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JULY 8th, 2005
As the lead partner of a regional consortium, the University of
Washington was awarded a $15.4 million grant to develop an advanced, portable medical diagnostic system that can be used to
quickly diagnose diseases anywhere a health worker can walk to. From the list of companies involved in the project, which
includes Nanogen, the silicon microarray company, Micronics, the lab-on-a-card company, and PATH, a non-profit health strategy
company, the road points to a device that combines the latest miniaturized microfluidic analysis and sampling technology with
the latest genetic clinical analysis technology.
Commenting on the group was Paul Yager, lead investigator on
the project and Vice Chair and Professor at the University of Washington’s Department of Bioengineering, "This is a
formidable group. Each partner brings vital skills and experience to the mix. I believe this combination is what led to our
being selected from such a wide range of applicants and it's what will make our efforts successful.”
The award is one of 43 research projects that have been funded through
the $436 million Grand Challenges in Global Health initiative. The initiative is specifically focused to improve health care
and provide treatment for the diseases of the poor, the majority of diseases. That market is considered under served because
of market dynamics and differences in cost of living in different geographic areas.
The target size for the final working system is expected to fit
in a pocket, or about the size of a handheld computer.
JUNE 21st, 2005
Considered the world’s largest microarray and microtechnology
conference, Chips to Hits, has been scheduled to be held at the Boston Convention and Expo Center from September 12th to September
15th. The Chips to Hit conference, which focuses on the intersection of semiconductor technology and medical technology, that
is microfluidic, micromechanical, microoptical and microelectrical technology has over 100 exhibitors that have technology
related to both fields.
STMicroelectronics, which has been involved with micromachine technology for several
years will be in attendance along with two other MEMs vendors, SiMEMS Pte Ltd. and TECAN. Nanogen, one of the first companies
that integrates the silicon world with miniaturized lab technology will also be there. Big names in the DNA microarray world
will also exhibit. These include Affymetrix, Applied Biosystems, GE Healthcare and Roche. IBM Corporation is also on the list
of exhibitors.
The conference is to be held as part of the 4th Annual Molecular
Diagnostics and Personalized Medicine conference.
JUNE 20th, 2005
SuperArray Bioscience has begun its program for the provision of affordable
custom designed genetic microarrays. The microarrays permit researcher to select the specific genetic content of the microarrays.
Besides the selection of microarrays from SuperArray's catalog, researchers will be now be able to choose from a much broader
set. According to David Martz, Director of Marketing and Sales at SuperArray, "researchers are really the ones who know which
genes are most important for their specific research project. Their gene lists may come from their own literature reviews,
or may be discovered through their own microarray-based surveys of the whole genome. This custom microarray service provides
them with the affordable flexibility they need to make the ideal focused microarray for their initial experiments or larger
screening and validation projects."
SuperArray noted that their GEArray system can be used with as little
as or less than 100 ng (nanograms) of total RNA. Mr. Martz went on to comment about the easy to use procedure and low cost,
"The method is very easy to perform and doesn't need any special or dedicated equipment. The low price also allows it to be
used routinely in any biological laboratory setting. With their flexibility, ease-of-use and low cost, these custom arrays
should be well-suited for a very wide range of laboratories interested in microarray experiments."
JUNE 17th, 2005
Following a trend, Moore's Law, which has guided semiconductor advances
over the last 40 years, Affymetrix Inc. (NASDAQ:AFFX) reports that its new GeneChip Scanner (GCS) 3000 7G is able to scan
microarrays with feature sizes which range from 2.5 micron to 0.51 micron. The ability to scan such small features gives the
scanner the ability to analyze 500 percent more data than past generations.
Chip Leveille, Vice President of Product Technologies Group at Affymetrix
summarized the achievement, "The GeneChip Scanner 3000 7G combines advanced design improvements with high-resolution scanning
to dramatically improve efficiency in genetic analysis for gene expression and DNA analysis applications. We designed the
original GCS 3000 to be forward-compatible, requiring only a simple upgrade to support the next-generation of high-density
microarrays that develop as GeneChip technology continues to advance."
In comparison, today's most advanced digital semiconductors are
built with process technologies with feature lengths in the order of 0.09 microns, about five times smaller than the feature
length of the current biochips.
JUNE 3rd, 2005
Affymetrix Inc. (NASDAQ:AFFX) has agreed to acquire ParAllele BioScience
Inc. for about $120 million in a stock based transaction. In announcing the news of the acquisition, Affymetrix emphasized
ParAllele's proprietary Molecular Inversion Probe (MIP) assay. The MIP permits tens of thousands of reactions to be multiplexed
in just one tube. The technology, noted for its ability to enable scientists to conduct, unimpeded, any type of genetic experiment,
was used in the International Human Haplotype Mapping (HapMap) Project. As an invaluable tool for researchers, the combination
of ParAllele's assay and Affymetrix's GeneChip technology serve as a different type of "molecular microscope."
Stephen P.A. Fodor, Ph.D., Founder, Chairman and Chief Executive
Officer of Affymetrix emphasized the scope of the technology merger, "Together, Affymetrix and ParAllele have enabled new
areas of science by offering products to explore the whole genome, as well as specific regions of interest. The potential
for ParAllele's technology goes far beyond genotyping. We will combine both companies' technologies to accelerate discovery
and product development in a wide variety of areas, from basic research to the clinic."
JUNE 3rd, 2005
Jivan Biologics Launches Splice Variant Microarray - Multiplies
Biomarkers
Jivan Biologics, Inc. announced commercial genome-wide microarrays for alternate splicing, the
genetic encoding of multiple RNA and proteins . Subha Srinivasan, PhD, CEO of Jivan Biologics commented briefly on the
implications of the technology and market size, "TransExpress Whole Spliceome places Jivan at the forefront of a paradigm
shift from gene arrays to splice variant arrays that will transform the half-billion-dollar-a-year microarray market." The
new arrays, to be manufactured by Agilent Technologies - a world leader in the DNA microarray market, are used to detect changes
in RNA splicing throughout the human genome. The TransExpress Whole Spliceome has "148,693 probes for 135,706 alternately
spliced sites for 98,382 splice isoforms of 23,484 human genes." The arrays are said to increase the number of clinical
biomarkers and molecular diagnostics four fold over other commercially available DNA arrays.
Concurrent with the announcement, Jivan Biologics introduced TransExpress
Whole Blood. Dr. Srinivasen also commented on the market implications for that product, "The quest for clinically relevant
biomarkers already constitutes a large portion of the half-billion-dollar-a-year microarray market. By detecting RNA splicing
events in patient samples, TransExpress Whole Blood places Jivan at the forefront of a market shift from gene arrays to splice
arrays that can detect four or more times the number of potential biomarkers and molecular diagnostics as a conventional gene
array." According to the company TransExpress Whole Blood has "31,765 probes for 30,042 alternately spliced sites for 19,770
splice isoforms of 2,928 human genes expressed in whole blood."
Finally, with the announcement of the company's TransExpress Gene
Family of splice variant arrays, the company indicates that it has a complete line of splice variant microarrays for every
stage of drug development.
MAY 18th, 2005
Epigenomics AG (Frankfurt, Prime Standard: ECX) reports that its
proprietary DNA methylation markers are to be used in a test to determine the response of patients to chemotherapy. The marker,
used in the test, PITX2, is expected to eliminate chemotherapy as therapy for about 50 percent of breast cancer patients.
The company indicates that many patients can avoid the often very unpleasant experience of chemotherapy with just endocrine
therapy.
Alexander Olek Ph.D., Chief Executive Officer of Epigenomics commented
on data from a study presented at the American Society of Clinical Oncology and its own studies, "The results of these studies
are a major step forward for the team at Epigenomics and our clinical collaborators. Together with our previous studies, we
have now confirmed the strong correlation of PITX2 with disease recurrence in over 1000 breast patients from four different
studies. Due to the excellent clinical performance in all studies we have conducted so far and the fact that the marker can
be reliably measured in paraffin-embedded tissue, we are confident that our tissue-based tests incorporating these and other
specific DNA methylation markers will become a very valuable tools for oncologists to help them guide adjuvant therapy with
tamoxifen and potentially other endocrine based therapies, and/or chemotherapy in breast cancer."
Epigenomics also pointed to a study in the journal Cancer Research.
In that study, the company states "DNA methylation markers are also strong outcome predictors in patients treated with tamoxifen
for advanced disease." In that study microarray based technology was used " to determine the DNA methylation status of 117
candidate genes in a cohort of 200 steroid hormone receptor-positive tumors of patients who received tamoxifen as first-line
treatment for recurrent breast cancer."
MAY 12th, 2005
DNA Semiconductor Sensor Tests DNA Samples in Minutes
Asia Pulse Ltd. reports
that Horiba Ltd. (TSE:6856), a subsidiary of Horiba Biotechnology Co. has developed a DNA chip that can test DNA samples in
minutes and without the need to amplify the DNA. Central to the technology is a semiconductor based sensor coated with DNA
fragments. The DNA fragments are selected to bind with a target gene within sample fluid. If the target gene is present, the
target gene will bind with the DNA fragments on the sensor and change the electric potential of the sensor. The work was done
in conjunction with Toyama University. The chip as reported by A-TIP, which translated the original report from the
Nikkei Business Daily, is over 10,000 times more sensitive than conventional DNA chips.
MAY 11th, 2005
Tm Bioscience Corporation (TSX: TMC) has announced that its Tag-It
Cystic Fibrosis Kit, a DNA test used to determine if newborns and children are inflicted with mutations and variants of cystic
fibrosis transmembrane conductance regulator (CFTR) gene, has been given clearance by the U.S. Food and Drug Administration
for diagnostic use in the United States. The Tag-It Cystic Fibrosis Kit tests for 23 CFTR gene mutations and 4 variants (polymorphisms).
The company also indicated that the test could be used to determine if the genetic makeup of potential parents would result
in offspring with cystic fibrosis. The test is reported to be 100 percent accurate and have greater than 99.9 percent reproducibility
and precision.
Greg Hines, President and CEO of Tm Bioscience indicated that the
clearance put the company in a good position relative to its competitors, "This clearance establishes Tm as a unique supplier
of CF tests to our rapidly expanding customer base against such competitors as ABI (NYSE:ABI). The Tag-It(TM) Cystic Fibrosis
Kit is the only CF testing system that has performance characteristics which have been established through extensive studies
reviewed by the FDA. Having the first CF test and second multiplexed genetic test behind Roche's (RHHBF.PK) AmpliChip CYP450
to be cleared as an IVD (in vitro device), sets the regulatory pathway for other tests in our broad and growing pipeline and
positions Tm as a leader in the commercial genetic testing market."
Dr. Michael Watson, Executive Director, American College of Medical
Genetics also signaled that the product would be well received, "Clearance by the FDA of a genetic assay for cystic fibrosis
provides a highly standardized product for laboratories that offers tremendous benefits to the genetic testing industry, physicians
and to patients."
Tm Bioscience, with the announcement, gave statistics about the
disease. In the Caucasian population, the incidence rate is approximately 1 in 3,200 live births.
APRIL 29th, 2005
Affymetrix, Inc., (NASDAQ:AFFX), with a report that its latest quarterly
revenue reached $88.6 million, broke down its first quarter product sales as follows: $47.7 million in GeneChip sales (DNA
Arrays), reagent revenue of $9.9 million, and instrument revenue of $15.9 million. Affymetrix also shipped some 50 GeneChip
Systems in the quarter. Shipments of those systems now total over 1,225. Total product and product related revenue was $84.
9 million in the quarter ended March 31, 2005 compared to total product and product related revenue of $74.6 million for the
same quarter last year.
MARCH 30th, 2005
Reports indicate that Canon, Inc., a company that is actively involved
in a number of technology areas, has in development a system for the mass production of DNA chips. The technology is based
on ink-jet technology used in printers. The entrance of printer companies into the biochip market is no surprise. Hewlett-Packard
bases its ink-jet printer technology on electronically controlled microfluidic devices. Hewlett-Packard has also been actively
developing its ink -printer MEMS technology for areas besides printers.
MARCH 17th, 2005
California's stem cell initiative, Proposition 71, guaranteed $3 billion
in funds for stem cell research. The University of California at Los Angeles (UCLA) is one of the first beneficiaries. UCLA
has now announced the formation of the Institute for Stem Cell Biology and Medicine. The Institute is to be funded with $20
million over the next five years.
The Institute for Stem Cell Biology and Medicine brings together the
resources of the David Geffen School of Medicine, UCLA's Jonsson Cancer Center, the Henry Samueli School of Engineering and
Applied Science, and the UCLA College. These three operations will bring together their respective knowledge of integrated
microfluidics, microarrays, mass spectroscopy based proteomics and bioinformatics computational expertise and facilities for
the development of stem cell related therapies.
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