The expansion history of GENOMICA: world referent in molecular diagnostics.

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Discover how the spanish biotech GENOMICA has become a world leader in the field of molecular diagnostics and genetic identification.

 

since its foundation in 1990 and capitalized to 100% by its parent company PharmaMar, which is currently the Spanish multinational global leader in the development and commercialization of antitumor drugs of marine origin, grows from its birth for a period of 16 years within the limits of the peninsula, where it becomes the leader in genetic-forensic identification and the first accredited organisation with ISO for this type of testing.

Thanks to these beginnings in the field of DNA technology and its accumulated experience in genetic-forensic techniques, the company moved a step further during this decade to enter the world of molecular diagnostics.

In the mid-1990s began marketing its first products focused on the diagnosis of infectious diseases. In the year 2003 started the development of CLART®, an innovative technology based on  low-density microarrays, which has made it possible to offer solutions in the diagnosis of infectious diseases fields and in the field of oncology. But all this we shall return later on.

 

Representation of DNA and its role in molecular diagnostics. Source Pixabay.

 

Let their history of international expansion. This begins in the year 2006, focusing initially on the European market through agreements with local distributors and the creation of commercial offices with their own staff.

A year later, in 2007, undertakes the jump to the American Continent, expanding its market to countries of Central and South America, what makes today GENOMICA be present in more than 40 countries around the world, struggling to stand on the podium of the global IVD market (Molecular Diagnostics In Vitro).

In January 2013 decides to take a decisive step that represented a turning point in its career of internationalization: the opening of its first subsidiary in Sweden (GENOMICS AB). Located in one of the most active areas of Europe in biomedical research and biotechnology, and benefit from this area of Free Trade , GENOMICS AB from a first moment focused on the Scandinavian market, and from their own sales force developed in this market managed to expand throughout Europe.

At the end of 2013, the multinational opens its first office of commercial representation in the People’s Republic of China, and in December 2017 was when it passes to inaugurate its subsidiaries in Brazil, based in Rio de Janeiro and commercial office in Sao Paulo, and China, based in the Biolake in the city of Wuhan, Hubei).

The latter is the basis Bioindustrial National of the city, where GENOMICA is benefiting from the advantages of Free Trade Area of this metropolis, which has more than 10 million inhabitants, and represents a core of economic importance in the Asian giant, also presenting good connections with the Chinese metropolis of Beijing and Shanghai, the future link with Hong Kong and the train direct to Europe.

 

Origins of its IVD technology.

Let us now return to the “molecular roots” in its history. 

 

Representation of Molecular Diagnostics In Vitro. Source Pixabay.

 

“Currently, GENOMICS invests more than a 25 per cent of its resources in R+D+i, whose fundamental lines are:
• Design of new products within the line CLART®,
Tumor Detection of mutations in liquid biopsy
• Improve our current molecular diagnostic platform.
• New diagnostic systems based on nanotechnology”. Rosario Cospedal, Managing Director of the Group GENOMICA.

 

In a unique way, this company is founded in the early 1990s with the aim of giving scientific answer to a social necessity: to implement a reliable method for the identification of people using the DNA test, which gives rise to the development of the forensic genetics for identification of suspects of crimes and their victims, providing evidence of kinship, the realization of international banks of genetic identity and studies of population genetics, among others.

In just three years, the company completed the design and assembly of the DNA labs of the Guardia Civil and the Spanish Scientific Police. It then completed the same work in various countries in Latin America and Africa, while at the same time offered services in analysis of kinship and genetic identification, which has led it to be one of the leading companies in the genetic-forensic identification at the global level.

It is in 2003 when GENOMICA initiates the development of CLART®, a new technology with its own patent based on a multiplex PCR. This allows multiple and simultaneous detection of different molecular targets in a single test, revealing in this way as a platform suitable for the development of personalized medicine.

The Display method is performed by  low-density microarrays, processing the samples in a very simple manner and the analysis of the results automatically through a software and a auto-reader (CAR® or CLINICAL ARRAY READER). In this way,  CLART® enables to identify the presence of papilloma virus, herpes, intestinal infections, respiratory conditions or sexually transmitted infections, as well as tumor markers and response to treatment in different types of cancer, such as lung cancer or melanoma, among others.

 

 

“Today we cannot correctly handle some tumors without their genetic study, molecular profile or information on differential characteristics. We hope that in the next 5-10 years its use will be essential in the treatment and monitoring of the 100% of the tumors”. Dr. Santiago Ramón y Cajal.

 

The simplicity of its design makes this technique in an easy-to-use tool, allowing the implementation of this technology in all kinds of laboratories for molecular diagnosis, selling more than 350,000 tests each year.

In addition, their use has proven to offer the possibility to make a quick, sensitive and specific diagnosis with high quality guarantees, which facilitates the clinician a decision on time.

 

Outline of the detection system. The probes immobilized on the surface of the microarray capture their respective complementary amplification products , marked with biotin. Then takes place the union of the biotin conjugate of streptavidin-peroxidase, followed by incubation with dianisidina, substrate of the peroxidase. This generates a precipitate in the area where it has taken place hybridization.

 

At the end of 2016 genomics published information about its new product that today is in development: NEDxA (Nano Electronic Diagnostic Array). This is their new automated equipment able to perform a test for HPV in less than 75 minutes.

Just insert the sample in a cartridge own, NEDxA genotipe all subtypes of high risk Human Papilloma Virus. The aim with this new instrument is to be able to perform a wide variety of molecular diagnostics with a single sample at a lower cost than “between a 30 and a 40 percent” to other similar products and through a compact platform, whose samples are taken in a rectangular container hardly bigger than a credit card.

 

Nedxa works with disposable cartridges specific to each test, is a closed system that requires no sample preparation, configuration or calibration process.

Designed, developed and manufactured to carry out complex analysis of laboratory in any field. NEDxA integrates all processes in a single device, providing a platform for molecular diagnosis quick, easy, specific and sensitive. NEDxA reduces the work-flow to a single step. An ideal instrument for non-specialist staff.

 

And is that the world of Molecular Diagnostics In Vitro brings us great capabilities for the development of personalized medicine, allowing us to deepen in the molecular basis of diseases and offering diagnostic systems that are affordable and easy to use and interpret.

 

Would you aventure to predict where it’s headed the upcoming trends in IVD? From Inspira Biotech we will be keep listening.

 

“The 21st century is known as the century of the medicine of precision”. With these words, Dr. Rafael López López explains how we have witnessed a paradigm shift in the treatment and management of complex diseases, some of which are chronicle, caused by the interaction of genetic or environmental factors. 

 

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