* The test uses highly sensitive PCR technology, requiring only a single

    nasal-swab sample to provide rapid, accurate qualitative detection and
    differentiation among four of the most prevalent respiratory viruses for
    which differential diagnosis can drive appropriate treatment.
  * Enables healthcare professionals to make confident clinical decisions and
    promptly determine appropriate treatment, with definitive results reported
    in just 20 minutes.
  * Expands Roche's extensive molecular point of care testing portfolio,
    offering greater flexibility to meet testing needs amid evolving regional
    prevalence of respiratory infections.

Basel, 10 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that
the U.S. Food and Drug Administration (FDA) has granted Emergency Use
Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic
acid test, an automated multiplex real-time polymerase chain reaction (RT-PCR)
assay on the cobas® liat system. Producing results in just 20 minutes on a
compact analyser suitable for most healthcare settings, the test uses either a
single nasopharyngeal or anterior nasal-swab sample to confirm or rule out
infection with SARS-CoV-2, influenza A virus, influenza B virus and respiratory
syncytial virus (RSV).
"Diagnostics play a critical role in the fight against respiratory illness,"
said Matt Sause, CEO of Roche Diagnostics. "We are proud to provide this
innovative test to address the significant burden placed on healthcare systems.
Now, healthcare professionals will be able to detect and differentiate these
respiratory viruses within a single patient visit, enabling improved public
health outcomes."
Introducing rapid multiplex PCR diagnostic tests into near-patient care
environments such as emergency departments, urgent care facilities, and
physician office labs has the potential to provide swift and precise results,
expediting clinical decision-making processes. This approach can help reduce
unnecessary antibiotic usage, facilitate targeted treatment strategies, and
ultimately enhance patient outcomes and healthcare system efficiency.(1-6 )
According to the U.S. Centers for Disease Control and Prevention (CDC),
respiratory diseases in the United States reached high levels during the most
recent autumn and winter seasons, with SARS-CoV-2 causing the most emergency
department visits.(7) Hospitalisations due to respiratory illness place a strain
on hospitals and can result in delayed diagnosis and treatment for patients.(8
)In the 2023-2024 respiratory season, infants, children, and adults ages 65 and
older were observed to have the highest rates of emergency department visits and
hospitalisations caused by SARS-CoV-2, influenza, and RSV.(9,10) Nationwide, the
percentage of recent total deaths due to these respiratory viruses was highest
among patients 65 and older.(11)
The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test authorised for
emergency use further expands and complements Roche's broad portfolio of single
and multiplex tests intended to help diagnose and address the needs of patients
presenting with symptoms of respiratory illness, including the following assays:
cobas® SARS-CoV-2, cobas® Strep A, cobas® SARS-CoV-2 & Influenza A/B, and cobas®
Influenza A/B & RSV for use on the cobas liat system. In 2025, Roche intends to
seek FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments of
1988 (CLIA) waiver in the United States for the new test, with plans for
commercial launch in other markets worldwide following CE-IVDR approval.
About the cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test(12)
The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is an automated
rapid multiplex real-time reverse transcription polymerase chain reaction (RT-
PCR) test intended for the simultaneous qualitative detection and
differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-
2), influenza A virus, influenza B virus and respiratory syncytial virus (RSV)
RNA in anterior nasal (nasal) swab and nasopharyngeal swab specimens collected
from individuals with signs and symptoms of respiratory tract infection
consistent with COVID-19 by their healthcare provider. Clinical signs and
symptoms of respiratory viral infection due to SARS-CoV-2, influenza and RSV can
be similar.
Testing is limited to laboratories certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements
to perform high, moderate or waived complexity tests. The cobas liat SARS-CoV-
2, Influenza A/B & RSV nucleic acid test is authorised for use at the Point of
Care (POC), i.e., in patient care settings operating under a CLIA Certificate of
Waiver, Certificate of Compliance, or Certificate of Accreditation.
Results are for the simultaneous detection and differentiation of SARS-CoV-2,
influenza A, influenza B and RSV viral RNA in clinical specimens and are not
intended to detect influenza C virus. SARS-CoV-2, influenza A, influenza B and
RSV RNA are generally detectable in nasal swab and nasopharyngeal swab specimens
during the acute phase of infection. Positive results are indicative of the
presence of SARS-CoV-2, influenza A, influenza B and/or RSV RNA; clinical
correlation with patient history and other diagnostic information is necessary
to determine patient infection status. Positive results do not rule out
bacterial infection or co-infection with other pathogens not detected by the
test. The agent detected may not be the definitive cause of disease.
Negative results do not preclude SARS-CoV-2, influenza A, influenza B and/or RSV
infection and should not be used as the sole basis for patient management
decisions. Negative results must be combined with clinical observations, patient
history, and/or epidemiological information.
The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is intended for
use by trained operators specifically instructed in the use of the cobas liat
system and the cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. The
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is only for use
under the Food and Drug Administration's Emergency Use Authorization.
About the cobas liat system
The cobas liat system combines the cobas liat analyser - an automated nucleic
acid test instrument - with cobas liat assay tubes to fully automate the testing
process, simplify workflows, and enable healthcare professionals to perform
molecular testing in a variety of near-patient settings with speed, reliability,
and minimal training. The system performs reagent preparation, target
enrichment, inhibitor removal, nucleic acid amplification, polymerase chain
reaction (PCR) amplification, real-time detection, and result interpretation to
automate the detection and quantification of nucleic acid targets in a
biological sample in a single closed tube. Definitive results are generated in
20 minutes or less to aid in patient care decisions. The cobas liat SARS-CoV-2,
Influenza A/B & RSV Assay complements existing tests for SARS-CoV-2 & Influenza
A/B, Influenza A/B & RSV, Strep A, and Cdiff. Assays for other infectious
diseases are currently in development. More information is available at
diagnostics.roche.com (http://www.diagnostics.roche.com). The cobas liat system
is commercially available in select markets.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial
manufacturers of branded medicines, Roche has grown into the world's largest
biotechnology company and the global leader in in-vitro diagnostics. The company
pursues scientific excellence to discover and develop medicines and diagnostics
for improving and saving the lives of people around the world. We are a pioneer
in personalised healthcare and want to further transform how healthcare is
delivered to have an even greater impact. To provide the best care for each
person we partner with many stakeholders and combine our strengths in
Diagnostics and Pharma with data insights from the clinical practice.
In recognising our endeavour to pursue a long-term perspective in all we do,
Roche has been named one of the most sustainable companies in the
pharmaceuticals industry by the Dow Jones Sustainability Indices for the
fifteenth consecutive year. This distinction also reflects our efforts to
improve access to healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the Roche Group.
Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit roche.com (http://www.roche.com).
All trademarks used or mentioned in this release are protected by law.
References
(1) May L, Robbins EM, Canchola JA, Chugh K, Tran NK. A study to assess the
impact of the cobas point-of-care RT-PCR assay (SARS-CoV-2 and Influenza A/B) on
patient clinical management in the emergency department of the University of
California at Davis Medical Center. J Clin Virol. 2023;68:105597.
doi:10.1016/j.jcv.2023.105597.
(2) Hansen GT, Moore J, Herding E, et al. Clinical decision making in the
emergency department setting using rapid PCR: Results of the CLADE study group.
J Clin Virol. 2018;102:42-49. doi:10.1016/j.jcv.2018.02.013.
(3) Berry L, Lansbury L, Gale L, Carroll AM, Lim WS. Point of care testing of
Influenza A/B and RSV in an adult respiratory assessment unit is associated with
improvement in isolation practices and reduction in hospital length of stay. J
Med Microbiol. 2020;69(5):697-704. doi:10.1099/jmm.0.001187.
(4) Garvey MI, Wilkinson MAC, Bradley CW, Biggs M, et al. Impact of a PCR point
of care test for influenza A/B on an acute medical unit in a large UK teaching
hospital: results of an observational, pre and post intervention study.
Antimicrob Resist Infect Control. 2019;16;8:120. doi:10.1186/s13756-019-0575-6.
(5) Patel P, Laurich VM, Smith S, Sturm J. Point-of-Care Influenza Testing in
the Pediatric Emergency Department. Pediatr Emerg Care. 2020;36(11):515-518.
doi:10.1097/PEC.0000000000002250.
(6) Youngs J, Marshall B, Farragher M, et al. Implementation of influenza point-
of-care testing and patient cohorting during a high-incidence season: a
retrospective analysis of impact on infection prevention and control and
clinical outcomes. J Hosp Infect. 2019;101(3):276-284.
doi:10.1016/j.jhin.2018.11.010.
(7) Centers for Disease Control and Prevention. Public Health and Surveillance
Data. RESP-LENS Interactive Dashboard. Accessed May 28, 2024.
https://www.cdc.gov/resp-
lens/dashboard/?CDC_AAref_Val=https://www.cdc.gov/surveillance/resp-
lens/dashboard.html
(8) Centers for Disease Control and Prevention. Respiratory Illnesses. CDC
Respiratory Virus Updates. Published January 12, 2024. Accessed January
24, 2024. https://www.cdc.gov/respiratory-viruses/whats-new/track-hospital-
capacity.html
(9) Centers for Disease Control and Prevention. Respiratory Illnesses. Groups
Most Impacted-Emergency Department Visits. Published February 9, 2024. Accessed
February 13, 2024. https://www.cdc.gov/respiratory-viruses/data-
research/dashboard/most-impacted-emergency-department-visits.html
(10) Centers for Disease Control and Prevention. Respiratory Illnesses. Groups
Most Impacted-Hospitalizations. Published February 9, 2024. Accessed February
13, 2024. https://www.cdc.gov/respiratory-viruses/data-research/dashboard/most-
impacted-hospitalizations.html
(11) Centers for Disease Control and Prevention. Respiratory Illnesses. Groups
Most Impacted-Deaths. Published May 24, 2024. Accessed May 28, 2024.
https://www.cdc.gov/respiratory-viruses/data-research/dashboard/most-impacted-
hospitalizations.html
(12) This product has not been FDA cleared or approved but has been authorized
for emergency use by FDA under an EUA for use by authorized laboratories
certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA),
42 U.S.C. §263a, to perform high, moderate or waived complexity tests. This
product is authorized for use at the Point of Care (POC), i.e., in patient care
settings operating under a CLIA Certificate of Waiver, Certificate of
Compliance, or Certificate of Accreditation. This product has been authorized
only for the detection and differentiation of nucleic acid from SARS-CoV-2,
influenza A, influenza B, and RSV, not for any other viruses or pathogens. The
emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §
360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked
sooner.
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