Manufacturing IVD test for GENOMICA

According to recent estimates, the global incidence rate for curable sexual transmitted infections (STIs) per year, such as those with Treponema pallidum (Syphilis), Neisseria gonorrhoea (Gonorrhea), Chlamydia trachomatis and Trichomonas vaginalis (Trichomoniasis), is more than 350 million cases. Viral sexual transmitted infections show similar rates and infections with Herpex simplex type 2 only exceed an estimated prevalence rate of 415 million cases.

In 2016, the World Health Organization (WHO) has published its Global Health Sector Strategy on Sexually Transmitted Infections 2016–2021 – with the overarching objective of ending STIs as a public health problem. Addressing several issues in this field, the WHO paper also emphasized that early diagnosis of sexually transmitted infections, including those without symptoms, is the best opportunity for effective medical treatment and support, and for preventing further transmission.

 

 

 

 

With the goal of providing a comprehensive and reliable diagnostic tool to simultaneously detect the most common pathogens causing STIs, GENOMICA and SCIENION have jointly developed a novel multiplex test that combines both companies’ expertise and technologies. SCIENION contributes its proprietary sciFLEXARRAYER non-contact printing technology and consumables, such as sciPLEXPLATES, while GENOMICA applies that technology, combining it with a multiplex PCR, CLART® Technology, allowing the simultaneous detection of bacteria, virus, fungi and parasites on a Low Density Microarray format.
SCIENION manufactures the IVD tests that allow for the identification and specific differentiation of 18 microorganisms causing STIs.


"We have been using SCIENION manufacturing printing services to produce our CLART® product line. CLART® is a low density well-based microarray platform for clinical use that allows the detection of multiple targets in a single test. This technology, jointly developed between SCIENION and GENOMICA, has enabled us to meet high quality standards and a flexible production schedule."

Dr. María Luisa Villahermosa, R&D Director