News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

Two Biotech Firms Pull Ahead in Race for $1,000 Human Genome Sequence

If you believe the press releases, the race to be first to achieve the $1,000 full human genome sequence is narrowing down to two primary contenders. One is Complete Genomics, Inc. of Mountain View, California, and the other is Pacific Biosciences (PacBio).

Last fall, Complete Genomics, Inc. was profiled in The Dark Report. It has ambitiously declared that, by this spring, it will be ready to roll out a global commercial DNA sequencing service. The company intends to offer pharmaceutical firms and researchers genetic sequences for $5,000 each, but predicts the cost could eventually come down to as low as $100! (See “Rapid Genome Sequencing Predicted by Mid-2009, The Dark Report, October 20, 2008)

The other contender believes it can tap the immediate consumer market for genomic profiles. Pacific Biosciences, a Menlo Park, California biotechnology firm, vows to offer a personal genome profile in 15 minutes for under $1,000 by 2010.  The company predicts the cost could drop to a mere few hundred dollars.

Experts have long predicted that “less than $1,000” is the price point required for advancing the use of whole human genome analysis in patient care. Currently it takes about six weeks and costs $100,000 or more to sequence the entire DNA of a single human.

Both companies are leveraging novel technology platforms to reduce time and cost of full sequencing of an individual human genome. Complete Genomics’ proprietary sequencing technology, a combination of biochemistry and nanotechnology, uses much lower volumes and concentrations of reagents than existing sequencing systems. That supports higher throughput and reduces materials costs to $1,000 per sequence.

PacBio, on the other hand, has developed innovative Single Molecule, Real-Time (SMRT) DNA technology that uses a small chip with tiny observation wells, called Zero-mode waveguides (ZMWs). The chip separates the DNA and deposits it into ZMWs, where a DNA polymerase molecule duplicates the DNA strands. The SMRT DNA machine captures the process as it occurs while reading longer fragments of DNA sequence. According to PacBio, this produces a faster, more complete read of the original DNA sequence.

Inexpensive whole human genome sequencing will trigger a rapid series of advances in genetic knowledge and new clinical services. Assuming that software systems can stay up with the billions of data points generated by a single human genome, then researchers will be able to search for how hundreds and thousands of genes may be implicated in different diseases and health conditions. In turn, that knowledge will be used to create new diagnostic tests, thus opening up a new field in laboratory medicine.

Next week, at the Molecular Summit in In Vivo and In Vitro Integration, this topic will be discussed. Experts in the molecular biomarker field, such as George Poste, DVM, Ph.D., Chief Scientist at the Biodesign Institute of Arizona State University, will be addressing personalized medicine, companion diagnostics, and the role that whole human genome sequencing will play in transforming healthcare. You can register and attend this exceptional conference by visiting this site: http://www.molecular-summit.com The full agenda and speaker line-up for Molecular Summit 2009 on February 10-11 can be viewed here (or paste this URL into your browser: http://www.molecular-summit.com/program.htm)

Related Information:

Four Easy Ways to Register for Molecular Summit 2009:

1. Register ONLINE
2. Call 800-560-6363. Our friendly staff can register you quickly and easily, as well as answer any questions you may have.
3. Fax this complete registration form to 512-264-0969
4. Mail the one page register form with payment to:

THE DARK REPORT
21806 Briarcliff Dr.
Spicewood, TX 78669

World Congress of Pathology in Sydney Recognizes Globalization of Pathology

Pathology is on a path to globalization and evidence of this ongoing trend will be seen on March 13-15, 2009 at the XXV World Congress of Pathology and Laboratory Medicine in Sydney, Australia. For starters, several thousand pathologists from nations around the world will gather to hear 120 different sessions and visit an international hall of exhibitors. That’s an impressive demonstration of how laboratory medicine is crossing borders.

But what Dark Daily subscribers and readers may consider a fascinating sign of pathology globalization at the World Congress of Pathology is this year’s addition of a special extended session titled “Laboratory Medicine’s Transformational Role in the Genomic Age.” The goal is to predict the path of pathology as genetic knowledge unlocks new diagnostic capabilities, which give pathologists new tools to diagnose disease and identify the most promising therapies for patients. Batting first in this line-up is your intrepid Dark Daily Editor. Here’s the international panel for this session:

Why Pathology Testing Is Soon to Cross New Clinical Boundaries

Mr. Robert Michel, Editor, The Dark Report and Dark Daily, Spicewood, Texas, USA

Translation of Genetic Information into Healthcare Use

Dr. Michael Watson, Executive Director of the American College of Medical Genetics and Adjunct Professor of Pediatrics, Washington University, St. Louis, Missouri, USA

Genetics Practice and Research in a Small Country: Lessons from Iceland

Dr. Jón J Jónsson, Chair of the Division of Biochemistry, Clinical Biochemistry and Medical Genetics, Landspitali-University Hospital, Reykjavik, Iceland

In Vitro-In Vivo Diagnostic Frontiers

Dr. Don Rucker, Vice President and Chief Medical Officer of Siemens Medical Solutions USA, Malvern, Pennsylvania USA

The Future of Pathology

Dr Jared Schwartz, President, College of American Pathologists, Director of Pathology and Laboratory Medicine at Presbyterian Healthcare, Charlotte, North Carolina, USA

This year’s World Congress of Pathology is organized by the Royal College of Pathologists of Australasia (RCPA). The Aussie hosts remind us that-despite globalization- all healthcare is local by offering a series of presentations on the types of forensic pathology cases frequently in Australia, titled: “Recreational Deaths”

Ultra-light Plane Crashes

Dr. Jo Duflu

Scuba Diving Fatalities

Dr. Chris Lawrence

Australian Outback Deaths: Snakes, Sun, and Crocodiles

Dr. Kevin Lee

Certainly those topics are a reminder that some Australians enjoy activities that come with risk. The World Congress of Pathology, with its 120 sessions, will have something for everyone. The full agenda and registration information can be accessed by visiting the RCPA Web site http://www.rcpa.edu.au/Continuing/PathologyUpdate.htm (Or paste this URL in your browser: http://www.rcpa.edu.au/Continuing/PathologyUpdate.htm).

The day before the World Congress of Pathology Convenes, a special full-day seminar on the business and management of pathology laboratories will take place, co-produced by the Australasian Association of Clinical Biochemists (AACB) and the RCPA. On March Titled: “The Pathology Workforce Crisis: International Situation & Solutions.” Robert Michel, your Dark Daily Editor, will be the opening speaker. Full details for this program can be accessed at the AACB (Or paste this URL in your browser: http://www.aacb.asn.au/).

Related Information:

Multi-Modality Diagnostics Is Goal of Innovative Health Informaticians

Off the radar screen of most pathologists and radiologists is an effort by health informaticians to create new diagnostic tools that use the latest computer technology. What distinguishes these current development programs from those of earlier years is that today’s software is capable of incorporating digital images with other types of clinical information.

This research field opens a path to multi-modality diagnosis that is not rooted exclusively in pathology or radiology settings. To the contrary, these are IT wonks working independently. They want to create a software program capable of making an accurate diagnosis. Their software engines are designed to use a wide variety of clinical data.

Among these innovators is Badri Roysam, Ph.D., Professor, Department of Electrical Computer & Systems Engineering at Rensselaer Polytechnic Institute in Troy, New York. Roysam, whose doctorate is in electrical engineering, is actively crossing traditional scientific boundaries. “My lab develops multi-dimensional image analysis algorithms in service of applications in biology and medicine,” says Roysam. “We collaborate with a long and growing list of colleagues in diverse disciplines. Our work is supported by federal agencies (e.g., NSF, NIH, U.S. Army), private foundations (e.g., Cure Huntington’s Disease Initiative) and companies (e.g., Siemens, MBF Biosciences, Pfizer) for which we are thankful.

“The world of biology is on the move,” continues Roysam. “Biological investigations are shifting:

1)  from qualitative and observational towards quantitative;

2)  from reductionist approaches towards the study of integrated systems consisting of multiple interacting components;

3)  from sequential experimentation towards high-throughput and high-content studies; and,

4)  from static observations of fixed tissue towards dynamic observations of living tissue.”

Roysam points out that the field of clinical diagnostics will be transformed by a wide range of new technologies that threaten to overload pathologists, radiologists, and the attending physician with cascades of data. Microarrays now produce tens of thousands of data points for just one patient’s assay. Full gene analysis by DNA sequencing is available and those tests produce millions of data bits-and that’s before the expected arrival of the $1,000 whole human genome sequence as an affordable clinical service!

You can meet and hear Roysam at the upcoming Molecular Summit on the Integration of In Vivo and In Vitro Diagnostics in Philadelphia on February 10-11, 2009. Location is the Sheraton Society Hill Hotel in Philadelphia, Pennsylvania.

Another innovator in diagnostic informatics is Anant Madabhushi, Ph.D., Assistant Professor, Director, Laboratory for Computational Image & Bioinfomatics (LCIB), The State University of New Jersey, Rutgers, Piscataway, New Jersey. Madabhushi’s presentation is titled: “Diagnosing Prostate Cancer and Breast Cancer with Multiple Modalities, Including Image, Spectral Analysis, Histopathology, and Gene Analysis.”

For pathologists and radiologists interested in how these modalities are being pulled together to aid diagnosis, attending Molecular Summit 2009 is a fast-track way to learn the latest and craft a winning strategy for your own laboratory or radiology practice.

Along with Roysam and Madabhushi are 25 other pathologists, radiologists and informaticians who are leading the charge to integrated molecular imaging and molecular diagnostics. Attendees will see, hear, and learn from the sharpest minds in this rapidly-evolving field.

Act now and register so you can be with us at this remarkable event. You can register for Molecular Summit by visiting this site:

The full agenda and speaker line-up for Molecular Summit 2009 on February 10-11 can be viewed here (or paste this URL into your browser: http://www.molecular-summit.com/program.htm )

Visit http://www.molecular-summit.com

Download Full Program Brochure (pdf)

Four Easy Ways to Register:

1. Register ONLINE
2. Call 800-560-6363. Our friendly staff can register you quickly and easily, as well as answer any questions you may have.
3. Fax this complete registration form to 512-264-0969
4. Mail the one page register form with payment to:

THE DARK REPORT
21806 Briarcliff Dr.
Spicewood, TX 78669

Joint Commission Goes International with Healthcare Quality Standards

As part of its plan to stake out a place in the international market for healthcare quality standards, Joint Commission International (JCI), the international arm of The Joint Commission (JC), in partnership with the World Health Organization (WHO), launched a new global program to improve patient care and safety worldwide.

JCI’s first demonstration project involves financially strapped, low-performing hospitals in Mexico, China and Palestine, according to JCI Chief Medical Officer David Jaimovich. In an interview with Modern Healthcare, he suggests that the demonstration project allows JCI to measure the program’s capabilities under the worst conditions.

The program, “Essentials of Health Care Quality and Patient Safety”, focuses on five high-risk areas known to have the greatest impact on quality and safety. It provides a way to evaluate progress and defines the levels of effort for each criterion. The five areas include:

1) leadership process

2) accountability,

3) competent and capable workforce,

4) safe environment for staff and patients, and,

5) clinical care of patients.

In an interview with Modern Healthcare, Asian healthcare expert Tsung-Mei Cheng, editor of Princeton’s International Forum, says China is committed to updating and upgrading its hospitals, so international benchmarking should be “enormously helpful.”

In Mexico, President Felipe Calderón emphasizes improvements to healthcare as way to maintain the healthy workforce required to sustain the strong economy vital to keeping the nation’s skilled workforce at home. Mexico’s status as a trade partner, neighbor and destination for Americans traveling and living abroad makes the United States a stakeholder in ensuring healthcare quality and safety in Mexico.

In fact, the increased migration of Americans, Canadians, and Europeans to Mexico is an important factor in Mexico’s efforts to upgrade its healthcare system to U.S. standards. Physicians in Mexico, many of whom were educated in U.S. medical schools are forming physicians groups and establishing American-style medical testing and diagnostic services. Some of these physicians have a goal and a hope that they can negotiate contracts with Medicare and other U.S insurers to provide services to U.S. citizens living in Mexico.

The push for international healthcare quality standards will continue to be a priority in a global economy. Foreign markets attractive to aging Baby Boomers, however, also provide tremendous opportunities for healthcare service providers. So it is no surprise that the Joint Commission wants to play an increased role in helping establish and maintain health quality and accreditation standards in many countries across the globe.

Related Information:

Regional Laboratory Networks Sprouting in the United Kingdom

BIRMINGHAM, ENGLAND – Here in the United Kingdom, regional laboratory networks are finally catching on. The number of “pathology networks,” as they are called here, has increased in recent years. As was true of Canada in the late 1980s and the United States and Australia during the 1990s, clinical lab leaders in the United Kingdom are finding regional laboratory networks to be effective business models to achieve tight integration of lab services, realize significant cost savings, and eliminate excess lab testing capacity in regional markets.

These achievements were confirmed by presentations delivered yesterday in Birmingham, England, at the sixth annual Frontiers in Laboratory Medicine (FiLM) conference yesterday. Produced jointly by the Association of Clinical Biochemistry and The Dark Report. Your editor, Robert Michel, is here and participating in all the sessions. Four regional laboratory networks presented their accomplishments yesterday.

In the northwest of England, the Greater Manchester Pathology Network, formed in 2005, is composed of laboratories from 16 hospitals and serves a population of 2.5 million people. In his presentation, co-presenters Neil Jenkinson, Ph.D., Network Director, and Keith Hyde, Ph.D., Deputy Director of Laboratory Medicine, reported how participating pathology laboratories (as clinical laboratories are called in this country) are progressively developing integrated lab testing services. One key objective is to develop a common laboratory informatics capability that allows the 16 hospital laboratories to more effectively serve primary care clinics in the region.

Local to the Birmingham area, Coventry and Warwickshire Pathology Services was created in May 2007, by two acute care trusts that had always been wary of each other, According to Neil Anderson, Ph.D., Director, this pathology network has 412 employees and provides lab testing services to a population of 950,000. Steps toward integration and consolidation of lab testing services centered around three areas of lab testing:

  • Blood sciences (Chemistry, Hematology, Transfusion medicine and Immunology)
  • Microbiology (Microbiology, Virology, and Laboratory Infection Control)
  • Cellular Pathology (Histopathology, Cytology and Mortuary services).

Anderson explained that, within two years, the pathology network had delivered £1.9 million (U.S.$2.8 million) in savings to its two parent trusts. As well, steps had been taken to install a common laboratory information system (LIS), and flexibility in staffing was contributing to improved levels of service to clinicians.

Two overseas regional laboratory networks were at FiLM to share their successes learned. In Australia, Sullivan Nicolaides Pathology Laboratories, a division of Sonic Healthcare, LTD, operates a regional laboratory network in Northeastern Australia that serves a population of 3 million people. With a central laboratory in Brisbane, it has 21 other laboratories located across a service area of millions of square miles in the states of Northern Territory, Queensland, and New South Wales. Executive Manager Tony Badrick, Ph.D., observed that, with an operating history of several decades, this regional laboratory network’s current objective is to quality management systems to advance the performance of operations. Sullivan Nicolaides is certified under ISO 9001 and ISO 15189. It is working on its ISO 14000 certification.

The fourth regional laboratory network presented at FiLM Tuesday was Calgary Laboratory Services in Calgary, Alberta, Canada. This case study was presented by Fred Swaine, M.D., Chief Operating Officer. This regional laboratory network was created back in the mid-1990s, when the government of Alberta mandated an immediate reduction of 35% in funding for laboratory services. Swaine described how this regional laboratory network is in the midst of its third cycle of lab consolidation and integration since 1996. It serves 1.2 million people and is currently comprised of one central laboratory, with rapid response labs in four hospitals.

Swaine noted that one notable accomplishment of the early network organization was to install a single laboratory information system (LIS). That has made it easier for Calgary Laboratory Services to collect, store, and provide access to laboratory data across its entire service region.

Dark Daily notes that these four examples of regional laboratory networks demonstrate how this trend has established strong roots. For almost two decades, operational regional lab networks in Australia, Canada, and the United States have proved to be effective providers in their respective service areas. It is expected that the number of pathology networks will continue to expand.

Related Information:

;