比如前两天我在Illumina做介绍,因为他们说对iCubate和iRepertoire两 个公司都感兴趣,所以我从新组织了一下幻灯片,加在一起有95张之多,可是会议结束后得到的一个评论“Very impressive presentation, did not feel you had so many slides at all", 因为我的幻灯片里面绝大多数都是图片和提醒我要讲的内容的几个关键词,没有很“忙”的,充满文字的幻灯片。这样听众就不会觉得很累。
INFECTIOUS DISEASE HudsonAlpha is working to improve healthcare quality, while lowering healthcare costs.
FACT Pathogens (bacteria, viruses, and protozoans) must be accurately detected for proper diagnosis and treatment of infectious diseases.
WE KNOW Each pathogenic microorganism or virus has a unique DNA fingerprint.
The Polymerase Chain Reaction (PCR) can detect DNA from microorganisms or viruses with great sensitivity.
PCR assays for many pathogens may be combined together (multiplexed), so that only one clinical sample is needed to identify the actual pathogen from a broad spectrum of possibilities.
BACKGROUND For the USA alone, the cost of treatment and lost productivity associated with illness from infectious disease is more than $120 billion each year.
PROBLEM PCR multiplexing is easy in theory, but difficult in practice—especially in a clinical setting—so that few multiplex tests are available.
Existing PCR-based diagnostic tests require manual intervention and are therefore slow, costly, and sometimes unreliable because of operator error.
Diagnostic tests are currently performed in an open environment, with an unacceptable risk of sample contamination.
TASKS Develop more robust multiplex PCR assays. The proprietary ARM-PCR technology (Amplicon Rescued Multiplex PCR) allows up to 30 different DNA targets to be reliably amplified in one reaction.
Develop an automated and closed system for PCR diagnostic tests. The fully automated iCubate robotic system is fast (taking less than two hours from sample loading to diagnosis), inexpensive per test, and reliable. Samples are contained within a disposable, factory-sealed cassette, making sample contamination or cross-contamination virtually impossible.
The HudsonAlpha company iCubate is launching the iCubate system in 2010, which promises improved diagnosis for infectious diseases at lower cost.
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附件(2)给专家委员会看的简介:
One core technology, two key applications, and two commercial opportunities
Background
Dr. Jian Han invented a multiplex PCR method called amplicon rescued multiplex PCR (arm-PCR). The patent pending method allows hundreds of thousands of molecular targets to be amplified from one reaction, in a semi-quantitative fashion.
Dr. Han and his group have identified two major applications for the technology: (1) Molecular differential diagnosis of infectious diseases and cancers; and (2) Immune repertoire analysis by arm-PCR amplification followed by high throughput sequencing.
As a serial entrepreneur, Dr. Han formed two companies to fully capture the commercial opportunities: iCubate Inc., (www.iCubate.com) is a biotech company developing assays and instrument platforms for molecular differential diagnosis. iRepertoire Inc., (www.iRepertoire.com) is a company developing technology for high throughput sequencing of immune repertoires.
Updates
Molecular differential diagnosis.
Dr. Han raised $4.3 million from investors and obtained exclusive license of the arm-PCR to form iCubate. His team of scientists and engineers developed the prototype iCubate system that include a processor, a reader and software that control the instrument and providing an user interface.
The system can automatically perform DNA/RNA extraction, multiplex amplification and detection , and do so in a closed, disposable cassette. iCubate has already submitted a pre-IDE to FDA in order to prove their Staph-DR product. The product will allow rapid identification of Staph. including MRSA (methicillin-resistant Staphylococcus aureus), and also detecting many resistance genes, allowing physicians to optimize the treatment strategy. A pipeline of additional products for different infectious diseases are under development.
There are multiple patents filed to protect the technologies, including patent to protect the arm-PCR core technology and patents protect the cassette, the processor and the readers. Other IP include copy rights for the software and logo etc., as well as patents for sample preparations.
iCubate is raising $10 million USD for scale up manufacture of the instrument, and conducting clinical trails for FDA approval. Since the depute of the platform last Nov at the AMP meeting (molecular pathology), all major diagnostic companies (such as Abbott, Roche, Norvartis, and bioMerieux etc) had already contacted iCubate and invited Dr. Han to present the technology to high level executives.
Immune repertoire sequencing.
The first paper describing the use of arm-PCR/NextGen sequencing approach was published on PNAS earlier this year:
Wang C, Sanders CM, Yang Q, Schroeder HW Jr. Wang E, Babrzadeh F, Gharizadeh B, Myers RM, Hudson JR Jr. Davis RW, Han J. High throughput sequencing reveals a complex pattern of dynamic interrelationships among human T cells subsets. PNAS 2010 Jan 26; 107(4):1518-23.
A company, iRepertoire Inc., was formed to explore the commercial opportunity of this technology. Based on the method describe in the PNAS paper, a line of products and services were developed that allow scientists worldwide to have access to the technology. Human and mouse T and B cells can be used, sorted or not, for VDJ amplifications and sequenced with either Roche 454 or Illumina Solexa platforms. Barcoded primers allow upto 20 samples pooled for one sequencing run. A sequence known library is also available for aiding technology development and validation.
Several patents were filed protecting immune repertoire amplification and data analysis. Also, a patent is filled to protect a unique way to amplify B cell VDJs that overcome the impact of hypermutations.
Dr. Han’s group have already studied the immune repertoire of many samples, including samples from 10 breast cancer patients, 10 colon cancer patients, 10 lung cancer patients, 20 CLL patients, and 10 lupus patients. These studies will help identify signature immune repertoire changes that could be used as biomarkers for future studies. In addition, we have completed an extensive study post vaccine repertoire changes in two volunteers. More high quality publications are expected within this year.