Commercialisation of Lab-on-a-Chip technology for DNA profiling

DNA分析是目前在英国用于调查和打击犯罪的最重要和不断发展的技术之一。英国数据库建立于1995年，是世界上人均人口最多的数据库，目前拥有不到500万份个人档案，基于短重复DNA序列，提供5000万分之一的鉴别能力。目前，在英国，DNA分析被用于解决大约5万起案件，或每年每300起记录在案的案件中就有一起。但是，如果从收集样本到获得侧写所花费的单位成本和时间可以从目前的几天缩短到几小时，那么这项技术在支持警方调查方面的有效性和使用就可以大大提高。2006年7月，由EPSRC在其“思考犯罪”倡议（EP/D040930）下资助的一个雄心勃勃的三年项目在赫尔大学开展，旨在开发一种基于微流体的芯片实验室系统，该系统可用于在犯罪现场获取DNA档案。这项工作已经成功地设计和制造了微流体芯片和相关的控制系统，能够从一系列样品类型中提取DNA（注意在芯片外进行细胞裂解以释放DNA），对多重样品进行PCR扩增，然后在大约2小时内分离和检测产物。用于执行此分析的芯片没有活动部件（试剂和样品通过电场泵送），并且芯片上包含所有凝胶中的试剂，避免了污染的可能性，因为一旦样品放置在芯片上并密封，任何物质都不会进入或离开设备。微流体装置是2008年10月提交的英国专利申请（申请号0818609.0）的主题，由玻璃（长120毫米，宽60毫米，深2毫米）制成，适合定制的仪器，大约是家用微波炉的大小（长60厘米，宽30厘米，高40厘米），控制DNA谱的生成（移动，放大和分离/检测）。然而，在目前的项目中已经达到了原理验证阶段，申请人现在非常热衷于让警方在打击犯罪的过程中使用这项技术。在与法医科学服务部一起进行了初步的市场和知识产权评估后，我们确定了调整方法以提供基于监护套件的技术的想法，允许在两小时内从口腔（口腔）拭子样本中进行DNA分析，这是一项重大需求，在对当前的控制仪器和芯片进行微小修改后可以实现。由于所需试剂的数量非常少，因此可以以具有竞争力的价格获得DNA图谱。对市场竞争对手和潜在阻碍知识产权的初步评估表明，存在一个很好的机会来开发拟议的技术，这将解决一个独特的市场插槽。因此，资金将用于支持所需的技术修改，以便将目前的技术转化为一个示范系统，以供保管使用。后续提案还将允许保留具有专业实践技能和技术知识的关键研究人员，他们将获得商业化和产品开发方面的额外技能。此外，还将制定一项更全面的操作自由研究和商业计划，以将这项工作推进为全面的商业活动。在这一提议的背景下，重要的是要强调，鉴于目前对不断增长的DNA数据库的强烈强调，英国代表了一个理想的地点，在那里推出拟议的新技术。很明显，在国际上，DNA指纹和生物识别分析是一个新兴领域，早期的市场主导地位将为英国提供一个主要的产品基础，以应对日益增长的法医和相关应用的全球舞台。

DNA profiling represents one of the most important and growing techniques currently use in the UK to investigate and fight crime. Established in 1995 the UK data base, which is the world's largest per head of population, currently holds just under 5 million individual profiles, based on short repeating DNA sequences, offering a discriminating power of one in 50 million. At present DNA profiling is being used to solve around 50,000, or one in every 300 recorded crimes per year, in the UK. The effectiveness and use of the technique in supporting police investigations could however be significantly improved if the unit cost and time taken from collecting a sample to obtaining a profile could be shortened from the current days to hours. In July 2006 an ambitious three year project, funded by the EPSRC under its 'Think Crime' initiative (EP/D040930), was undertaken at the University of Hull to develop a micro fluidic based Lab-on-a-chip system which could be used to obtain DNA profiles at the scene of a crime. The work has seen the successful design and fabrication of micro fluidic chips and associated control system, that is able to extract DNA from a range of sample types (note cell lysis performed off chip to release DNA), perform PCR amplification of a multiplex sample and then separate and detect products in approximately 2 hours. The chip used to perform this analysis has no moving parts (reagents and sample are pumped by electric fields) and contains all the reagents in gels on chip, avoiding the possibility of contamination as once the sample is placed on the chip and sealed nothing enters or leaves the device. The micro fluidic device which is the subject of a UK patent application submitted in October 2008 (Application No. 0818609.0) is made of glass (120mm long, 60mm wide and 2 mm deep) and fits into a custom built instrument, about the size of a domestic microwave (60cm long, 30cm wide and 40 cm high), that controls the generation of the DNA profile (movement, amplification and separation/detection). However having reached the proof of principle stage in the current project the applicants are now very keen to make the technology accessible to the police in their fight against crime.Having carried out an initial market and IP evaluation in conjunction with the Forensic Scientific Service the idea of adapting the methodology to provide a custody suite based technology, allowing DNA profiling in under two hours from a buccal (mouth) swab sample, has been identified as a significant need which is realistically achievable following minor modifications to the current control instrument and chips. The DNA profile would be achieved at a competitive price due to the very small amounts of reagents required. An initial evaluation of market competitors and potentially blocking IP has indicated that a good opportunity exists to develop the proposed technology which will address a unique market slot. Accordingly funding will be used to support the technical modifications required to convert the current technology into a demonstrator system for custody based use. The Follow-on proposal will also allow retention of key research personnel with specialised practical skills and technical knowhow, who will gain additional skills in commercialisation and product development. Furthermore a more comprehensive freedom to operate study and business plan will be produced to carry the work forward into a full commercially-based activity. In the context of this proposal it is important to stress that given the current strong emphasis being place on a growing DNA database the UK represents an ideal location in which to launch the proposed new technology. It is clear also that internationally, DNA fingerprinting and biometric analysis represents an emerging field and early market dominance will clearly offer the potential to develop a major UK product base to address a growing global arena for forensic and related applications.