Assets listed in Biotechgate are grouped into four sections: therapeutics, molecular diagnostics, medical devices and technologies. The divide is rather logical, but for some users, especially those familiar with the classification of products for regulatory purposes, it may not be clear how we distinguish molecular diagnostics from diagnostic medical devices. In this article, we discuss the criteria for assigning products to each of the two sections.
One of the main applications of Biotechgate is for the search of life science assets, either for business development purposes or as part of market research. Currently, we provide details of over 90,000 assets grouped into four sections:
In this article, we will focus on the Molecular Diagnostics section that was created in response to feedback received from the database users. Therefore, it may be worth clarifying the criteria for assigning assets to this section.
Broadly speaking, there are three types of diagnostic products:
- Diagnostic molecules (e.g. biomarkers, antibodies used as diagnostics)
- Diagnostic tests and kits (e.g. ELISA tests used as diagnostics, test stripes)
- Diagnostic devices (e.g. stethoscopes, USG machines)
One can argue that diagnostic tests and kits are diagnostic devices because they are regulated as a subclass of medical devices by most regulatory bodies worldwide. In fact, they are referred to as ‘In vitro diagnostic medical devices’ in legislative documents. However, it’s important to note that there are two regulatory paths for medical products – a path for drugs and a path for medical devices – whereas we have three types of products in Biotechgate. Therefore, the divide between types of products in our database will not coincide with the regulatory paths.
In Biotechgate we classify diagnostics products as follows:
- Diagnostic molecules and diagnostic tests/kits fall into the Molecular Diagnostics section
- Diagnostic devices (stethoscopes, USG machines, etc.) fall into the Medical Devices section
We believe this classification is intuitive and facilitates performing a search without nuanced knowledge of regulatory legislation. To make the distinction even clearer, we have recently renamed the first section from ‘Diagnostics’ to ‘Molecular Diagnostics’.
Sometimes it is hard to decide if a product is a molecular test or a medical device because the test is a part of a kit that includes a device, e.g. an electronic reader, lancet, probe, etc. If the innovation lies in the device rather than the molecular test, the kit will more likely be listed in the Medical Device section instead of Molecular Diagnostic section. An example is VG test to diagnose vaginal infections. It is called ‘test’ but in fact it is an ion mobility spectrometry machine that measures biogenic amines in the sample. Another example, Piccolo Express, is an analyzer to perform multi-chemistry blood test. The analyzer is a medical device in our understanding, however, the reagents used in it, would fall into molecular diagnostics.
It’s worth noting that searching Biotechgate for companies developing or providing diagnostics does not require an understanding of the distinction between molecular diagnostics and diagnostic devices. We have recently launched a multi-sector search that allows to select subsectors that not necessarily belong to the same main sector. This means that you can find all diagnostic companies by selecting Biotechnology – Therapeutics and Diagnostics>>Molecular diagnostics and Medical Devices>>Diagnostic devices in the same search.
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