Our systems support near-patient (point-of-sample) testing for routine diagnosis, but also to support Clean Zone creation and management, patient and staff ‘track and trace’ and any other applications requiring real-time detection of a bio-hazardous agent in a clinical or environmental setting.
No cold chain – recyclable, interchangeable cartridges are produced in sterile, clean laboratories using quality reagents and carefully optimised mixtures. These are stabilised for shipping and storage with a minimum shelf-life of one month, up to 6 months depending on storage conditions.
Adaptable Tester – may be used by industry or health enterprises, for single- and multi-Target or for single- and multi-Subject tests.
User protection – the PNA™ workflow includes a two-tier safety system to inactivate bio-hazards prior to analysis, and then physically sealing these inside the unit. Spent assays may be further examined in specialist laboratories.
Reliability in a rugged, low-cost tester, in an IP53 case.
The BioSystems Assure PNA™ platform gives users the ability to detect and measure biological agents using high integrity genetic sequence-based analysis methods, without the need for a laboratory or specialist scientific and technical staff. PNA™ was conceived as a rapid and convenient method for sensitive and specific detection of the bacterium Escherichia coli (E. coli), which is used universally as an indicator of the presence faecal contamination of water and food. It has since been developed into a robust, affordable and portable instrument, using pre-prepared, disposable sample packs containing everything required to undertake multiple measurements in the field, in a few simple steps.
Our patented platform is fully customisable according to the specific requirements of the end-user, and can be readily adapted to the detection of any biological agents in solid, liquid or gaseous samples using a range of low-cost peripherals and sample-preparation ‘kits’. The sample is neutralised to ensure that any threat may be detected safely, reliably and without the need for a laboratory.
This is a Cross-Over Technology
- Methodology, Instrumentation and Process borne from world-leading Environmental Science research*
- Built for the surveillance of ‘hard to measure’ bio-hazards (low concentration targets in samples which inhibit PCR, e.g. the ocean, sediments and contaminated natural waters).
- Suitable for applications from the environment to health.
- Clinical samples would typically contain high levels of target genetic material, orders of magnitude more than existing Limits of Detection.
- Clinical samples (eg. Blood, Saliva) are intrinsically ‘bio-assay’ compatible.
*The National Oceanography Centre (UK) is one of top oceanographic institutions world-wide, which provides the majority of the UK national capability for marine science. Source: www.noc.ac.uk.
Mission proven methodology
There are 3 principle ‘molecular’ innovation areas that make our system state of the art
(1) Faster, Efficient PCR
- Minimal volumes, rapid cycling
- Recombinant enzymes
- Robust, 2-layer specificity lock
- Fluorometric real-time read-out
(2) Gold Standard Assay Design
- Next Generation Sequence data
- ‘Variant’ tolerant/SNP detection
- Linear response
- Qualitative and quantitative
- ‘Traffic Light’ threat warning
(3) Stabilised, Ready Mixed Assays
- User adds sample to activate
- No cold chain
- No user error
- No cross contamination
- BSA will follow a rigorous approach through verification and validation to suitable regulatory and business standards including ISO9001, CISA, ISO13485, ISO14000, ISO27000 and GAMP®5.
- Letter of Intent to Grant received.