ALA Diagnostics Raises €1.4 Million in European Grants

ALA Diagnostics is preparing to introduce its technology in the United States. The Spanish biotechnology company specializing in the development of in vitro diagnostic kits for pathologies with high prevalence or unmet medical needs is preparing to market its diagnostic test in the United States once it receives authorization from the Food and Drug Administration (FDA). At the same time, the company has just received €1.4 million in public funding, according to José Ramón Montero, CEO of ALA Diagnostics.

The biotech company has received a non-refundable grant from the European Commission for its early diagnosis system for Multiple Sclerosis (MS) for research and development (R&D) activities. In addition, the company will receive €1 million in equity in a future round, which will help with commercialization activities.

The grant will be used to complete the clinical trials necessary to commercialize ALA Diagnostics’ diagnostic test in the United States and also in Europe. The test, based on the first specific biomarker for the diagnosis of multiple sclerosis in blood (serum), will address an unmet medical need by generating a diagnostic product that will contribute to improving the quality of life of MS patients.

The strategy proposed for its development pursues two main objectives: the design of the industrial prototype in the form of a marketable kit for the diagnosis of MS in serum, and the integration of this test in a diagnostic algorithm that will make it possible to achieve a sensitivity value of over 95% in the diagnosis of MS, according to Montero.

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ALA Diagnostics closed in 2021 its first round of financing for the development of the ALA Diagnostics Em Kit

In addition to the research and development activities necessary to complete the development of the diagnostic kit and international clinical trials, the grants will allow ALA Diagnostics to strengthen key positions in the company and provide it with the production capabilities necessary to tackle the commercialization of the product in the United States.

ALA Diagnostics was founded in 2019 as a result of the identification of an opportunity for the development of a diagnostic kit in blood for Multiple Sclerosis, applicable to the early diagnosis of the disease, based on a recombinant protein whose activity as a diagnostic biomarker has already been validated in two clinical studies.

In 2021, the company closed its first round of financing for the development of the ALA Diagnostics Em Kit, the first test for the early diagnosis of Multiple Sclerosis in blood. The test is based on a recombinant protein whose activity as a diagnostic biomarker has already been validated in 598 samples.

The diagnostic kit that ALA Diagnostics plans to put on the market combines a specific biomarker for the detection of MS in blood, a design that allows its easy integration into the clinical routine, and a diagnostic algorithm that provides greater diagnostic accuracy.

José Ramón Montero, in addition to being the company’s CEO, has fourteen years of experience in the biotechnology sector, performing functions related to the management of research, development and innovation (R&D&I) projects, project feasibility analysis, preparation of business plans, business strategy and advising biotech start-ups.

He is joined on the management team by Óscar Fernández, a clinical neurologist with more than 40 years of experience. Fernández has been principal investigator at the Biomedical Research Institute of Malaga (Ibima) and president of the Spanish Society of Neurology (SEN). He is also an honorary professor at the Faculty of Medicine of the University of Malaga.

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