CMOS-Integrated Fluorescence Biochip SBIR Phase II Grant Application

CMOS集成荧光生物芯片SBIR二期资助申请

• 批准号: 8906658
• 负责人: Arjang Hassibi
• 金额: $ 81.08万
• 依托单位: INSILIXA, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-09 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8906658
• 关键词: AIDS/HIV problem; Address; Adoption; Affect; Antibiotic Resistance; Antibiotic susceptibility; Antibiotics; Antimicrobial Resistance; Antiviral Agents; Applications Grants; Arts; Bacteria; Biological Assay; Blood; Characteristics; Clinical; Communicable Diseases; Computer software; DNA; Detection; Development; Development Plans; Devices; Diagnostic; Drug resistance; Electronics; Enterobacteriaceae; Extreme drug resistant tuberculosis; Fluorescence; Funding; Genomic DNA; Genotype; Goals; HIV; Health Care Costs; In Vitro; Infection; Infectious Agent; Laboratories; Methods; Microbe; Multi-Drug Resistance; Mutation; Mycobacterium tuberculosis; Nosocomial Infections; Nucleic Acid Amplification Tests; Organism; Outcome; Outpatients; Patients; Pattern; Pharmaceutical Preparations; Phase; Predisposition; Process; Reaction; Reader; Recurrence; Resistance; Resistance profile; Resolution; Resources; Respiratory Tract Infections; Sampling; Semiconductors; Silicon; Small Business Innovation Research Grant; Solutions; Specimen; Technology; Testing; Time; Tube; Tuberculosis; United States National Institutes of Health; Urinary tract; Urinary tract infection; Validation; Viral Load result; Work; base; biochip; clinical decision-making; communicable disease diagnosis; cost; data acquisition; design; diagnostic assay; improved; indium arsenide; instrument; interest; melting; metal oxide; novel; nucleic acid detection; outcome forecast; performance tests; point of care; product development; prototype; public health relevance; research study

 DESCRIPTION (provided by applicant): Phase II project, submitted by InSilixa, Inc., a Silicon Valley start-up company, proposes to leverage Phase I accomplishments by developing a complementary metal-oxide- semiconductor (CMOS) biochip platform for the diagnosis of infectious diseases. This project addresses the growing global threat of antibiotic resistant bacteria whose emergence and dissemination now complicates antibiotic selection decisions, negatively affects prognosis, increases health care costs, and fuels increasing levels of resistance. To tackle this crisis, InSilixa will develop a highly multiplex platform that can simultaneously, rapidly and inexpensively detect an infectious agent in a clinical sample and identify the mutations that confer drug resistance. Specifically, the work proposed in this application will entail the design, implementation, and experimental validation of a nucleic acid amplification testing (NAAT) method that uses the proprietary HYDRA CMOS biochip detection platform. Aim 1 will develop a single-chamber, closed-tube, and highly multiplexed NAAT technology that quantifies, in real- time and in parallel, 10's of multiplex PCR reactions and identifies and characterizes the sequences of the generated amplicons by performing 100's of high-resolution melt curve analysis (MCA) experiments. Aim 2 will further develop the CMOS biochip detection platform (HYDRA-4K). And Aim 3 will develop a comprehensive NAAT assay based on combining the above technologies for detecting antimicrobial-resistance in M. tuberculosis. Though the initial clinical focus is tuberculosis, the design, development and manufacturing know-how gained during the course of this project will enable all other applications (and products) for the HYDRA platform. Included amongst these are attractive commercial opportunities including respiratory tract infections, drug resistant hospital acquired infections, outpatient urinary tract and pharyngeal infections and the identification, quantificatin and drug susceptibility genotyping of HIV in the blood of HIV/AIDS patients. The successful completion of this Phase II project will result in a fully characterized, working prototype of the InSilixa CMOS biochip platform that can simultaneously identify an infectious agent and the mutations that confer resistance to a large panel of antibiotics.

 描述（由申请人提供）：II期项目，由InSilixa，Inc.提交，硅谷的一家初创公司，提出利用第一阶段的成果，开发一个互补的金属氧化物半导体（CMOS）生物芯片平台，用于诊断传染病。该项目解决了抗生素耐药细菌日益增长的全球威胁，这些细菌的出现和传播现在使抗生素选择决策复杂化，对预后产生负面影响，增加医疗保健成本，并加剧耐药性水平。为了解决这一危机，InSilixa将开发一个高度多重的平台，可以同时，快速和廉价地检测临床样本中的传染性病原体，并识别赋予耐药性的突变。具体而言，在本申请中提出的工作将需要设计，实施和实验验证的核酸扩增测试（NAAT）方法，使用专有的HYDRONIC CMOS生物芯片检测平台。目标1将开发一种单室、封闭管和高度多重NAAT技术，该技术可以真实的实时和并行地定量10个多重PCR反应，并通过进行100个高分辨率熔解曲线分析（MCA）实验来鉴定和表征所产生的扩增子的序列。目标二：进一步开发CMOS生物芯片检测平台HYDROX-4K。目标3将在上述技术的基础上建立一种综合的NAAT检测方法，用于检测M.结核虽然最初的临床重点是结核病，但在该项目过程中获得的设计、开发和制造专业知识将使HYDRONIC平台的所有其他应用（和产品）成为可能。其中包括有吸引力的商业机会，包括呼吸道感染，耐药医院获得性感染，门诊泌尿道和咽部感染和艾滋病毒/艾滋病患者血液中艾滋病毒的鉴定，定量和药物敏感性基因分型。该二期项目的成功完成将导致InSilixa CMOS生物芯片平台的一个完全特征化的工作原型，该平台可以同时识别传染性病原体和赋予对大量抗生素耐药性的突变。