Accessibility Statement Skip Navigation
  • Why PRWeb
  • How It Works
  • Who Uses It
  • Pricing
  • Login
  • GDPR
  • Create a Free Account
Return to PRWeb homepage
  • News
  • Resources
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All News Releases
      • Multimedia Gallery

      • All Multimedia
      • All Photos
      • All Videos
  • Business & Money
      • Auto & Transportation

      • Aerospace, Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads and Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking and Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers and Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls and Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil and Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation and Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking and Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers and Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines and Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food & Beverages
      • Furniture and Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks and Tourist Attractions
      • Gambling & Casinos
      • Hotels and Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Advocacy Group Opinion
      • Animal Welfare
      • Congressional & Presidential Campaigns
      • Corporate Social Responsibility
      • Domestic Policy
      • Economic News, Trends, Analysis
      • Education
      • Environmental
      • European Government
      • FDA Approval
      • Federal and State Legislation
      • Federal Executive Branch & Agency
      • Foreign Policy & International Affairs
      • Homeland Security
      • Labor & Union
      • Legal Issues
      • Natural Disasters
      • Not For Profit
      • Patent Law
      • Public Safety
      • Trade Policy
      • U.S. State Policy
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Hamburger menu
  • Cision PRWeb provides efficient communication tools to continuously engage with target audiences across multiple online channels
  • Create a Free Account
    • ALL CONTACT INFO
    • Contact Us


      11AM ET Sunday – 8PM ET Friday

  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR
  • News in Focus
    • Browse All News
    • Multimedia Gallery
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR
  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR
  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR

Bioprognos Obtains the CE Marking for its Algorithm to Support the Diagnostic of Lung Cancer
  • USA - English


News provided by

Bioprognos SL

Dec 16, 2016, 03:00 ET

Share this article

Share toX

Share this article

Share toX


This test has a much higher sensitivity and specificity ratios (90% and 98%, respectively), than any already existing test in the market, including the ones based on liquid biopsy only valid for the 4% of lung cancer patients with known genomic mutations.

Post this

Barcelona, Spain (PRWEB) December 16, 2016 -- BIOPROGNOS, the first Catalan biotechnology company to develop diagnostic support solutions for the detection of different types of cancer through a simple blood test, has been able to meet the European regulatory requirements necessary to start commercializing its test “MBDAA for Lung Neoplasia Dx” to support the diagnosis of lung cancer as well as confirmatory diagnostic ―used as a complement to Computed Tomography (CT), our test will lower the number of unnecessary tissue biopsies otherwise performed in cases of uncertainty―, in the European Economic Community.

This first test has a much higher efficacy ratios ―with a sensitivity and specificity of 90% and 98%, respectively―, than any already existing test in the market (including the ones based on liquid biopsy, only valid for patients with known genomic mutations ―DNA or RNA―, that affect only about 4% of lung cancer patients). Upcoming versions ―still in development―, show increased ratios according to preliminary results.

In order to achieve the CE Marking and the implementation of a quality management system (QMS), BIOPROGNOS has had the invaluable professional support of AZIERTA, a consulting firm specialized in regulatory affairs, pharmacovigilance, medical affairs, quality assurance in the field of manufacturing and distribution, as well as management in health and market access. Besides, both companies signed a framework contract that considers addicional lines of collaboration, such as the process of achieving the CE Marking for the algorithms to support the diagnosis of ovarian and prostate cancers ―two of the company’s products that are in their last stages of validation―, as well as the US and the China Food and Drug Administration (FDA and CFDA) compliance in order to market in the US and China too.

The test “MBDAA for Lung Neoplasia Dx” is the first algorithm developed by the company. It calculates the risk of lung cancer - and provides histological determination in the case of a positive test - combining the values of 6 tumour markers obtained with a simple blood test, with other clinical data from the patient.

BIOPROGNOS has developed this algorithm based on a study carried out at the Hospital Clínic de Barcelona (HCB) during the last 8 years, exploited by means of an exclusive licensing through a technology transfer contract signed with that institution and the Fundació Clínic per a la Recerca Biomèdica (FCRB).

Because it is a low-cost and non-invasive test, healthcare professionals will have access to a tool that will enable reducing the level of uncertainty as well as obtaining a more accurate diagnosis, with a greater sensitivity and specificity than diagnostic tests currently available. Enabling early diagnosis will decrease the health system’s costs, by lowering the number of consultations and tests, reserving those more expensive and invasive ones for the patients who really need them.

About Bioprognos

BIOPROGNOS (https://www.bioprognos.com/) is a biotech company located in Barcelona, created in January 2016 as a spin-off of the HCB. BIOPROGNOS is dedicated to the development of diagnostic solutions for the detection of different types of cancer through a simple blood test.

As per our production roadmap, the tests for lung, ovarian and prostate cancer, will be followed by others for head and neck, colorectal, kidney and breast cancers, developed in collaboration with different national and international hospitals and research centres.
 
About Azierta

AZIERTA (http://www.azierta.eu) is a consultancy that offers, since 2011, services specialized in Science and Health through a multidisciplinary team of professionals.

From its offices in Madrid, Barcelona and Bogota (Colombia), it provides comprehensive scientific support to more than 200 clients in the field of Medicines and Health Products, as well as Cosmetics, Hygiene Products and Food Supplements, supporting companies from the R & D up to the market, as well as in post-marketing activities.

Azierta is results-oriented, always taking into account the clients’ needs, and guided in its day to day by the following values: integrity, excellence, commitment, trust and innovation.

Anna M Betoret Turon, Bioprognos SL, http://www.bioprognos.com, +34 938564886, [email protected]

Modal title

Bioprognos' MBDAA for Lung Neoplasia Dx v.2.0 Interface
Bioprognos' MBDAA for Lung Neoplasia Dx v.2.0 Interface
Bioprognos' MBDAA for Lung Neoplasia Dx v.2.0 Interface

Contact PRWeb

  • 11AM ET Sunday – 8PM ET Friday
  • Contact Us

About PRWeb

  • About PRWeb
  • Partners
  • Partnership Programs
  • Editorial Guidelines
  • Resources

Why PRWeb

  • Why PRWeb
  • How It Works
  • Who Uses It
  • Pricing

Accounts

  • Create a Free Account
  • Log in
  • Contact Us

Do not sell or share my personal information:

  • Submit via [email protected] 
  • Call Privacy toll-free: 877-297-8921

Contact Cision

Products

About

My Services
  • All News Releases
  • Online Member Center
  • ProfNet
Cision Distribution Helpline
888-776-0942
  • Legal
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 Cision US Inc.