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US$21-million investment in molecular diagnostic platforms

FIND chooses four firms with promising new platforms for decentralized diagnosis of COVID-19 and other illnesses.

FIND is investing US$21-million to speed the development, manufacturing and launch of affordable, multi-pathogen, molecular diagnostic platforms.

These platforms are specifically aimed at decentralized settings in low- and middle-income countries (LMICs), and will detect different respiratory pathogens, including COVID-19.  

FIND launched the request for proposals in August 2021, in the context of the Access to COVID-19 Tools (ACT) Accelerator diagnostics pillar, which it co-leads. 

The submission deadline was September and the successful firms announced on December 2021.

The four firms are:

The German Federal Ministry of Education and Research (BMBF) is funding the investments through KfW and other donors. 

Read the full report here

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Call to boost access to cheaper rapid diagnostic tests

Key takeaway: RDT agreements boost local manufacturing to supply millions of low-cost, high-quality tests for lower-income nations.

In July 2020 FIND and Unitaid launched a call via the Access to COVID-19 Tools Accelerator Diagnostics Pillar for expressions of interest (EOI) to speed up availability and scale up manufacturing of rapid diagnostic tests (RDTs) for COVID-19.

The EOI was geared towards increasing supply of regulatory approved, fit-for-purpose SARS-CoV-2 Ag RDTs that met WHO criteria of quality, cost and accessibility. This was particularly needed in low- and middle-income countries (LMICs).

Innovators, developers and manufacturers of RDTs and in vitro diagnostics, and LMIC-based diagnostic stakeholders, were invited to submit proposals.

Interventions included:

  • Accelerating late-stage product development and optimization
  • Facilitating technology transfer activities
  • Conducting performance evaluation studies to support regulatory submissions
  • Increasing production capacity
  • Addressing supply chain challenges
  • Strengthening local capacity for development and deployment of new tests within national testing strategies. 

Driving down prices and supporting the use of less invasive specimens to enable faster LMIC uptake were also critical. 

Over 100 applications were received, with 34 selected for review by a panel of external experts. 

A first collaboration, with Premier Medical Corporation in India, was announced in January 2021. By July that year, additional technology transfer agreements were signed with stakeholders in Africa and Latin America.

These included an agreement with DCN Dx to transfer know-how to WAMA Diagnóstica (Brazil), and with Bionote and Mologic to transfer know-how to DIATROPIX of the Institut Pasteur de Dakar (Senegal). 

There is a separate partnership between Viatris (South Africa) and Guangzhou Wondfo Biotech (China).

These agreements will lead to a dramatic increase in local manufacturing, ultimately making more than 250 million low-cost (US$2–2.50) tests available for LMICs. 

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SARS-CoV-2 diagnostic use cases

Nine examples of when to use COVID-19 investigative procedures

FIND has supported partner Halteres Associates in developing diagnostic use cases for SARS-CoV-2 tests, which highlight the comparison, contrast and implications for each. 

This report outlines nine diagnostic use cases where further assays or investigative procedures are warranted. 

It provides a description of each use case, other possible technologies required, more information on the sample and comments.

Use cases for SARS-CoV-2 assays

  1. Triage of symptomatic individuals in an epidemic setting
  2. Triage of symptomatic individuals in endemic settings
  3. Triage of at-risk pre-symptomatic and symptomatic individuals in endemic settings
  4. Confirmatory testing
  5. Diagnosis of symptomatic individuals in endemic or epidemic settings
  6. Differential diagnosis in endemic or epidemic settings
  7. Previous SARS-CoV-2 exposure
  8. Surveillance in sites of previous or potential outbreaks
  9. Environmental monitoring.

Learning curve
Before developing systems, however, it is essential that test developers understand the details of use cases for SARS-CoV-2 testing. 

This includes who will be tested, by whom, the site of testing, using which samples, under what conditions, and what the minimum acceptable clinical performance requirements are likely to be. 

The most important component is intended use: what clinical decision the test will enable, and in what patient population. 

For more information, contact us or Halteres Associates.

Read the full text here

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How genomics can help track new SARS-CoV-2 variants

Sequencing data key for monitoring virus and understanding impact of therapeutics.

This report on SARS-CoV-2 variants, developed and published for FIND (11 March, 2021) by PHG Foundation, explains how genomics helps to monitor the evolution of coronavirus “variants of concern”, or VOCs.

It outlines how genomic surveillance and sequencing have supported identification of new variants as well as the impact these variants have had on diagnostic tests and public health measures. 

This process has also significantly advanced vaccine design and development. 

Ongoing surveillance is required not only for known VOCs, but also for new “variants of interest” (VOIs).

Thinking ahead
Data produced has enabled further understanding of the variants, helping to inform future surveillance and the impact mutations may have on vaccines, diagnostics and therapeutics. 

Various countries have invested in sequencing infrastructure and resources to help combat the virus, and have put public health measures in place in response. 

Continued investment in sequencing capabilities and data sharing, as well as a variety of skills and expertise from multiple backgrounds, is needed to make genomic surveillance successful. 

In addition, it is important to limit the spread of the virus to prevent the emergence of additional variants which may be even more transmissible. 

Sequencing data continues to be key for monitoring the virus and understanding the impact of therapeutics.

An appendix on resources actively monitoring VOCs is included.

Read the full report here

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Global genomic surveillance strategy for pathogens with pandemic and epidemic potential, 2022–2032

Looking at the decade 2022-2032, WHO presents a global genomic surveillance strategy for pathogens with pandemic and epidemic potential.

The goal is to strengthen and scale surveillance of these pathogens to enable quality, timely and appropriate public health actions across local to global surveillance systems.

WHO’s strategy outlines five objectives with accompanying actions that need implementation plans.

It also highlights considerations to build global genomic surveillance over the next 10 years, as well as monitoring and evaluation mechanisms.

The report includes two annexes:

  • Strategy development and stakeholder engagement
  • Key WHO assets for the strategy.

Read report here

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Genomic sequencing of SARS-CoV-2: a guide to implementation for maximum impact on public health, 8 January 2021

WHO released its publication, Genomic sequencing of SARS-CoV-2: a guide to implementation for maximum impact on public health, on 8 January 2021.

As the genomes of SARS-CoV-2 are able to be sequenced almost within real time, this enables increased speed to inform public health responses.

This has led to more laboratories investing in viral genome sequencing. Before starting such a programme, however, the intended goals of sequencing must be understood and a strategy for analysis in place, as well as a plan for how findings will be used.

Decisions about sequencing goals should be made in a multidisciplinary framework that includes representatives of all stakeholders. Funding sources must also be identified, and ethical aspects evaluated.

To maximize public health impact, usable and timely results need to be produced and communicated.

This document, available in English and Portuguese, provides this type of guidance for laboratories on maximizing the impact of SARS-CoV-2 sequencing activities now and in the future.

Read the guide here