
- Territory: Singapore
|
| Euformatics |
Al-Jeel Medical and Trading Co. |
- Products: Euformatics’ Omnomics interpretation and validation software for next-generation sequencing
- Territory: Saudi Arabia
|
| Quidel |
McKesson |
- Products: Quidel’s QuickVue at-home COVID-19 test
- Territory: US
|
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 |
| 221b Foundation |
LogicInk |
LogicInk gets non-exclusive license to use SHERLOCK to develop instrument-free diagnostic biosensor for SARS-CoV-2 |
| ERS Genomics |
GenScript Biotech |
GenScript gets non-exclusive license to use ERS’ CRISPR-Cas9 patent portfolio to strengthen its own CRISPR-based services |
| Mayo Clinic |
Phenomix Sciences said on Tuesday that it has signed an |
Exclusive license to multiomics MyPhenome test blood test to predict obesity phenotypes |
| Harvard University |
Rhinostics |
Rhinostics licenses nasal swab collection technology developed at Harvard’s Wyss Institute |
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 |
| Hologic |
US Dept. of Defense |
$178.5 million firm-fixed-price Army contract for Hologic’s Panther Fusion SARS-CoV-2 assays, Aptima SARS-CoV-2 assays, multiplex test kits, and associated reagents and consumables |
