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A new generation of devices for the rapid, cheap and easy diagnosis of candidemia.

Candidemia is an infection caused by fungi of the genus Candida that is associated with high complication rates with a mortality that can reach 40%. A group of researchers have managed to develop a new material that allows for the rapid detection of candidaemia, with a sensitivity that exceeds 90% and a specificity greater than 95%.

Researchers from the CIBER-BBN (Center for Biomedical Research for Bioengineering, Biomaterials and Nanomedicine). the Polytechnic University of Valencia (UPV) and the La Fe Health Research Institute (IIS La Fe), with the participation of Unit 26 of NANBIOSIS NMR Biomedical Applications II, in collaboration with the Valencian startup MATCH Biosystems have developed a new generation of in vitro diagnostic devices (IVD), capable of improving current times, with high reliability and easy handling.

“The characterization of the anchored molecules as well as the final sensors were characterized using NMR equipment from NANBIOSIS unit 26”, explains Ramón Martínez Máñez, Scientific Director of NANBIOSIS Unit 26 of NMR Biomedical Applications of the University of Valencia and the CIBER-BBN

The group of researchers, led by Ramón Martínez Máñez, professor of Inorganic Chemistry at the Polytechnic University of Valencia and scientific director of the CIBER-BBN; and Javier Pemán, head of the Mycology Unit of the Microbiology Service of the Hospital Universitari i Politècnic La Fe, and head of the Severe Infection Research Group at IIS La Fe, decided to create MATCH biosystems in June 2020 with the objective of marketing in the future “the new generation of IVD devices capable of obtaining results for the diagnosis of candidemia in less than an hour in a reliable, easy way and without the need to go through a laboratory”, explains Adrián Teruel, CEO of the biomedical startup, pharmacist, doctor in nanomedicine.

Currently, the results of candedimia infection are obtained after carrying out cultures of the biological fluid in the laboratory, which can take between three and four days. With the new material and method patented by the researches’ institutions and developed by MATCH biosystems, the diagnostic time is drastically reduced.

“The tests are carried out very quickly, easily and without the need to enter a laboratory, which also reduces the equipment and personnel necessary to carry them out, with the consequent reduction in the expense that this implies for health public, in addition to allowing speed in making medical decisions that can save lives “, details Adrián Teruel.

The material used by MATCH biosystems is composed of dye-loaded porous supports and single strands of DNA, which act as molecular gates. The infection is detected when the single strands of DNA recognize the genetic material of the pathogen in the patient sample, at which point the molecular gates are opened and the dye is released, allowing the diagnosis to be carried out. The first sensors have already been developed and clinical tests have been carried out with real samples of patients, at the Hospital de La Fe.

MATCH biosystems is currently working on developing the complete kit that it expects to reach the market in a maximum of four years, in parallel with obtaining the relevant regulations and certifications.

The company has now focused on infections caused by candidemia, “but the field of application of the new devices also includes, in addition to the clinical, the veterinarian and the agri-food industry” says Teruel.

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Infections such as Candiasis will be detected in 30 minutes

Ramón Martínez Máñez, Elena Aznar and Ángela Ribes, researchers of Unit 26 of NANBIOSIS, NMR: Biomedical Applications II, in collaboration with researchers from the Universitat Politècnica de València, with the Universitari i Politècnic La Fe Hospital and the Rovira i Virgili University, have developed a new material that allows to detect quickly and with a high sensitivity infections caused by Candida albicans, a type of fungus that can be found in different biological fluids, causing opportunistic infections such as Candidemia or Invasive Candidiasis.

According to Javier Pemán, head of section and head of the Mycology Unit of the Microbiology Service of the Hospital Universitari i Politècnic La Fe,” infections are difficult to identify early, very frequent in most Intensive Care Units (ICUs) and represent an important challenge in critical patients”.

Currently, these infections are diagnosed by culturing the biological fluid to be studied and subsequent identification of yeast isolated by different microbiological techniques whose results can take between 3 and 4 days. Meanwhile, with this new material and method – patented by the UPV, the CIBER, the Hospital La Fe and the URV – the diagnostic time is reduced to only 30 minutes.

“The tests can be carried out quickly and practically in the same consultation in which the patient sample is taken, significantly reducing the equipment necessary to detect the presence of Candida albicans. Our work facilitates the diagnosis and medical decision-making, through the use of a powerful and fast tool to detect the infection”, says Ramón Martínez Máñez, scientific director of the CIBER-BBN and director of the IDM Institute at the UPV, as well as scientific director of NANBIOSIS U26.

Nanoporous films with molecular doors

The material developed by the CIBER-BBN research gourp, led by Ramón Martínez Máñez, is about nanoporous alumina films that incorporate “molecular doors” based on oligonucleotides. The characterization has been carried out in Unit 26 of NANBIOSIS, NMR: Biomedical Applications II.

“They are constituted by a porous inorganic support that is loaded with a dye and by simple strands of DNA. These strands are anchored to the surface of the support and act as “molecular doors” that inhibit the release of the indicator “, explains Ramón Martínez Máñez.

In addition, according to Professor Lluis Marsal, from the Rovira i Virgili University, the type of support used greatly simplifies the methodology of the experiment.

On how to detect the infection, Professor Martínez Máñez explains that the simple strands of DNA are selected taking into account a specific sequence of Candida albicans.

“When the presence of the DNA of this fungus is noticed, it interacts with the molecular door, the pores open and that is when the release of the dye that is inside the nanoporous support takes place, thus detecting the infection,” adds Elena Aznar , researcher of the CIBER-BBN in the IDM-UPV.

The diagnostic material is now in the clinical validation phase, thanks to the funding obtained through the CANDI-GATE project granted by the Polytechnic University of Valencia and the La Fe Health Research Institute and led by M. Angeles Tormo and Elena Aznar and through the CANDI-EYE valuation project granted by the CIBER-BBN and led by Elena Aznar.

Patent of reference:

“Porous material for the detection of Candida albicans, diagnostic method that uses it and method of preparation of it”. Spanish application pattent P201731069 2017-09-05.

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