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",
HudsonAlpha is working to improve healthcare quality, while
lowering healthcare costs.
Pathogens (bacteria, viruses, and protozoans) must be
accurately detected for proper diagnosis and treatment of infectious
Each pathogenic microorganism or virus has a unique DNA
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.
For the USA alone, the cost of treatment and lost productivity
associated with illness from infectious disease is more than $120 billion each
PCR multiplexing is easy in theory, but difficult in
practice—especially in a clinical setting—so that few multiplex tests are
Existing PCR-based diagnostic tests require manual
intervention and are therefore slow, costly, and sometimes unreliable because of
Diagnostic tests are currently performed in an open
environment, with an unacceptable risk of sample contamination.
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
Develop an automated and closed system for PCR diagnostic
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
The HudsonAlpha company iCubate is launching the iCubate
system in 2010, which promises improved diagnosis for infectious diseases at
One core technology, two key applications, and two commercial
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
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
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
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
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
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.