X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development Research & Development

Roche receives FDA CLIA waiver for flu A/B test for use on its cobas Liat PCR System

Yuvraj_pawp by Yuvraj_pawp
5th October 2015
in Research & Development

First CLIA-waived, real-time PCR tests for flu and Strep A now available for physician offices and pharmacies

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobasĀ® Influenza A/B test for use on the cobasĀ® Liat System. It is the first CLIA-waived, real-time polymerase chain reaction (PCR) test to detect influenza A and B in ~20 minutes. Coupled with the CLIA waived cobas Strep A test, the cobas Influenza A/B test can now be used by healthcare providers in non-traditional testing sites, including physician offices, emergency rooms, health department clinics, pharmacy clinics and other healthcare facilities.

ā€œToday’s CLIA waiver for the cobas Influenza A/B test allows real-time PCR technology, the gold standard in molecular testing, to be utilized at the point of care to accurately and quickly detect and differentiate influenza A and B,ā€ said Roland Diggelmann, COO, Roche Diagnostics. ā€œEffective management of influenza relies on accurate detection within 48 hours of onset, which can be challenging with current turnaround times for lab-based test results. The cobas Influenza A/B test provides lab-quality PCR results in ~20 minutes, enabling health care providers in all settings to give prompt and confident diagnosis and treatment to patients.ā€

An estimated three to five million individuals develop influenza each year worldwide, and 250,000 to 500,000 die from the virus.1 Patients at highest risk include children, the elderly and pregnant women.

The CLIA waived cobas Influenza A/B test for the cobas Liat PCR System offers an effective, new diagnostic tool to clinicians for the upcoming flu season and provides faster diagnosis and treatment for patients in primary and urgent care settings.

The cobas Influenza A/B test is the second assay on the cobas Liat System to receive CLIA waiver, following the cobas Strep A test, which received CLIA waiver in May 2015. The cobas Liat Analyzer, cobas Influenza A/B test and cobas Strep A test are CE Marked, FDA cleared and CLIA waived.

About the cobas Influenza A/B test

The cobas Influenza A/B test uses real-time PCR technology to detect and differentiate influenza A virus and influenza B virus RNA in ~20 minutes. It targets highly conserved regions of the influenza A and B genomes to provide broad strain coverage of over 30 commonly found strains of influenza A and B.

About the cobas Liat System

Utilizing polymerase chain reaction (PCR) technology, the cobas Liat System fully automates the testing process, simplifies workflow and enables healthcare professionals to perform molecular testing in a variety of settings with speed, reliability and minimal training. Definitive results are generated in 20 minutes or less to aid a treatment decision. In addition to the existing tests for flu A/B and Strep A, assays for other infectious diseases are in development.

About real-time PCR

Real-time PCR is widely recognized as the gold standard for molecular testing. It is highly accurate and offers a low limit of detection (LOD) to detect viruses in patients with low viral load, such as some adults with influenza infection. PCR is also extremely versatile, offering capabilities with high multiplex testing (e.g. influenza A, influenza B and RSV in the same test), quantification (viral load count), and detection. Additionally, compared to physician clinical management, rapid antigen testing and other point-of-care testing methods, real-time PCR has demonstrated improved detection of influenza.

More information is available at go.roche.com/cobasliat or www.cobasliat.com.

The cobasĀ® Liat System is not commercially available in all markets.

About influenza A and B (flu)

Influenza is an acute respiratory illness caused by infection with the influenza virus. Influenza viruses consist of three types: influenza A, influenza B and influenza C. In the U.S., influenza A/H1N1, A/H3N2 and influenza B are the predominant seasonal viruses. Influenza A and B viruses are among the leading causes of respiratory infections, estimated to affect 5-10% of adults and 20-30% of children every year worldwide. Influenza is primarily spread by breathing in infected droplets formed when a person with the flu sneezes, coughs, or talks. Symptoms include fever, cough, headache, fatigue, muscle pain, sore throat, and runny nose. Elderly people, young children, and people with weakened immune systems or chronic medical conditions can be at high risk for serious disease. Each year, approximately 3 to 5 million people develop severe illness and 250,000 to 500,000 people die from the flu.

Previous Post

The 9th Asian & Oceanic epilepsy Congress

Next Post

For the 7th year running, Roche ranked most sustainable healthcare company in the Dow Jones Sustainability Indices

Related Posts

Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows
Manufacturing

Commercial Success In New Biopharmaceutical Innovation Era

21st May 2022
Manufacturing

Proteros and AstraZeneca Boost Collaboration Agreement

18th May 2022
SEQENS Makes Multi-Million-Dollar Investment in U.S. R&D Laboratory
Middle East and South Asia

SEQENS Makes Multi-Million-Dollar Investment in U.S. R&D Laboratory

22nd March 2022
Exscientia and Sanofi establish strategic research collaboration to develop AI-driven pipeline of precision-engineered medicines
Press Statements

Exscientia and Sanofi establish strategic research collaboration to develop AI-driven pipeline of precision-engineered medicines

17th January 2022
COVID-19 Impact On Changing Pharma Research And Development
News

COVID-19 Impact On Changing Pharma Research And Development

12th January 2022
immuno-oncology therapies
Drug Development

AbbVie, University of Chicago Extend Research Collaboration to Support Preclinical Oncology Research Through 2025

19th November 2021
Next Post

For the 7th year running, Roche ranked most sustainable healthcare company in the Dow Jones Sustainability Indices

Latest News

Global Biopharmaceutical Bioseparation Market Eyeing $20bn
Manufacturing

Global Biopharmaceutical Bioseparation Market Eyeing $20bn

4th July 2022
FDA Advises Adding Omicron BA.4, 5 To COVID-19 Boosters
Manufacturing

FDA Advises Adding Omicron BA.4, 5 To COVID-19 Boosters

4th July 2022
COVID-19 Omicron-Specific Vaccines Could Be Used As Boosters
Manufacturing

COVID-19 Omicron-Specific Vaccines Could Be Used As Boosters

4th July 2022
Fasenra shows consistent safety and sustained efficacy in long-term Phase III BORA trial in severe eosinophilic asthma
Manufacturing

AstraZeneca Cites Early Lung Cancer Immunotherapy Success

4th July 2022
FDA Experts Recommend Changing COVID Jab Formulation In Fall
Manufacturing

FDA Experts Recommend Changing COVID Jab Formulation In Fall

30th June 2022
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

Ā© 2017 Copyright Ā© Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

Ā© 2017 Copyright Ā© Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In