PCR Diagnostics products
DIANA Biotechnologies has developed a series of ultra-sensitive PCR-based diagnostic tests to fight the COVID-19 epidemic. These are optimized to be run in diagnostic labs in high-throughput format. Our COVID-19 tests are currently in use at over 30 clinical laboratories in the Czech Republic and also being exported abroad. We have already produced more than 6 milion COVID-19 tests, covering 40 % of czech testing capacity.
Recently we have introduced to the market our novel technology DBdirect, allowing PCR detection directly from clinical samples (both nasopharyngeal swabs and saliva) without the need of prior isolation of RNA. DBdirect based saliva tests can revolutionize the COVID-19 testing, combining ultra-sensitive detection with the easy self-collection of the samples. These tests are suitable both for clinical diagnostics (CE IVD mark) and preventive screening programs.
- Parallel detection of SARS-CoV-2, Influenza A, Influenza B, RSV
- Manual and automated sample processing
- Ultra-sensitive analysis (LOD 2 to 10 copies depending on virus type)
- Design taking into consideration most recent virus sequences
- Tested for nasopharyngeal swabs and saliva
- Standard RT-PCR version and DBdirect™ version (without the need for RNA isolation)
- Easy self-collection of upto 1.2 ml of saliva sample
- CE-IVD marked – validated for in vitro diagnostics from saliva
- Compatible with 96 well-plate racks / automation
- 2D barcoded - unique ID on each tube
- More than 6 million tests performed
- Czech development and production
- Ultra-sensitive analysis (LOD 1 virus copy)
- 4 kit versions – enables optimal choice for every lab
- 2 detection methods: standard RT-PCR a DBdirect™ (direct RT-PCR without RNA isolation)
- 2 multiplex designs: they differ in the detected genes and in the possibility to differentiate virus variants
- Validated for diagnosis from nasopharyngeal swabs and saliva
- Suitable for manual and automated sample processing
DIANA Biotechnologies Diagnostic Pipeline
At DIANA Biotechnologies, we are pioneering the development of advanced diagnostic assays to address a wide range of health conditions. Our pipeline reflects our commitment to delivering innovative and reliable diagnostic solutions. See our future diagnostic prospects below:
| Category / Indication | Development status | Matrix | Highlights | |||||
| Tech development / Clinical research | Design / Pilot | IVD Development | RUO marketed, IVD validation | IVD marketed | ||||
| Respiratory pathogens | COVID-19 | YES | Swabs / Saliva | Direct PCR option | ||||
| COVID-19, Flu-A, Flu-B, RSV | YES | Swabs / Saliva | Mutiplex, Direct PCR option | |||||
| Sexually transmitted diseases (STD) | C. trachomatis, N.gonorrhoaea, M. genitalium | Urine / swabs | Multiplex | |||||
| M. hominis, U. urolyticum, U.parvum, T.vaginalis | Urine / swabs | |||||||
| Herpetic viruses | CMV | Whole Blood / Plasma / Urine | Quantitative, only two extra samples needed for each run (no need to run full calibration curve with each run) | |||||
| EBV | Whole Blood / Plasma / Urine | Quantitative, only two extra samples needed for each run (no need to run full calibration curve with each run) | ||||||
| HSV1, HSV2, VZV | ||||||||
| Papilloma viruses | HPV panel (16, 18, 45) | Blood / Saliva | Multiplex | |||||
| Human genetics | Thrombophilia - Factor II and Factor V leiden | Whole blood / Saliva | Multiplex | |||||
| Thrombophilia - higher multiplex | ||||||||
| Sepses - early diagnostics | S. aureus, E. coli, K. pneumoniae, P. aeruginosa | Blood (no cultivation) | FAST (result 3-4hrs after blood collection), Highly-sensitive, Unique sample processing, | |||||
| Higher multiplex | ||||||||
| Oncodiagnostics (Liquid Biopsy) | Pancreatic cancer (KRAS somatic mutations) | Plasma / Urine / Stool | Unique somatic mutation detection tech | |||||
