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Chembio Diagnostics Idea Proposal (CEMI)

Chembio Diagnostics Idea Proposal (CEMI)
 

How will sensitivity and specificity concerns impact adoption of COVID-19 point-of-care tests? Will Chembio’s DPP COVID-19 System gain and sustain commercial success?

Report Available: June 11, 2020

 

Blueshift’s initial research found the medical/pharma industrial complex engaging in a massive COVID-19 related effort to produce personal protective equipment, coronavirus testing systems and treatments. Over 180 companies are offering PCR and/or Serology testing systems. The FDA has been granting Emergency Use Authorization (EUA) to almost all comers in order to increase the number of people tested for both COVID-19 and its antibodies to help stop this pandemic. CEMI is one of the companies that received an EUA for its Serological DPP COVID-19 IgM/IgG System. The rapid response by test producers and the FDA has been impressive, however questions regarding the sensitivity, specificity, and accuracy of many tests are now being raised.

 

Observations

  1. Following the declaration of a public health emergencyon February 4 by the Secretary of Health and Human Services, the FDA has aggressively used its authority to grant EUAs to companies producing COVID-19 testing equipment and supplies to help rapidly increase patient testing. 360DX, a website that covers emerging economic and technological trends in the clinical diagnostic market, has a coronavirus test tracker which identifies over 180 companies with available tests, of which 74 PCR and 21 Serological tests have received EUA approval.
  2. As the FDA moved quickly to address the urgent public health need for additional COVID-19 testing by granting EUAs, test validation became the responsibility of the laboratory conducting the test and/or the manufacturer producing the equipment rather than the typical FDA verification process. As one would expect, questions and studies regarding the sensitivity, specificity, and accuracy of these rapidly produced tests are emerging. Some examples of recent headlines pointing to these issues include:
  • May 21, ABC News:Mayo Clinic doctors find many COVID-19 antibody tests fail their quality standards
  • May 19, Nexstar Media Wire: 33,000 Floridians who took COVID-19 test may have incorrect results
  • May 16, CNN: Why a positive Covid-19 antibody test doesn’t mean much of anything yet
  • May 14, Becker’s Hospital Review: There are limits to coronavirus antibody testing, AMA warns
  • April 21, NPR: Study raises questions about false negatives from quick COVID-19 test
  1. CEMI received FDA EUA and CE Marking for its DPP COVID-19 Point-of-Care IgM/IgG System on April 14 and May 4, respectively. The system is also approved for use in Brazil under ANVISA. CEMI’s rapid COVID-19 antibody test is a serological test and analyzer that provides numerical readings for both IgM and IgG antibody levels within 15 minutes from a simple finger stick drop of blood. The ability to provide numerical results aids clinicians in determining current or past exposure to the COVID-19 virus and monitoring infection progression while avoiding the human interpretation errors associated with visual readings. CEMI’s DPP point of care testing system has been consistently used for detection and diagnosis of infectious disease including Zika and Ebola.
  2. CEMI’s launch of its DPP COVID-19 Point-of-Care IgM/IgG System got off to a fast start having received a $4 million order from Bio-Manguinhos, a subsidiary of the Oswaldo Cruz Foundation (Fiocruz) that is responsible for the development and production of vaccines, diagnostics and biopharmaceuticals, to meet demands of Brazil’s national public health system. CEMI also recently signed a non-exclusive agreement with Thermo Fisher Scientific for the distribution of the DPP COVID-19 System in the U.S. Rick Eberly, CEMI’s president and CEO said, “Thermo Fisher Scientific will significantly increase our commercial footprint by providing access to thousands of hospital and physician-office moderately complex labs across the country.” A Blueshift source said the deal lends significant credibility to CEMI’s COVID-19 test system.

 

Are COVID-19 antibody point-of-care test sensitivity, specificity, and accuracy rates high enough to promote widespread use? Is there value in hospitals, medical practices, and clinics adopting any of the current tests? Will COVID-19 antibody tests become a part of the national effort to reopen the economy? Will employers of large numbers of workers consider a testing program? How does CEMI’s DPP COVID-19 Point-of-Care IgM/IgG System compare to the competition? Can CEMI’s test generate and sustain meaningful revenue? What are the headwinds facing CEMI and its antibody test? How important is CLIA approval to allow the CEMI test to be used in point of care settings? How does CEMI compare to Chinese competitor Innovata? To answer these and other questions, Blueshift will gather data and issue a market research report from independent sources in the following areas: Medical diagnostic experts, COVID-19 testing professionals, Diagnostic testing sales and distribution channels, and Industry specialists.  

 

Companies: Abbott Labs (ABT), Becton Dickinson (BDX), bioMerieux (OTC:BMXMF), Chembio Diagnostics Inc. (CEMI), Co-Diagnostics (CODX), Danaher (DHR), Exact Sciences (EXAS), LabCorp (LH), Quest Diagnostics (DGX),Thermo Fisher Scientific (TMO)

 

Research Begins: May 25, 2020

 

To see other ideas Blueshift Research is currently working on, please click here.

 

Blueshift Research’s sister company, Intro-act, has launched the Intro-act Scorecard, the C-suite’s standard, ongoing measure of corporate investor engagement.

 

The Scorecard optimizes the ROI on corporate access by measuring: Concentration, Directionality, Breadth, Impact, Depth, and Duration

 

See the sample Scorecard. Watch the Scorecard video.