Bioprognos Obtains the CE Marking for its Algorithm to Support the Diagnostic of Lung Cancer

Share Article

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.

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.

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.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Anna M Betoret Turon
@bioprognos
since: 12/2015
Follow >
bioprognos
since: 12/2015
Like >
Bioprognos

Visit website