-- The SARS-CoV-2 Antigen Self Test Nasal enables individuals to quickly and 
      conveniently test themselves for COVID-19 at home using a simple nasal 
      swab 
 
   -- An early version of the test has already been available as a home-test in 
      a number of European markets under local special approval pathways since 
      February 2021 
 
   -- The test will be widely available to individuals through pharmacies and 
      other locations in accordance to local guidelines and testing strategies 
 
   -- The test works seamlessly with NAVIFY(R) Pass, Roche's digital solution 
      that allows individuals and healthcare providers to immediately store, 
      display, and share their COVID-19 test results and vaccine status through 
      a unique QR code 
 
   Basel, 08 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced 
it has received CE mark for its SARS-CoV-2 Antigen Self Test Nasal for 
at-home testing. The test will be available in countries accepting the 
CE mark through pharmacies and other locations, in packs of five tests. 
 
   An early version of the test has already been available as a home-test 
in a number of European markets under local special approval pathways 
since February 2021. With the CE Mark, the SARS-CoV-2 Antigen Self Test 
Nasal for rapid self testing of COVID-19 test has received official 
approval following the traditional registration pathway and can now also 
be used in markets that have not established regulatory exemption 
pathways. 
 
   By following simple instructions, individuals can perform the test at 
home using a nasal swab without special training or the supervision of a 
healthcare worker. The test provides results in as little as 15 minutes 
and can help people to conveniently check if they are likely to be 
infectious from the comfort of their home. In the case of children under 
18 years of age, the test must be performed by an adult or under close 
adult supervision. 
 
   As societies begin to reopen and in line with local health regulations, 
the convenient test allows individuals planning to attend an event or 
gathering to use the test as a tool to confirm that they are not likely 
to be carriers of a substantial amount of the virus thus helping them 
make informed decisions and reduce the risk of transmission to others. 
 
   Complementary to the SARS-CoV-2 Antigen Self Test Nasal, Roche is 
offering NAVIFY(R) Pass. This digital solution allows individuals and 
healthcare professionals to remotely store, display, and share their 
COVID-19 test results and vaccine status through a personalised QR code. 
Having easy digital access to test results and vaccination status could 
potentially be used by both individuals and companies to facilitate 
access to locations with COVID-19 entry protocols, such as restaurants 
or entertainment venues, as well as to validate safety to travel. 
 
   "As the world prepares to reopen, high-quality, home-based testing will 
play an important role in the battle against the pandemic," said Thomas 
Schinecker, CEO, Roche Diagnostics. "Regular self-testing at home can 
reduce pressure on healthcare systems. It can quickly identify people 
with the highest potential to be infectious so they can take immediate 
action to seek medical advice, manage their infection and protect 
others." 
 
   This test is part of a partnership with SD Biosensor Inc., with whom 
Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July 2020 
and two SARS-CoV-2 Rapid Antigen Tests for professional use in September 
2020 and February 2021. These tests will continue to play an important 
role in fighting this pandemic and remain available for healthcare 
professional testing. 
 
   In addition to diagnostic testing, preventive measures remain key to 
protecting yourself and others against SARS-CoV-2. It is recommended to 
continue wearing masks, socially distance and practice good hygiene, 
especially if you have symptoms or known contact with others who have 
tested positive for the virus. 
 
   Roche continues to expand its comprehensive COVID-19 portfolio to 
support healthcare systems in diagnosing SARS-CoV-2 infection. 
 
   About the SARS-CoV-2 Antigen Self Test Nasal for at-home patient 
self-testing 
 
   The SARS-CoV-2 Rapid Antigen Self Test Nasal is a rapid chromatographic 
immunoassay (lateral flow assay) for the detection of the nucleocapsid 
protein of SARS-CoV-2 in human nasal samples. Each test contains a 
unique QR code to enable individuals to share their test results and 
vaccine status using NAVIFY Pass, Roche's digital solution. For more 
information on NAVIFY Pass, visit www.navifypass.com 
 
   The clinical performance of the test was measured by head to head 
comparison with Roche's highly sensitive reverse transcriptase 
polymerase chain reaction (RT-PCR) test using nasopharyngeal swab 
samples as a comparator, the gold standard sampling and detection method 
for SARS-CoV-2 detection.(1,2) Combined study results showed that the 
relative sensitivity of the SARS-CoV-2 Antigen Self Test Nasal was 
91.1%.** The overall relative specificity was 99.6 %,(3) which 
represents the ability of the test to correctly identify patients 
without the virus. In one comparative independent self testing study 
where patients followed written and illustrated instructions to sample, 
test and read-out the results themselves, the majority of study 
participants considered the procedures easy to perform.(4) 
 
   About antigen testing 
 
   An antigen test detects proteins which are structural or functional 
components of a pathogen and are very specific to that pathogen.(5) In 
this case, the test would provide a qualitative "yes/no" answer on the 
presence of the antigen in the patient sample and can be offered as a 
rapid strip test that is performed at the point of care. If the target 
antigen (nucleocapsid protein) is present in sufficient concentrations 
in the sample, it will bind to specific antibodies and generate a 
visually detectable signal on the test strip, typically with results 
ready in 15 minutes. A rapid antigen test can reliably detect 
individuals with a high viral load allowing healthcare professionals to 
quickly identify those patients at the greatest risk of spreading the 
infection.(6) 
 
   About Roche's response to the COVID-19 pandemic 
 
   The COVID-19 pandemic continues to evolve globally with varying 
developments from country to country and we are partnering with 
healthcare providers, laboratories, authorities and organisations to 
help make sure that patients receive the tests, treatment and care they 
need. This new test is an additional step in Roche's fight against the 
COVID-19 pandemic, which has already included: 
 
 
   -- Launching COVID-19 diagnostic tests for active infection and the 
      detection of antibodies in patients who have been exposed to the virus, 
 
   -- Investigating treatments from our existing portfolio to better understand 
      their potential to treat patients with COVID-19, 
 
   -- Increasing manufacturing and supply chain capacity to meet product demand 
      across our portfolio within the wider context of COVID-19 treatment, and 
 
   -- Ensuring the supply of our existing medicines and diagnostics to patients 
      around the world under exceptional conditions. 
 
   Reliable, high-quality testing is essential to help healthcare systems 
overcome this pandemic. On 13 March 2020 we received FDA Emergency Use 
Authorization for a high-volume molecular test to detect SARS-CoV-2, the 
virus that causes COVID-19, which is also available in countries 
accepting the CE Mark. On 3 May 2020, Roche announced that its COVID-19 
antibody test, aimed at detecting the presence of antibodies in the 
blood, also received FDA Emergency Use Authorization and is available in 
markets accepting the CE mark. Also in June of last year we received an 
FDA EUA for the Elecsys(R) IL-6 test to assist in identifying severe 
inflammatory response in patients with confirmed COVID-19, as well as 
launching Roche v-TAC, which could help simplify the screening, 
diagnosis and monitoring of patients with respiratory compromise in the 
current COVID-19 pandemic. In July of 2020, we added a Rapid Antibody 
Test, with SD Biosensor as manufacturing partner, to the portfolio that 
allows the detection of antibodies against COVID-19 at the point of 
care. In addition, we also launched a Rapid Antigen Test in September 
and a lab-based Antigen Test in December. Roche is working closely with 
governments and health authorities around the world, and has 
significantly increased production to help ensure availability of tests 
globally. 
 
   Roche is actively involved in understanding the potential of the 
existing portfolio and is researching options for the future. Roche has 
an ongoing clinical trial program evaluating the role of 
Actemra(c)/RoActemra(c) (tocilizumab) in COVID-19 pneumonia. On 29 July 
2020 Roche announced that the COVACTA trial did not meet its primary 
endpoint of improved clinical status in patients with COVID-19 
associated pneumonia, or the key secondary endpoint of reduced patient 
mortality. The study was the first global, randomised, double-blind, 
placebo-controlled phase III trial investigating Actemra/RoActemra in 
this setting. Roche remains committed to continuing the 
Actemra/RoActemra clinical trial programme in COVID-19 to further 
explore Actemra/RoActemra in other treatment settings, including in 
combination with an antiviral. In addition to COVACTA, Roche has 
initiated several studies to further investigate Actemra/RoActemra as a 
potential treatment for patients with COVID-19 associated pneumonia, 
including two phase III clinical trials, REMDACTA and EMPACTA, as well 
as the phase II MARIPOSA trial. Roche has further initiated an internal 
early research programme focused on the development of medicines for 
COVID-19 and is engaged in multiple research collaborations. On 19 
August 2020, Roche announced a partnership with Regeneron to develop, 
manufacture and distribute REGN-COV2, Regeneron's investigational

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