Bioprognos Obtains the CE Marking for Its Algorithm to Support the Diagnostic

of Lung Cancer
Bioprognos obtains the CE Declaration of Conformity for its algorithm to support the diagnostic of
lung cancer after complying with the requirements of the European directive on medical devices and
implementing a quality management system according to the standard UNE-EN ISO 13485:2016.
Barcelona, Spain, December 19, 2016 --(PR.com)-- 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 additional 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 Clnic de Barcelona
(HCB), one of top reference research centers worldwide, during the last 8 years, exploited by means of an
exclusive licensing through a technology transfer contract signed with that institution and the Fundaci
Clnic per a la Recerca Biomdica (FCRB).
Because it is a low-cost and non-invasive test, healthcare professionals will have access to a tool that will
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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 (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 (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.

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Contact Information:
Bioprognos SL
Anna M Betoret Turon
0034938564886
Contact via Email
https://www.bioprognos.com

Online Version of Press Release:

You can read the online version of this press release at: http://www.pr.com/press-release/698881

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