COVID-19 Diagnostics Update: News from Roche, Sanofi, FDA

Roche develops antibody test for COVID-19, and Sanofi partners for smartphone-based self-test for COVID-19. FDA provides overall COVID testing update.

Roche Develops Serology Test to Detect COVID-19 Antibodies
Roche has initiated the development and launch of its Elecsys Anti-SARS-CoV-2 serology test, an in vitro  test, using human serum and plasma drawn from a blood sample to detect antibodies and determine the body’s immune reaction in people who have been exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes the COVID-19 disease.

The Elecsys Anti-SARS-CoV-2 immunoassay is an in vitro test, using human serum and plasma drawn from a blood sample, to detect antibodies and determine the body’s immune reaction to SARS-CoV-2. The test may be used in epidemiological research to help better understand the spread of the disease and may also be used together with molecular tests to aid in the diagnosis of suspected COVID-19 patients. Hospitals and reference laboratories can run the test on Roche’s cobas e analyzers.

Roche aims to have this test available by early May (May 2020), in countries accepting the CE-IVD mark, which is granted through completion of technical validation and self-declaration under the European Directive for In Vitro Diagnostic Medical Devices. Roche is also working with the US Food and Drug Administration for an emergency use authorization, which allows FDA to evaluate and approve the use of medical countermeasures needed during public health emergencies

Roche is planning on an accelerated ramp-up of monthly production to high double-digit million tests by June (June 2020) and says it will further scale up production as soon as possible.

Source: Roche

Sanofi, Luminostics Form Pact To Develop COVID Smartphone Self-Test
Sanofi and Luminostics, a San Jose, California-based healthcare start-up company, have formed a collaboration for a smartphone-based self-testing system for COVID-19 to eliminate the need for healthcare professional administration or laboratory tests.

Under the agreement, Luminostics will use its proprietary technology for consumer-diagnostics for COVID-19 testing while Sanofi will use its clinical research testing and capabilities. The companies’ goal is to provide a consumer-based test that can detect the COVID-19 virus with high sensitivity and specificity from respiratory samples. The total time from specimen collection to results is expected in the range of 30 minutes or less. It is based on Luminostics’ technology that uses consumer smartphone’s optics, controlled by an iOS/Android app that is paired with an adapter in combination with nanochemistry and signal-processing artificial intelligence.

The diagnostic platform is composed of an iOS/Android app to instruct a user on how to run the test, capture and process data to display test results, and then to connect users with a telehealth service based on the results. It uses a reusable adapter compatible with most types of smartphones and has consumables for specimen collection, preparation, and processing.

Both companies anticipate to start development activities in the coming weeks (as reported on April 16, 2020). Sanofi and Luminostics expect to execute a final collaboration agreement including a plan for accelerated ramp up of necessary manufacturing capabilities. If development activities can be successfully conducted, the aim is to have an over-the-counter self-testing solution ready before the end of 2020, subject to obtaining required regulatory clearances.

Source: Sanofi

FDA Provides Update on COVID-19 Testing
The US Food and Drug Administration provided an update of testing for the novel coronavirus (COVID-19) as of April 22, 2020.

The FDA reported that during the COVID-19 pandemic, the FDA has worked with more than 360 test developers who have said they will be submitting emergency use authorizations (EUA) requests to the FDA for tests that detect the virus. To date (as of April 22, 2020), the FDA has issued 43 individual EUAs for test kit manufacturers and laboratories. In addition, 17 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests.

Additionally, the FDA has been notified that more than 215 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.

Also, the FDA reported on April 21, 2020, that it had authorized the first diagnostic test with an at-home sample collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for LabCorp’s COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit. The reissued EUA permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. After patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing. LabCorp intends to make the Pixel by LabCorp COVID-19 Test home collection kits available to consumers in most states, with a doctor’s order, in the coming weeks (as reported on April 21, 2020).

Source: US Food and Drug Administration (overall update) and FDA (Lab Corp self-test)

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