Diagnostics Deals

3M and MIT Team Up to Create Rapid, Scalable SARS-CoV-2 Antigen Test

Unlike reverse transcription-polymerase chain reaction (PCR) and blood-based serology antibody assays, antigen tests are relatively inexpensive to produce and generate results rapidly at the point of care. This combination of scalability and speed makes antigen testing a potential solution to the urgent need for high throughput SARS-CoV-2 testing. The problem is that development of antigen tests currently lags behind PCR and serology tests. But now a pair of powerhouses, one from the corporate and the other from the academic world, are setting out to close the gap and bring SARS-CoV-2 tests to market on a massive scale.

The 3M-MIT Collaboration

On July 14, 3M and the Massachusetts Institute of Technology (MIT) announced that they are developing a rapid SARS-CoV-2 antigen test. The collaboration combines an MIT research team which specializes in creating and developing molecular technologies to boost performance of rapid cellulose-based protein tests with a 3M team led by scientists, manufacturers and regulatory experts from the company’s corporate research laboratories and healthcare business group.

And there’s a third partner, namely, the US National Institute of Health (NIH), which has provided initial funding of $500,000 under its new Rapid Acceleration of Diagnostics Tech (RADx) program to support “aggressively-paced COVID-19 diagnostics.” The researchers will qualify for additional RADx funding if they can demonstrate the test’s feasibility and commercialization potential after a four-week research period.

The Test

The 3M-MIT SARS-CoV-2 antigen test is designed to use a paper-based device to deliver test results within minutes at the point of care. When and if the test is validated, the researcher believe that it can be scaled to produce millions of units per day.

The Upside

“Antigen tests are important in the overall response against COVID-19 as they can generally be produced at a lower cost than PCR tests,” according to FDA Commissioner Stephen Hahn. “And once multiple manufacturers enter the market, antigen tests can potentially scale to test millions of Americans per day due to their simpler design, helping our country better identify infection rates closer to real time.”

The downside of antigen tests is that they’re less sensitive than PCR assays, which makes them prone to false negatives. Accordingly, patients who test negative may need to have confirmatory PCR tests. But while PCR testing may be the gold standard for COVID-19 testing accuracy, it’s not a high-throughput modality. In spite of its accuracy limitations, antigen testing may have to be relied on to meet the unprecedented demand for testing, especially for applications like screening health care workers and other high-risk groups and triaging patients during peak outbreak periods the way rapid influenza diagnostic tests are used during a bad flu season.


Here’s a summary of other key strategic diagnostic deals announced in July 2020:

STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS
Partner 1 Partner(s) 2+ Deal Summary
3M Massachusetts Institute of Technology
  • Objective: Developing rapid antigen test for SARS-CoV-2
  • Dynamic: Viral antigen test would provide test results within minutes using a paper-based device at the point of care and be scaled to produce millions of units per day
Centogene Molecular Health
  • Objective: Develop new orphan drugs, starting with epilepsy
  • Dynamic: Carry out project called Real-life data and Innovative Bioinformatic Algorithms (RIBA) combining Centogene’s real-life data sets in rare diseases with Molecular Health’s expertise in big data, AI and computational algorithms
MP Biomedicals Asia Pacific Singapore’s Agency for Science, Technology and Research (A*STAR)
  • Objective: Develop point-of-care antibody test for SARS-CoV-2
  • Dynamic: Test has provisional regulatory authorization in Singapore regulators and is being distributed in Europe, Africa and South America with plans to seek EUA from FDA
Ultivue OracleBio
  • Objective: Offer pharmaceutical companies end-to-end workflow for tissue-based biomarker analysis
  • Dynamic: Firms to combine respective technologies for tissue staining and histopathology image analysis
BostonGene NEC
  • Objective: Analyze molecular profiles and tumor microenvironments of cancer patients in NEC’s clinical trials to improve cancer treatment response
  • Dynamic: BostonGene to perform integrated genomic and transcriptomic next-generation sequencing on tumors of select patients across different cancer types and disease stages and analyze tumor microenvironment activity
Saga Diagnostics SensID
  • Objective: Develop control reagents for cancer mutation detection
  • Dynamic: Use use SensID’s controls with Saga’s digital PCR-based Sagasafe technology for detecting and quantifying ctDNA in cancer patients at ultra-low allelic frequencies
Microba Synlab
  • Objective: Launch MyBiome gut microbiome test in Europe and Latin America
  • Dynamic: Test measures bacterial species in gut microbiome and calculates their metabolic potential in relation to healthy reference ranges
Helix San Diego County (California)
  • Objective: Provide COVID-19 molecular diagnostics tests
  • Dynamic: Provide up to 2,000 of Helix’s RT-qPCR assays per day out of Helix’s San Diego lab
Thermo Fisher Scientific First Genetics
  • Objective: Commercialize NGS-based diagnostics in Russia
  • Dynamic: First Genetics, a Russian manufacturer, to market its IVD assays and F-Genetics NGS System, which is based on Thermo Fisher’s Ion GeneStudio S5 sequencer, to Russian labs for reproductive health and cancer testing
Thermo Fisher Scientific Chugai Pharmaceutical (part of Roche group)
  • Objective: Develop CDx to identify ROS1-positive non-small cell lung cancer patients who may be eligible for treatment with entrectinib (Genentech’s Rozlytrek, marketed in Japan by Chugai)
  • Dynamic: Thermo Fisher to also seek Ministry of Health, Labor, and Welfare of Japan approval to expand use of Oncomine Dx Target test in Japan
Twist Bioscience Takeda Pharmaceutical Company
  • Objective: Develop new antibodies for oncology, rare disease, neuroscience and gastroenterology therapies
  • Dynamic: Twist to give Takeda access to its phage display libraries for use in discovery, validation and optimization of antibodies needed to develop new biologics in exchange for annual technology licensing fees, milestones and royalties for all compounds discovered from Twist libraries
Smiths Detection Attomarker
  • Objective: Develop and manufacture SARS-CoV-2 antibody testing device
  • Dynamic: Create miniaturized version of Attomaker Triple Antibody Test that works with smartphones to enable point-of-care and at-home testing
Guardant Health Janssen Biotech
  • Objective: Seek regulatory approval for and commercialize Guardant360 assay as CDx for amivantamab, Janssen’s investigational EGFR-MET bispecific antibody for treating non-small cell lung cancer
  • Dynamic: Agreement covers US, Canada, Japan and Europe
Myriad Genetics OptraHealth
  • Objective: Develop chatbot named Gene to offer patients hereditary cancer information
  • Dynamic: Gene to fuse OptraHealth’s GeneFax AI platform with Myriad’s online hereditary cancer quiz
Genomics England Amazon Web Services
+
Lifebit
  • Objective: Create platform for researching COVID-19 data and analytics
  • Dynamic: Include data from Genomics England’s research partnership with the Genetics of Mortality in Critical Care (GenOMICC) consortium, the NHS, and Illumina to sequence genomes from up to 35,000 SARS-CoV-2 patients
Proscia Royal Philips
  • Objective: “Advance an open ecosystem” to accelerate and scale adoption of digital pathology by labs
  • Dynamic: Integrate Philips’ image format with Proscia’s digital pathology platform
Pressure Biosciences (PBI) Leica Microsystems (part of Danaher)
  • Objective: Globally comarket mass spectrometry sample preparation platform
  • Dynamic: Platform combines Leica’s laser microdissection (LMD) technology for precise cutting of small biopsy samples, and PBI’s pressure cycling technology (PCT), for protein extraction and digestion from samples for mass spec analysis
Burning Rock Biotech CStone Pharmaceuticals
  • Objective: Co-develop and commercialize companion diagnostics for Blueprint Medicines’ pralsetinib in China
  • Dynamic: Firms to promote standardization of RET gene testing in China
DISTRIBUTION, SALES & MARKETING AGREEMENTS
Property Owner Distributor Deal Summary
Oncocyte ProGenetics
  • Products: Oncocyte’s DetermaRx test to identify patients at high risk for lung cancer recurrence who may benefit from adjuvant chemotherapy after tumor removal surgery
  • Territory: Israel
Menarini Silicon Biosystems OpGen
  • Products: Menarini’s Cellsearch Circulating Endothelial Cell (CEC) Kit
  • Territory: North America
3D Medicines Todos Medical
  • Products: 3D Medicines’ qPCR test kits and SARS-CoV-2 test
  • Territory: US
  • Todos gets exclusive right to seek FDA Emergency Use Authorization for test
LICENSES
Licensor Licensee Deal Summary
Massachusetts Institute of Technology PathSensors
  • Expands current exclusive license to CANARY pathogen detection technology to include clinical applications starting with SARS-CoV-2
Massachusetts General Hospital ProterixBio
  • ProterixBio licenses ELISA-based serology test measuring antibodies that bind to receptor binding domain of SARS-CoV-2 spike protein
NEW CLINICAL STUDIES
DX Partner Other Partner(s) Description of Study
BioReference Laboratories (Opko Health subsidiary) US Centers for Disease Control and Prevention
  • Indefinite Delivery Indefinite Quantity (IDIQ) contract to provide antibody testing for national SARS-CoV-2serological survey
Quidel US Department of Health and Human Services
  • HHS to purchase 2,000 Sofia and Sofia 2 instruments and 750,000 Sofia SARS Antigen FIA tests to detect SARS-CoV-2 in nursing homes
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