Question

Using the SARS-CoV-2 tests, explain the processes required for scaling up production of the newer diagnostic testing in a global pandemic and regulatory processes required for use of new diagnostic tests for COVID-19 within Australia, Europe and the United States of America. This section is to describe the some of the manufacturing challenges associated with meeting the rapid demand for tests during emergency or disaster management. Diagnostic tests require regulatory approval by FDA (US), TGA (Australia) and CE (European Union). How do companies ensure product can be continued to be manufactured and distributed to meet global need during a pandemic and what short cuts exist to certify products safe for use in humans during emergency situations such as a pandemic?

Answer 1

· WHO has identified the first two diagnostic tests for emergency use during the Covid-19 pandemic. The move should help improve access to quality-assured, reliable testing for the disease. It also means the tests will now be supplied by the United Nations and other procurement agencies that support the response to COVID-19.

· • Real-Time PCR Coronavirus (COVID-19) and cobas SARS-CoV-2 Qualitative Assay for use on cobas ® 6800/8800 Systems are both in vitro diagnostic tests.

· • "The emergency use listing of these items would allow countries to increase quality assured diagnostic testing," Enabling access to reliable testing is important for countries with the best available resources to tackle the pandemic.

· • The Emergency Use Listing (EUL) protocol was developed to speed up the availability of the treatments required in emergency situations in public health. It aims to help procurement agencies and countries manage the broad number of numerous devices on the market and, by reviewing them, provide assurance of the quality and performance of the goods.

· Today, as part of our continuing and vigorous dedication to combating the outbreak of coronavirus, the FDA revised its original guidance. Coronavirus diagnostic testing (COVID-19) with a view to achieving faster test ability in the United States. The groundbreaking policy set out in today's revised guidelines targeting laboratories and industrial producers, It will help resolve these critical public health issues by helping to increase the number and range of diagnostic tests, as well as the available research capacities in healthcare environments, and reference and industrial laboratories.

· • This action shows the FDA 's willingness to pivot and adjust in light of a public health emergency as the situation warrants. Considering the urgent need, we are taking steps to support diagnostic growth. We encourage state authorities and commercial developers to take all measures possible to ensure reliable tests are available. During a pandemic, incorrect diagnosis will hinder preventive efforts and postpone effective care of sick patients.

Our guidance contains more detailed information for the communities of laboratory and commercial manufacturers, but I would like to highlight three main elements of the update which we are releasing today.

· • First, we are putting in place a policy for states to take responsibility for tests produced and used by laboratories in their countries, similar to the action given last week by the FDA to the New York State Health Department. States may create a system where they assume responsibility for approving such tests and the laboratories will not engage with the FDA. The framework doesn't need to replicate that of New York as mentioned in the guidance. Laboratories designing tests in these states can interact directly with the relevant state authorities, rather than the FDA. These labs will not seek an Emergency Use Authorization (EUA) with FDA either.

· • Secondly, we are building on who contributes to the framework outlined in the Guidelines of 29 Feb. The policy was originally only applicable to laboratories that are accredited to conduct high-complexity research in compliance with the Clinical Laboratory Quality Amendments standards. Under the update published today, the Agency does not expect, under some cases, to object to commercial manufacturers selling and laboratories using new commercially produced tests until the FDA grants an EUA . The FDA is aware that several commercial manufacturers are designing coronavirus tests with a view to sending an EUA to the FDA. The FDA does not plan to object to the distribution and use of those tests during this public health emergency For specimen testing for a fair period of time after the manufacturer's validation of the test and while the manufacturer prepares its EUA order, where the manufacturer provides guidance for the use of the test and publishes details on the manufacturer's website about the test performance characteristics. As noted in the guidance, the FDA maintains that 15 business days is a fair time to schedule an EUA request for a test for which the manufacturer has already validated the performance characteristics.

· • Finally, the revised policy offers guidance to research developers who may wish to create serological tests for use during this coronavirus outbreak. When the body responds to a particular infection, serological tests evaluate the amount of antibodies or proteins found in the blood. Serology tests have been recognized to be less complex than molecular tests and are used primarily to identify antibodies that restrict their effectiveness for diagnosis; however, as stated in the updated guidance, the FDA does not plan to object to the distribution and use of serology tests to identify SARS-CoV-2 antibodies, Where the test has been validated, notice shall be issued to the FDA and warning statements shall be included with the samples, such as noting that the test has not been approved by the FDA and that the results of the antibody testing should not be used as the sole basis for diagnosing or excluding SARS-CoV-2 infection or informing the infection.

FDA Support of Diagnostics

· • As of the end of January, the FDA has been working with more than 100 software developers to provide models and guidance on the EUA process. More than 80 developers have sought our help in developing and validating the tests that they intend to carry through the EUA process. During this outbreak we have given multiple EUAs for diagnosis.

· • They update commonly asked questions for laboratories and research developers, and include information on alternate reagent sources, extraction kits, swabs and more.

· • They have also set up a toll-free line, 1-888-INFO-FDA, to assist laboratories with any concerns they may have about the EUA process, our policies or supply.

· • The FDA is primarily focusing on ensuring that samples are delivered and that research developers and laboratories have the materials needed to conduct the samples.

· • The FDA continues to work 24/7, and we are here to assist laboratories and research developers in delivering tests around the country in this time of urgent need.

Companies commit to realising a Great Reset of capitalism

· • The coronavirus pandemic has uncovered long-standing breakdowns in our economies and communities, causing a global crisis. As part of the wide-ranging response, this week the World Economic Forum launched its Great Reset initiative — a promise to jointly and urgently develop. The foundations for a fairer, more prosperous and more stable future for our economic and social system; The Great Reset is also the focus of a special twin summit to be held by the Forum in January 2021-both in-person in Davos and online around the world.

Life-saving logistics: how a cargo company is getting vaccines to people in need around the world

· • Vaccines save more than 2 million lives per year but vaccines will only save lives if they reach people in need. A global problem made more urgent by the COVID-19 pandemic is the secure transportation of critical materials from labs to stockpiles, and then to healthcare centers and communities.

· • The multinational logistics company UPS, a World Economic Forum Member, is working through its foundation to improve supply chains so that life-saving vaccines enter distressed populations worldwide. By investing $3 million in new funding over two years , the organization has ramped up work with Gavi, the Vaccine Alliance.

Private sector has critical role to play in ramping up Coronavirus testing

· • Deploying COVID-19 mass testing is necessary if economies are to reopen, Gingko Bioworks CEO Jason Kelly told this week's Virtual Meeting of the COVID Action Platform committee.

· • It was emphasized that companies would need to recognise pathogens rapidly and reliably, and ensure that staff, contractors and suppliers are separated to ensure continuity of operation. Introducing research regimes works in the company's interests but also helps the wider community. The virtual meeting has been advised that businesses must speed up testing as workers continue to return to work and that 5-10 million people in the U.S. will need to be screened in a single day, far higher than the current rate.