Periodic Reporting for period 2 - Themis (Disruptive solution for sexual criminal identification)
Berichtszeitraum: 2021-07-01 bis 2022-12-31
Rape is a global scourge and, unlike blood, no efficient solution is offered today to Crime Scene Technicians (CST) and forensic pathologists to find sperm traces directly on the scene and on victims’ body. About 65% of reported rape cases remain unpunished and sexual predators -most of the time repeat offenders- run free.
AXO Science has demonstrated a new product proof of concept: STK Spray, a revealing semen-specific reagent with broad detection capacity of sperm traces on any floor, grass, wall, object, skin, hair…). It preserves DNA for further identification in the laboratory. Formulated in a convenient format, where dry powder is simply dissolved in water, product is rapidly ready-to-spray and easy to carry. After a few sprays, STK Spray will make semen traces in a bright blue colour. Only human male semen is revealed, providing only qualified sample. No false positive and no evidence left being because of inefficient Alternate Light Source, a premiere.
With this project, AXO Science has prepared market introduction for this disruptive solution. STK Spray is a game-changer and will revolutionise CST toolbox and the way rape investigation are being handled by Police forces. Disruption lies in the dramatic acceleration of procedures – both police and justice – and the increased number of traces found (100% versus 10% currently). It will thus drastically increase the number of solved cases (+30%).
AXO Science brings its technology outside laboratories, to the very hands of crime technicians on site. More than a leading product, AXO Science wants to push the use of STK as a reflex for any Forensic Expert who faces potential presence of sperm traces whatever the location or surface.
Within 2 years AXO Science will almost double its original size both with regards to human resources and product portfolio.
STK Spray performances demonstration and validation in operational environment are now achieved. Project permitted to drastically accelerate the time to market. STK Spray is now available to help forensic experts all over the world fighting sexual assault pandemic.
AXO Science has demonstrated a new product proof of concept: STK Spray, a revealing semen-specific reagent with broad detection capacity of sperm traces on any floor, grass, wall, object, skin, hair…). It preserves DNA for further identification in the laboratory. Formulated in a convenient format, where dry powder is simply dissolved in water, product is rapidly ready-to-spray and easy to carry. After a few sprays, STK Spray will make semen traces in a bright blue colour. Only human male semen is revealed, providing only qualified sample. No false positive and no evidence left being because of inefficient Alternate Light Source, a premiere.
With this project, AXO Science has prepared market introduction for this disruptive solution. STK Spray is a game-changer and will revolutionise CST toolbox and the way rape investigation are being handled by Police forces. Disruption lies in the dramatic acceleration of procedures – both police and justice – and the increased number of traces found (100% versus 10% currently). It will thus drastically increase the number of solved cases (+30%).
AXO Science brings its technology outside laboratories, to the very hands of crime technicians on site. More than a leading product, AXO Science wants to push the use of STK as a reflex for any Forensic Expert who faces potential presence of sperm traces whatever the location or surface.
Within 2 years AXO Science will almost double its original size both with regards to human resources and product portfolio.
STK Spray performances demonstration and validation in operational environment are now achieved. Project permitted to drastically accelerate the time to market. STK Spray is now available to help forensic experts all over the world fighting sexual assault pandemic.
AXO Science has structured its work force and competences to be able to reach its targets and objectives. In the context of Covid-19 pandemic, company and project management has played a crucial role to limit crisis negative impact. Besides the recruitment of an American based forensic expert was done to promote STK Spray solution in North America.
AXO Science Ethic Committee was created in order to validate procedures for volunteer recruitment and data treatment. Regulation was studied to ensure that procedures and reference documents (supporting documentation, contractual documents, forms, templates, guidelines, and consent agreement forms) were compliant with the laws.
Regarding norms, focus on maintaining the ISO 9001 (quality management system; QSM) standards and implement ISO 18385 (DNA free contamination) was done. Also regular reviews were performed to monitor evolution of risks.
Regarding product development, great effort was made on performance characterisation. Exhaustive performance evaluation, including sensibility, specificity over a wide material range, as well as compatibility with other forensics products was performed. Correlation between quantity and quality of human DNA recovered has been shown. It includes sensitivity and sensibility tests, a cross contamination extensive study, verifying the absence of unspecific signal with: faeces, blood, vaginal secretion, urine, saliva. Based on the first positive results, a patent deposition was made to protect our innovation.
Evaluation of technical materials (forensic lamps) to be used with STK Spray was launched in order to be able to recommend best UV lamp for STK Spray to end-users. More than 15 commercial UV lamps were tested in combination with STK Spray. On field testing with selected portable UV lamps was performed showing usage in a close-to-real environment. A complete stability study was launched, including storage and packaging effects on product performances. Additionally, a specific study has started in order to create our own specific UV lamp.
As an important product variation, STK Skin has been developed for usage on non-deceased victims, over skin and hair. Regulation report for STK Skin, defining the applicable regulation and tests to be produced for a skin contact use was achieved. The capacity to localize semen stain and to recover male DNA over the skin of a victim was successfully demonstrated. This product will be addressed to forensic examiners.
Based on these positive results, transfer to industrialisation has been implemented. Complete technical processes and protocols in order to produce STK Spray has been generated and validated. In an effort to modernise and secure current infrastructures and to scale-up production, implementation of tools and infrastructures for clean room and human DNA free environment was achieved. Facilities and process has been validated for ISO18385. Production and qualification workflow is now ready for entering in routine production.
Worldwide communication and demonstration effort was started over the last year despite international lockdown. Finally, AXO Science participated to 18 Exhibitions all over the world. A great part of the dissemination effort has been on the identification of key opinion leaders (KOL). We identified four worldwide KOL’categories: Forensic Instructors/Trainers, Distributors (crime scene suppliers), Associations & Universities, Public bodies (Justice & Public Safety departments, general attorneys). Amongst them, more than 60 worldwide KOLs were identified and directly contacted to exchange about STK Spray and Skin innovation. Today more than 250 persons from the scientific community have been reached.
Experts and KOLs feedback on STK Spray has been successfully considered to improve the product, the documentation and recommendation for future users.
Scientific publications, peer-reviewed, conferences talks and scientific posters were published by first users, improving STK Spray visibility and confirming its great benefit for sexual aggression fight.
AXO Science Ethic Committee was created in order to validate procedures for volunteer recruitment and data treatment. Regulation was studied to ensure that procedures and reference documents (supporting documentation, contractual documents, forms, templates, guidelines, and consent agreement forms) were compliant with the laws.
Regarding norms, focus on maintaining the ISO 9001 (quality management system; QSM) standards and implement ISO 18385 (DNA free contamination) was done. Also regular reviews were performed to monitor evolution of risks.
Regarding product development, great effort was made on performance characterisation. Exhaustive performance evaluation, including sensibility, specificity over a wide material range, as well as compatibility with other forensics products was performed. Correlation between quantity and quality of human DNA recovered has been shown. It includes sensitivity and sensibility tests, a cross contamination extensive study, verifying the absence of unspecific signal with: faeces, blood, vaginal secretion, urine, saliva. Based on the first positive results, a patent deposition was made to protect our innovation.
Evaluation of technical materials (forensic lamps) to be used with STK Spray was launched in order to be able to recommend best UV lamp for STK Spray to end-users. More than 15 commercial UV lamps were tested in combination with STK Spray. On field testing with selected portable UV lamps was performed showing usage in a close-to-real environment. A complete stability study was launched, including storage and packaging effects on product performances. Additionally, a specific study has started in order to create our own specific UV lamp.
As an important product variation, STK Skin has been developed for usage on non-deceased victims, over skin and hair. Regulation report for STK Skin, defining the applicable regulation and tests to be produced for a skin contact use was achieved. The capacity to localize semen stain and to recover male DNA over the skin of a victim was successfully demonstrated. This product will be addressed to forensic examiners.
Based on these positive results, transfer to industrialisation has been implemented. Complete technical processes and protocols in order to produce STK Spray has been generated and validated. In an effort to modernise and secure current infrastructures and to scale-up production, implementation of tools and infrastructures for clean room and human DNA free environment was achieved. Facilities and process has been validated for ISO18385. Production and qualification workflow is now ready for entering in routine production.
Worldwide communication and demonstration effort was started over the last year despite international lockdown. Finally, AXO Science participated to 18 Exhibitions all over the world. A great part of the dissemination effort has been on the identification of key opinion leaders (KOL). We identified four worldwide KOL’categories: Forensic Instructors/Trainers, Distributors (crime scene suppliers), Associations & Universities, Public bodies (Justice & Public Safety departments, general attorneys). Amongst them, more than 60 worldwide KOLs were identified and directly contacted to exchange about STK Spray and Skin innovation. Today more than 250 persons from the scientific community have been reached.
Experts and KOLs feedback on STK Spray has been successfully considered to improve the product, the documentation and recommendation for future users.
Scientific publications, peer-reviewed, conferences talks and scientific posters were published by first users, improving STK Spray visibility and confirming its great benefit for sexual aggression fight.
STK Spray product is a straightforward semen detection technique with an increased sensitivity and specificity compared to existing methods. Its use will revolutionize screening processes in every sexual aggression cases. Current forensic organisations have major drawbacks in fighting rapes that STK Spray will drastically improve. We anticipate an increase of 40% of the investigation success rate. It will have a huge impact on society and sexual violence occurrence. Potential positive impact over society is enormous. Sexual aggressions have massive direct and indirect costs over victims and society; their reduction is definitely a target in our modern society.
On a business, estimated number of customers for STK Skin, in western countries, is 650 entities and 6 700 forensic physicians performing 115 000 analyses related to rape each year.
AXO Science anticipates to capture a global market share of 23% in 2025 of the global semen screening market. Among STK Spray sales, STK Skin shall represent 16% of sales.
In 2023, after 3 years of marketing and communication activities across the world, the product is now really taking off and expanding on new markets.
On a business, estimated number of customers for STK Skin, in western countries, is 650 entities and 6 700 forensic physicians performing 115 000 analyses related to rape each year.
AXO Science anticipates to capture a global market share of 23% in 2025 of the global semen screening market. Among STK Spray sales, STK Skin shall represent 16% of sales.
In 2023, after 3 years of marketing and communication activities across the world, the product is now really taking off and expanding on new markets.