Home 5 Articles 5 Global Non-Profit & Smartphone DX Firm to Create Malaria Diagnosis App

Global Non-Profit & Smartphone DX Firm to Create Malaria Diagnosis App

by | Jul 17, 2020 | Articles, Deals-lir, Laboratory Industry Report

Malaria continues to wreak havoc around the world, particularly in low- and middle-income countries (LMICs). Although rapid in vitro diagnostic tests (RDTs) for malaria are widely used in those countries, implementation of malaria RDTs has been linked, in cases with negative malaria results, to an increased use of antibiotics. Moreover, analysis of malaria RDT results […]

Malaria continues to wreak havoc around the world, particularly in low- and middle-income countries (LMICs). Although rapid in vitro diagnostic tests (RDTs) for malaria are widely used in those countries, implementation of malaria RDTs has been linked, in cases with negative malaria results, to an increased use of antibiotics. Moreover, analysis of malaria RDT results is tricky and prone to a high rate of error by lab workers. But now a global non-profit and producer of smartphone-based, at-home diagnostics have embarked on a new project designed to remedy that problem.

The Partners

The Foundation for Innovative New Diagnostics (FIND) is a global non-profit organization that works with researchers, DX companies and regulators to facilitate the creation and distribution of diagnostics tools targeting six areas of major disease in LMICs.

Los Angeles-based Scanwell Health creates smartphone-enabled, at-home diagnostics for acute illnesses, chronic diseases and rare conditions, including the first and only over-the-counter app for urinary tract infection testing and treatment cleared by the FDA. The firm is also awaiting emergency use authorization from the FDA for an at-home SARS-CoV-2 test based on proprietary technology for interpreting lateral flow results.

The Partnership

The objective of the partnership, which was signed last in 2019, is to develop a smartphone app that uses machine learning and computer vision algorithms to read RDTs for malaria that healthcare professionals in those countries can use to interpret and record test results easily and more accurately to identify the specific malaria strain and determine the appropriate treatment. Based on the same lateral-flow test technology used by the Scanwell at-home SARS-CoV-2 test, the malaria app will be compatible with multiple RDT and mobile device brands and types, and thus suitable for broad use in LMICs.

The Scanwell app will also support on-the-ground data collection and feed into regional and national digital surveillance systems designed to help combat antimicrobial resistance (AMR). AMR, which undermines the efficacy of antibiotics, is of disproportionately greater concern in LMICs, where health systems tend to be weak, resources are often in short supply and “just in case” prescribing of antibiotics is common.

The partners expect to complete evaluation of the app and make it available in at least two to three LMICs this year. The implementation will focus on connecting this app with existing digital tools at a community healthcare level and national surveillance systems for monitoring AMR.

The End Game

“Malaria elimination and robust disease surveillance both depend on point-of-care testing that can be performed at the lowest levels of the healthcare system,” noted FIND CEO Catharina Boehme, CEO of FIND. “Using technology to optimize the use of RDTs for better patient care, while also enabling the collection of critical data to inform policy decisions on AMR strategies—and potentially also pandemic response—is a double win.”

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

Partner 1Partner(s) 2+Deal Summary
Thermo Fisher ScientificDaiichi Sankyo
  • Objective: Develop companion diagnostic for patients with non-small cell lung cancer (NSCLC)
  • Dynamic: Assay to use Thermo Fisher’s Oncomine Dx Target sequencing test to identify NSCLC patients with mutations in HER2 who may be eligible for treatment with Enhertu (DS-8201), a HER2-directed antibody-drug-conjugate that Daiichi is developing
Thermo Fisher ScientificGenetron Health
  • Objective: Commercialize next-generation sequencing-based (NGS) diagnostics in China
  • Dynamic: Bring Genetron S5, which is based on Thermo Fisher’s Ion GeneStudio S5 instrument for targeted NGS, to China public hospitals for cancer diagnostics, genetic disease diagnosis, microbial testing and reproductive health testing
Thermo Fisher ScientificAgios Pharmaceuticals
  • Objective: Codevelop companion diagnostic test to identify low-grade glioma patients with IDH1 and IDH2 mutations eligible for Agios’ investigational inhibitor vorasidenib
  • Dynamic: Expand current collaboration with Thermo Fisher to retain global commercialization rights to commercialize the test globally and take lead in seeking regulatory clearances
NuProbeWeigao Group
  • Objective: Develop liquid biopsy NGS panel for NSCLC for Chinese market
  • Dynamic: Leverage NuProbe’s blocker displacement amplification (BDA) technology to create product compatible with available desktop NGS instruments, and competitive in terms of sensitivity
ArcherDxBristol Myers Squibb
  • Objective: Use ArcherDx’s personalized cancer monitoring (PCM) assays for minimal residual disease (MRD) detection in cancer patients treated with immunotherapy
  • Dynamic: Evaluate clinical samples from cancer-patient cohorts to advance MRD detection or ctDNA clearance to potentially inform future therapy selection and/or optimization
  • Objective: Develop assays to detect MRD in early-stage NSCLC patients
  • Dynamic: ArcherDx to perform exome sequencing of samples and generate patient-specific, research-use-only circulating tumor DNA assays for use in AstraZeneca’s new Phase III MERMAID-1 trial evaluating effect of adjuvant treatment with durvalumab (Imfinzi) plus chemotherapy versus chemotherapy alone on disease-free survival
Canopy BiosciencesOnRamp Bioinformatics
  • Objective: Offer OnRamp’s Rosalind cloud-based genomic informatic platform to contract research organizations using Canopy’s gene expression services
  • Dynamic: Expansion of current partnership enabling Canopy customers to use Rosalind to visualize differential gene expression data from NanoString and RNA sequencing files, even if they lack other bioinformatics capabilities
  • Objective: Expand global access to SpeeDx’s infectious disease and antibiotic resistance tests
  • Dynamic: Non-exclusive agreement giving Roche access to SpeeDx’s tests and technology, including new ones for managing antibiotic resistance in sexually transmitted infections
Dante LabsCambridge Cancer Genomics + Nonacus
  • Objective: Develop high-throughput cancer sequencing and interpretation service for tumor profiling
  • Dynamic: Service to combine Dante Labs’ experience in sequencing services for solid tumor and cell-free circulating tumor DNA from liquid biopsies with Nonacus’ targeted pan-cancer NGS libraries and CCG.ai’s AI-based software platform, OncOS
Foundation for Innovative New DiagnosticsScanwell Health
  • Objective: Develop smartphone app to interpret rapid malaria diagnostic tests
  • Dynamic: Use Scanwell technology using machine learning and computer vision algorithms to read rapid in vitro diagnostic tests for an app compatible with many types of mobile devices and tests
Twist BioscienceSerimmune
  • Objective: Identify and evaluate antibody candidates for SARS-CoV-2 therapy
  • Dynamic: Evaluate existing Twist antiboides using Serimmune’s Serum Epitope Repertoire Analysis platform
MilliporeSigma10x Genomics
  • Objective: Develop single-cell CRISPR screening workflows
  • Dynamic: Workflows to combine MilliporeSigma’s CRISPR genome editing reagents with 10x’s Feature Barcode assay to enable single-cell screens for changes in gene expression
Avalon GloboCareGensKey Medical Technology
  • Objective: Commercialize point-of-care antibody and PCR tests for SARS-CoV-2
  • Dynamic: Both tests have received CE-IVD marking and awaiting FDA Emergency Use Authorization (EUA)
Sherlock BiosciencesIntegrated DNA Technologies
  • Objective: Manufacture Sherlock’s CRISPR SARS-CoV-2 testing kits on large scale
  • Dynamic: Kit, the first CRISPR-based diagnostic test to receive EUA for SARS-CoV-2 detection, provides specific and sensitive detection of virus in patient samples without need for specialized instruments
Life Science Biosensor Diagnostics (iQX subsidiary)Harvard University’s Wyss Institute for Biologically Inspired Engineering
  • Objective: Develop SARS-CoV-2 antibody test
  • Dynamic: Conductpilot study to integrate LSBD’s Biosensor platform with an assay system developed by Wyss Institute to detect IgM or IgG antibodies against SARS-CoV-2
Prescient MetabiomicsHarvard’s TH Chan School of Public Health
  • Objective: Investigate microbiome biomarkers in colon cancer
  • Dynamic: Study use of microbial biomarkers to identify precancerous adenomas and carcinomas in the colon
Takara Bio USABioSyntagma
  • Objective: Develop and validate a high-throughput SARS-CoV-2 detection method
  • Dynamic: Method uses Takara Bio’s SmartChip PCR instrument, chips and reagents to run 5,184 reactions per chip in less than 30 minutes of direct hands-on time
Swift BiosciencesArbor Biosciences (division of Chiral Technologies)
  • Objective: Provide complete workflow for RNA-seq library preparation and targeted enrichment of SARS-CoV-2 genome
  • Dynamic: Combine Swift’s patented Adaptase technology and RNA library kits with Arbor’s myBaits technology for hybridization-based target enrichment of virus for whole-genome sequencing
  • Objective: Produce and comarket enzymes for life science and diagnostic applications
  • Dynamic: Alphazyme to be exclusive manufacturer of three Codexis-developed enzymes
  • Alphazyme also gets comarketing rights to certain Codexis enzymes
IlluminaGenomic Medicine Sweden
  • Objective: Assess whether whole-genome sequencing and RNA sequencing can replace conventional first-line clinical diagnostic methods for acute leukemia
  • Dynamic: Conduct nationwide study of about 450 patients
BioGXBosch Healthcare Solutions
  • Objective: Develop point-of-care infectious disease tests for Bosch’s Vivalytic platform
  • Dynamic: BioGX to develop, manufacture + supply reagents for Vivalytic cartridges and provide custom reagent manufacturing services for Vivalytic open system users
Property OwnerDistributorDeal Summary
Lunaphore TechnologiesEpredia
  • Products: LabSat Research platform for rapid immunohistochemistry and immunofluorescence
  • Territory: US, UK, Germany
  • Non-exclusive
  • Distribution to begin in Japan in 2021
NLC PharmaTodos Medical
  • Products: NLC Pharma’s 3C protease diagnostic platform for SARS-CoV-2
  • Territory: Israel
  • Exclusive
Healgen ScientificMenarini Silicon Biosystems
  • Products: Healgen’s COVID-19 IgG/IgM Rapid Test Cassette antibody detection kit
  • Territory: US
  • Non-exclusive
Sienna Cancer DiagnosticsTriolab
  • Products: Sienna’s hTERT bladder cancer test
  • Territory: Sweden
  • Exclusive
MedMiraWebb Diagnostic Technologies
  • Products: MedMira’s RevealCOVID-19 Total Antibody Test
  • Territory: Canada
  • Webb Diagnostic has placed initial order worth about $2.5 million
LicensorLicenseeDeal Summary
St. Jude Children’s Research HospitalBioSkryb
  • BioSkryb acquires exclusive rights to use diagnostic test to detect and define populations of cancer cells during treatment
Ohio State Innovation FoundationExagen
  • Exagen gets exclusive worldwide license agreement to develop and market  fibromyalgia blood test created by Ohio State
University of Illinois at Urbana-ChampaignModular Bioscience
  • Modular gets exclusive global patent license to an artificial restriction enzyme (ARE) platform developed by the University
Rice UniversityNuProbe
  • NuProbe gets exclusive global license to two oligonucleotide technologies developed by Rice
Supplier/ServicerClient/UserDeal Summary
GenMark DiagnosticsVidant Health
  • Quotient to be Vidant Health’s primary provider of rapid testing for SARS-CoV-2 and other infections

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