Inside track

The IVDR regulation (EU 2017/746) fundamentally changes the rules in the field of in vitro diagnostics. While in the past, certain aspects of method validation could be approached in a more laboratory-driven and flexible way, it is now necessary to document every step clearly and link it to regulatory requirements. At GENERI BIOTECH, we welcome

At the end of August 2025, we returned to organizing our Science Clubs. These events were held regularly in the past decade, and after last year’s relocation and settling into our new premises, we realized that we were missing such a platform. A platform for education and discussion with elements of brainstorming—an opportunity to share

In the past few days, GENERI BIOTECH has been overwhelmed with inquiries regarding SRY testing — either about the availability of SRY gene detection kits or the possibility of conducting the full analysis. We have found that the International Athletics Federation will introduce, as of September 1, 2025, a one-time test for the presence of

We are very pleased to announce that GENERI BIOTECH has entered August as a fully re-certified company. This has been a very busy period. It was only at the end of April when we completed moving of our entire manufacturing facilities, and in just three months we have implemented new manufacturing technologies and successfully passed

Lecanemab belongs to the antibody-based treatment approach as might be easily derived from its name Lecanemab where specifically the mab end cap refers to a monoclonal antibody. Lecanemab is registered commercially as Leqembi® and it has been approved by the FDA (Food and Drug Administration) in an accelerated approval pathway in January 2023 however this status changed in the summer of this year when the FDA converted the Leqembi® to traditional approval [1], [2]⁠.

Dihydropyrimidine dehydrogenase (DPD; coded by the DPYD gene) is an initial and rate-limiting enzyme of uracil catabolism, consequently essential for elimination of fluoropyrimidine-based chemotherapeutics (fluorouracil, capecitabine, tegafur, flucytosine).

Most current oncolytic viruses are engineered for selective recognition of cancer cell, although there are naturally occurring examples (e.g. reovirus), number of different viruses are used in clinical trials (adenovirus, vaccinia, etc.).

PCR users have sometimes trouble with their real-time PCR experiments. Their real-time PCR curves give no signal or they have complication with signal in negative control. We will try to help users with the main reasons of your PCR troubles and how to solve them.

Genetic polymorphism of cytochrome 450 (CYP) drug-metabolizing enzymes leads to inter-individual variability in the plasma concentrations of many drugs. Inter-individual variability among patients is a major clinical problem, as it can cause serious adverse drug reactions or therapeutic failures.

All medical devices, even when used appropriately, present a certain degree of risk to patients. Therefore, they have to be evaluated for their biocompatibility according to international harmonized standard ISO 10993-5 – Biological evaluation of medical devices, Part 5: Test for In Vitro Cytotoxicity.

Background Probiotics are defined as live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. For instance, probiotics can be used in the treatment and prevention of infections and chronic inflammatory disorders of the gastrointestinal tract. Due to their health attributes, probiotics generate considerable interest in the area of functional

The avermectins compose a class of polycyclic lactones that are used to treat parasitic worms and insect pests. They are naturally occurring compounds generated in a fermentation process by a soil actinomycete Streptomyces avermitilis.