Periodic Reporting for period 3 - Bio-LP-1 (A novel rapid environmental test for the human pathogen Legionella)
Periodo di rendicontazione: 2022-04-01 al 2022-07-31
Legionnaires Disease (LD) is a severe and often fatal form of pneumonia which is caused by bacteria known as Legionella that are predominantly transmitted through contaminated water systems. Globally the incidence of LD is increasing in many parts of the world and outbreaks of LD associated with water contamination are rising. The most effective way to limit the spread of LD is to control and eliminate the bacteria from environmental reservoirs. At present the most commonly used tests for Legionella detection in water are time consuming (14 days) and lack specificity and sensitivity.
BioProbe Diagnostics' (BPD) lead product, Bio-LP-1, is a revolutionary real-time PCR test which has the capability to transform Legionella environmental testing globally. Bio-LP-1 allows for the rapid (< 5 h from sample in to result out), sensitive, quantitative detection and identification of Legionella, L. pneumophila and L. pneumophila sg1 in a single water sample. The final stages of product development have been completed successfully and Bio-LP-1 is ready for commercialisation, leading to sales of the product in the EU by Q3, 2022 and the US by 2024.
BioProbe Diagnostics' (BPD) lead product, Bio-LP-1, is a revolutionary real-time PCR test which has the capability to transform Legionella environmental testing globally. Bio-LP-1 allows for the rapid (< 5 h from sample in to result out), sensitive, quantitative detection and identification of Legionella, L. pneumophila and L. pneumophila sg1 in a single water sample. The final stages of product development have been completed successfully and Bio-LP-1 is ready for commercialisation, leading to sales of the product in the EU by Q3, 2022 and the US by 2024.
The main objectives of the project were to complete all the steps required to finalise Bio-LP-1 development and ensure the successful market launch of the product. The optimisation of all Bio-LP-1 kit components and the internal validation of the product were successfully completed and the product is ready to proceed with certification. A large-scale manufacturing process was developed by myP and BPD. This includes several adjustments and improvements and all the quality control steps required to maintain a high-quality standard production of the kit. A plan for conducting stability test, shelf life and storage condition studies is also in place. Over 40,000 lyocakes were manufactured in independent batches that were used for the internal validation experiments carried out by BPD, large customer trials carried out by CMB and certification of Bio-LP-1.
To be able to successfully bring the Bio-LP-1 product to the market, a commercialisation plan was developed. This included all the available information regarding requirements for product launch in Europe and US and environmental and economic benefits of the product compared to the gold-standard culture method. Major water testing laboratories were identified as end users of Bio-LP-1 in selected European countries. A product launch plan was also developed that included an implementation plan for marketing activities and the supporting marketing materials to start the commercialisation of the Bio-LP-1 product in the EU market by Q3 2022. An initial phase of these plan included creating awareness of the product’s benefits among target customer groups. The next phase focused on achieving and growing product sales once the project was completed. An email campaign carried out by Labor Praxis in the German speaking region. Over 100 leads were generated, potential customers are currently testing the Bio-LP-1 kit and conversations are ongoing to complete the first product sales.
A large-scale customer trial, that included the analysis of different water types using Bio-LP-1 and the traditional culture method, was carried out by CMB. The main aim of this trial was to demonstrate the benefits of using the Bio-LP-1 kit over the culture method. The overall results from the trail were very positive, Bio-LP-1 is highly specific for Legionella spp., and it showed a higher sensitivity than the culture method, being able to detect the bacteria even when the concentration of Legionella present in the water sample was very low. Bio-LP-1 has a faster turnaround time to results, with less than 5 hours compared to 10-15 days for culture testing. The traditional culture method is slow and tedious, requires highly experienced technicians, and generates large volumes of non-recyclable materials which means higher waste management costs and a negative environmental impact. The results from the customers’ trial will be published in an international open access peer-reviewed journal and will be used for the development of marketing and promotional materials.
To be able to successfully bring the Bio-LP-1 product to the market, a commercialisation plan was developed. This included all the available information regarding requirements for product launch in Europe and US and environmental and economic benefits of the product compared to the gold-standard culture method. Major water testing laboratories were identified as end users of Bio-LP-1 in selected European countries. A product launch plan was also developed that included an implementation plan for marketing activities and the supporting marketing materials to start the commercialisation of the Bio-LP-1 product in the EU market by Q3 2022. An initial phase of these plan included creating awareness of the product’s benefits among target customer groups. The next phase focused on achieving and growing product sales once the project was completed. An email campaign carried out by Labor Praxis in the German speaking region. Over 100 leads were generated, potential customers are currently testing the Bio-LP-1 kit and conversations are ongoing to complete the first product sales.
A large-scale customer trial, that included the analysis of different water types using Bio-LP-1 and the traditional culture method, was carried out by CMB. The main aim of this trial was to demonstrate the benefits of using the Bio-LP-1 kit over the culture method. The overall results from the trail were very positive, Bio-LP-1 is highly specific for Legionella spp., and it showed a higher sensitivity than the culture method, being able to detect the bacteria even when the concentration of Legionella present in the water sample was very low. Bio-LP-1 has a faster turnaround time to results, with less than 5 hours compared to 10-15 days for culture testing. The traditional culture method is slow and tedious, requires highly experienced technicians, and generates large volumes of non-recyclable materials which means higher waste management costs and a negative environmental impact. The results from the customers’ trial will be published in an international open access peer-reviewed journal and will be used for the development of marketing and promotional materials.
LD is a serious and growing disease with considerable negative impacts on EU citizens. Legionella infections have been increasing worldwide and will continue to rise due to multiple factors that include ageing population and increasing global temperatures. Bio-LP-1 will provide a solution to address several pain points experienced by end-users and the Legionella testing sector, while addressing the greater global problem of reducing the current expansion of Legionnaires’ disease. Bio-LP-1 allows for the rapid, sensitive, quantitative detection and identification of Legionella spp., L. pneumophila and L. pneumophila sg1 in a single water sample. This represents significant savings for testing laboratories and increased revenues through higher testing throughput. By using Bio-LP-1, customers can obtain results in just a few hours that would enable them to determine when remedial actions are required, while also monitoring if these corrective actions are being effective. This will result in financial savings and will avoid unnecessary ward closures. The use of Bio-LP-1 will ensure water safety and will lead to a reduction in healthcare associated infections. Bio-LP-1 will improve patient outcomes through a reduction in morbidity and mortality and will also decrease health care costs and economic costs associated with Legionella outbreaks.