SCM BIOTECHNOLOGY Co. R & D

Development of HPV Diagnostic Kit

Human Papilloma Virus (HPV), a DNA virus, causes genital warts or cervical cancer. Today, the diagnosis of HPV which is accepted as the main factor for cervical cancer is very important because it is a preventable cancer type. Especially in the treatment of diseases caused by this virus, as in many other diseases, screening, early diagnosis and treatment are of great importance.

Cervical cancer has been defined by the World Health Organization as a preventable cause of death and has been shown as a preventable health problem. Today, the scope of HPV testing is quite advanced. Various HPV screening kits are used in the market. However, these HPV screening kits used have many disadvantages. Some of these disadvantages are; the number of types they scan can vary, scanning very few types, high cost of those who scan more types, long analysis time, complex analysis methods and requiring expertise. With the HPV diagnostic kit to be developed within the scope of the project, these disadvantages will be prevented and many advantages such as simultaneous multi genotyping, short analysis time, low cost, high sensitivity, ease of use and being the first domestic product.

Development of DNA/RNA Extraction Kit Compatible with Automatic Nucleic Acid Extraction Device

Global health and food security is constantly faced with human and plant diseases caused by bacteria, viruses, fungi and other pathogens. Epidemics such as SARS, MERS, Swine Flu, Ebola and COVID-19 have caused great death and economic losses worldwide. Molecular diagnosis of human and plant diseases has became increasingly important to prevent the spread of disease and protect human populations. Nucleic acid-based molecular diagnosis reveals valuable information at the genomic level about the identity of disease-causing pathogens and their pathogenesis. This helps researchers, healthcare professionals and patients detect the presence of pathogens, monitor and guide the spread of disease.

Nucleic acid extraction (NAE) is one of the most important steps in molecular biology, which is routinely used in many fields of biological and medical sciences. Because this procedure is a starting point in any molecular diagnostic kit. This important procedure has been known for more than a century and has been significantly improved over the last decade. However, some progress still needs to be made for *point-of-care diagnostics* applications, which are the laboratory phases of NAE protocols.

Within the scope of this project; It produced to produce a domestic commercial kit, that can be used in the isolation of pure viral and genomic NA from samples such as blood, serum, plasma, human nasopharyngeal swabs, sputum, broncho lavage fluid and alveolar lavage fluid, and also this kit can work in harmony with magnetic particle purification technology. NAs obtained using the developed NAE kit can also be used in PCR/RT-PCR, sequencing, polymorphism analysis and other molecular-based analyzes.

Rare V1

Rare diseases are diseases with a frequency of less than 1:2000. There are about 8,000 species of rare diseases and about 80% of them are of genetic origin. The incidence of these diseases are varied according to the characteristics of the country, region and society. Studies are shown that the incidence of rare diseases in the population is actually higher than the existing figures due to the lack of diagnosis. Lysosomal storage diseases (LSD; the most common types Fabry, Krabbe and Niemann-Pick), which are rare diseases that have been given importance all over the world in recent years, are seen as a deficiency of a specific enzyme and/or lysosomal component in the body. According to the Health Practice Communiqué, these diseases are diagnosed according to the measurement of the enzyme level or the compatibility of the mutation analysis and both methods are approved for the diagnosis of the disease in the communique. Even if both methods are approved for the diagnosis of the disease in the communique, the measurement of enzyme level is more important than mutation analysis that used only for detection at the gene level. The importance of enzyme level measurement is related with if enzyme is not sufficiently produced or given to the environment in a functional state. Diagnosis and treatment of these diseases are difficult all over the world. ELISA kits are avaible in the world markets are used in the diagnosis of the these disease and are seperatly available in the world for each these disease. However, there is no locally produced kit.

Within the scope of this project, the ELISA test system to be developed for the diagnosis of Fabry, Krabbe and Niemann-Pick diseases will enable the development of diagnostic kits in different fields, as well as producing high value-added diagnostic technology for our country. With this project, it is aimed to eliminate the socio-economic burden caused by rare diseases, to diagnose easily and accurately, to produce information and develop methods that can be effective in the transition to rapid treatment or prevention of diseases.

Development of a Holistic Approach to the Diagnosis and Follow-up of SMA Disease

Spinal Muscular Atrophy (SMA) is a rare neuromuscular disease that causes progressive symmetrical muscle weakness and atrophy, characterized by loss of lower motor neurons in the spinal cord and brainstem nuclei, caused by deletions or mutations in the spinal motor neuron gene. While the carrier rate of SMA disease in the world varies between 1 in 35 and 1 in 50, its incidence is 1 in 6000 live births. Although SMA is diagnosed by the presence of deletions and mutations in SMN1, some studies have shown that variability in clinical presentation is depended on the presence of a neighboring and nearly identical gene, SMN2.

Within the scope of this project, new generation sequencing (NGS) method to be used in the diagnosis of SMA and diagnostic kits used with RT-PCR method, which gives successful results especially in newborn screening, will be developed. In addition, it is also aimed to develop an ELISA screening kit that will measure the total SMN protein level, which can be used both in the diagnosis of SMA and in the follow-up of this disease.