High School Student Develops Diagnostic Test to Detect Early-Stage Pancreatic Cancer

High School Student Develops Diagnostic Test to Detect Early-Stage Pancreatic Cancer
July 6, 2012 – Source : http://www.darkdaily.com

New approach to clinical laboratory testing could eliminate the need for tissue biopsies to diagnose different types of cancer

In Maryland, a 15-year-old high school freshman developed a diagnostic assay that experts say can be developed into medical laboratory test for the detection of pancreatic cancer. The teen’s prize-winning breakthrough test could change how cancer and other fatal diseases are diagnosed and treated.

More to the point for anatomic pathologists, this new approach to detecting pancreatic cancer is non-invasive, so it does not require a biopsy specimen. It is also inexpensive and fast. At a cost of about $3 per test, the diagnostic assay produces a result in five minutes.

Clever Diagnostic Test Could Find Use in Clinical Laboratories

A story published by Forbes.com described how teenager Jack Andraka took top honors—and a $75,000 award—at the Intel International Science and Engineering Fair for his stunning discovery of a new diagnostic test for early detection of pancreatic cancer.

“Survival rates for patients with pancreatic cancer remain low,” stated Michael Bouvet, M. D., Co-Director of the Gastrointestinal Cancer Unit at Moores Cancer Center at the University of California at San Diego (UCSD). He was quoted in a story sciencedaily.com reported by ScienceDaily.com.

Bouvet is a specialist in pancreatic surgery. He is involved with a UCSD research project to develop an early detection biomarker for pancreatic cancer. “[E]arlier detection and novel treatment strategies are very important if we are going to make any progress against pancreatic cancer,” he noted.

Andraka created a clinical laboratory test that uses filter paper dipped into a solution of carbon nanotubes (CN), Forbes reported. (See Dark Daily, “Carbon Nanotubes Hold Promise for Use in Speedy, Low-cost, Point-of-Care Medical Laboratory Tests”.) It detects the levels of mesothelin in blood or urine. Mesothelin is a protein biomarker for prostate cancer.

Click Here for Image Pictured here is 15-year-old Jack Andraka. He recently won top honors at the Intel International Science and Engineering Fair for his cleverly-designed medical laboratory test that can non-invasively detect pancreatic cancer. Andraka’s diagnostic test uses a paper filter and carbon nanotubes to detect protein markers associated with pancreatic cancer. (Photo by ShadesofSuccess.com)

Andraka was able to detect the small shifts in electrical conductivity that occurred after the proteins attached to the carbon nanotubes. Most interesting, his detection device was a $50 electric meter from Home Depot. The teen observed that this diagnostic test would also work with an ordinary diabetes meter.

By the time pancreatic cancer is detected using conventional medical laboratory testing methods, it is usually at an advanced stage, leaving patients with a poor prognosis. “It’s really crucial to detect [pancreatic, lung and ovarian cancers] in their early stages where survival rates are at their highest,” Andraka declared. “I focused specifically on pancreatic cancer… due to its extremely low survival rates.”

The motivation for Andraka’s research was personal. When Andraka’s uncle died of pancreatic cancer, the youngster became inspired to develop an early-detection test for the disease. “I became interested in early detection, did some research, and came up with this idea,” he stated.

Pancreatic cancer is the fourth leading cause of death in the United States. The National Cancer Institute estimates that, in 2012, over 43,000 new cases of pancreatic cancer are expected to be diagnosed and over 37,000 people will die from the disease.

New Approach Could Replace Existing Types of Medical Lab Testing

Andraka’s breakthrough test is non-invasive and built upon a paper strip test. Experts say its advantages over current assays for pancreatic cancer are striking. According to the Forbes story, Andraka’s test:

• is 100 times more selective than existing diagnostic tests;
• ignored healthy patient samples, as well as those with mere pancreatitis;
• is 168 times faster, 26,667 times less expensive, and 400 times more sensitive than the enzyme-linked immunosorbent assay(ELISA);
• costs $3, whereas an ELISA-based clinical laboratory test can cost up to $800;
• allows for ten tests to be performed on one strip;
• produces results in five minutes; and
• can be adapted for use to monitor resistance to antibiotics and to follow the progression of treatment of cancer patients undergoing chemotherapy or radiation.

Ironically, the ingenious Andraka was rejected by almost 200 researchers in his search for a lab to do his nanotube strip work, Forbes reported. Finally, Anirban Maitra, M.D., an instructor in the Division of Gastrointestinal Pathology at Johns Hopkins University School of Medicine agreed to let him work in his laboratory.

Clinical laboratory managers and pathologists will be interested to learn that Andraka is in the process of patenting his invention. According to Forbes, he plans to submit his work for publication through the American Association for Cancer Research.

Andraka said that he has been contacted by four companies, including Quest Diagnostics, Incorporated (NYSE: DGX), about potentially licensing or commercializing his idea.

—Pamela Scherer McLeod

Stem cells can be used to repair heart tissues without surgical incision: Experts

Stem cells can be used to repair heart tissues without surgical incision: Experts

March 31, 2012, 0800 IST

In a great sigh of relief to heart patients, top international researchers here in Hyderabad revealed that Stem Cell Technology can be used to repair damaged heart tissues without actually performing surgical incision into the chest.

While participating in the International stem cell conference at International School of Business at Gachibowli, scientists revealed that the stem cell technology can be used to repair heart tissues damaged by myocardial infraction commonly known as heart attack.

Taking it as a great break through in the medical sciences, doctors and heart surgeons felt that the stem cell technology will be a great boon to the millions of patients suffering from heart attacks.

According to eminent Scientist Prof. Minger, head global research and development at GE Healthcare UK, the heart tissues are usually damaged by the myocardial infraction. This is also commonly known as heart attack. By using the stem cell technology, it is easier and simpler to heal the heart tissues,” revealed the Scientist.

Usually in a conventional method of heart surgery doctors cut open the chest muscles to gain access to the heart, but now with the use of stem cell technology this practice can be put on halt.

By using the stem cell technology, the heart cells cultured in laboratory can be implanted in heart through a catheter from one of the arms. As this kind of treatment is not involving any physical incisions on the body, the patients can be discharged on the same day.

Further explaining in detail, Prof Minger said that heart attack occurs when blood supply to the heart is stopped for a long time and this damages the heart tissues. By using stem cell technology such damaged tissues can be treated without any complicated surgery.

The scientist advocated that as India is having a huge population of more than a billion, the country can play a key role in stem cells and regenerative medicine. “There is a need to create awareness among the population. If India and China could bank even one per cent of their annual births, they could supply stem cells to the whole world,” said Prof Minger.

“Public banking of cord blood will enable to treat many diseases which are incurable such as Parkinson’s and Alzheimer’s. In the next 4-5 years developing heart tissues damaged by myocardial infraction will become a real possibility,” revealed the scientist.

Throwing light on recent developments, the professor said that heart cells derived from  bone marrow have been implanted successfully in a patient, and the technology is helpful in transplanting new insulin-producing cells for diabetics and myelinating cells for individual afflicted with multiple sclerosis.

Economic Conditions Snapshot, June 2011: McKinsey Global Survey results

Economic Conditions Snapshot, June 2011: McKinsey Global Survey results

Executives’ expectations for their national economies have declined since March, but the outlook for their companies remains positive—especially in developed Asia.

Please log onto http://bit.ly/jGqAa8 for more information

ISO/TS 10674:2011, Rating services – Assessment of creditworthiness of non-listed entities

Source : http://www.iso.org

New ISO specification will increase transparency and reliability of credit assessments

Credit bureaus and their customers who seek to operate in an international market now have a valuable tool in a new ISO technical specification which offers a harmonized, more transparent and more reliable approach to assessing the creditworthiness of companies.

ISO/TS 10674:2011, Rating services – Assessment of creditworthiness of non-listed entities, provides common terms, definitions and basic process requirements for the assessment of creditworthiness (“Is the company worthy of having credit extended to it?”).

Extending credit to companies is a common component of business today. However, for small and medium-sized enterprises (SMEs) in particular, the decision to extend credit can involve numerous financial concerns. These concerns need to be answered beforehand to avoid a host of problems afterward – which begs the question:  “Is credit assessment reliable?”

In view of the increasing number of credit assessment service organizations, each with its individual assessment system, there is now a clear need for a common evaluation and communication tool – which is answered by the new ISO technical specification.

Dr. Olivier Everling, Chair of the project committee that developed ISO/TS 10674:2011, explains, “In the aftermath of the financial crisis, rating agencies and credit bureaus needed to simplify and provide broader market access to rating criteria, underlying models and analytical tools, to better organize information about their criteria, models and policies, and to offer access to additional analytical tools.

“ISO/TS 10674:2011 is a bi-product of the financial crisis intended to promote transparency and enable the market to best judge the performance of the assessments. It will be an invaluable tool for promoting international trade by making it possible to obtain more reliable credit assessments of even the smaller partners in global markets.”

ISO/TS 10674:2011, Rating services – Assessment of creditworthiness of non-listed entities, was prepared by ISO/PC 235, Rating services. It costs 66 Swiss francs and is available from ISO national member institutes and from ISO Central Secretariat through the ISO Store or by contacting the Marketing & Communication department

New ISO standard on phased implementation of environmental management systems will benefit SMEs

Source : www.iso.org

ISO has just published a new standard in order to help organizations, and in particular small- and medium-sized enterprises (SMEs) use a phased approach to implement an environmental management system (EMS).

Today, organizations increasingly take into account environmental management requirements in their activities. However, even if they clearly see the benefits they can derive, implementing an EMS is not always an easy task, especially for SMEs.

The job will now be made easier by ISO 14005:2010, Environmental management systems – Guidelines for the phased implementation of an environmental management system, including the use of environmental performance evaluation.

The purpose of this standard is to provide guidance for organizations on the phased development, implementation, maintenance and improvement of an environmental management system in order to meet the requirements of ISO 14001, which provides the requirements for an EMS. ISO 14005 also includes advice on the integration and use of environmental performance evaluation techniques.

This International Standard is applicable to any organization, regardless of its level of development, its activities, or its location.

A phased approach offers several advantages:

• Users can readily evaluate how the time and money put into an EMS provides a return
• They can see how environmental improvements help to reduce costs, improve their community relations, assist them in demonstrating compliance with legal and other requirements, and help them live up to customer expectations
• They can track the benefits of their EMS while they implement their system step by step, adding or expanding elements as they provide value to the organization
• They can focus on the issues that are critical for them, their customers or supply chain.

The model outlined in the standard has been developed to help an organization to implement an EMS in a flexible way focusing on the organization’s needs, while growing the extent and scope of the system, through time, in line with the objectives of the organization and the resources available.

Dr Anne-Marie Warris, Chair of the ISO subcommittee responsible for ISO 14005, comments: “The working group members that developed the standard are to be congratulated for their hard work in producing guidance related to this important area. During the project, a number of developing countries indicated the importance of this work for their communities.”

An EMS meeting the requirements of ISO 14001:2004 is a management tool enabling an organization of any size or type to:

• Identify and control the environmental impact of its activities, products or services
• Continually improve its environmental performance
• Implement a systematic approach to setting environmental objectives, to achieving these and to demonstrating that they have been achieved
• Ensure legal compliance.

Although accredited certification of conformity to ISO 14001 is not a requirement of ISO 14005 or of ISO 14001, many organizations choose to seek accredited certification as an independent confirmation that their EMS meets the requirements of ISO 14001. The ISO Survey of Certifications 2009 revealed that up to the end of December 2009, at least 223149 ISO 14001:2004 accredited certificates had been issued in 159 countries and economies.

ISO 14005:2010 was developed by ISO technical committee ISO/TC 207, Environmental management, subcommittee SC 1, Environmental management systems, and is available from ISO national member institutes . It may also be obtained directly from the ISO Central Secretariat, price 168 Swiss francs through the ISO Store or by contacting the Marketing, Communication & Information department.

New edition of ISO/IEC 17021 aims to raise level of management system certification

Dt : 2011-02-01  Source : www.iso.org

The just-published second edition of the International Standard ISO/IEC 17021 sets new requirements for the auditing of management systems and for auditor competence in order to increase the value of management system certification to public and private sector organizations worldwide.

The certification bodies that carry out management system certification (independently of ISO), are being given a two-year period to bring their operations in line with the new edition (see below).

ISO/IEC 17021:2011, Conformity assessment – Requirements for bodies providing audit and certification of management systems, is intended to increase trust in certificates issued attesting conformity to management system standards (MSS) such as ISO 9001 (quality management), ISO 14001 (environmental management) and ISO 22000 (food safety management). Certificates to these and other MSS are widely used in global markets to establish confidence between business partners and between organizations and their customers, to qualify suppliers in supply chains, and as a requirement to tender for procurement contracts.

The first edition, published in 2006, named six principles that inspire confidence: impartiality, competence, responsibility, openness, confidentiality, and complaint handling. These principles then formed the basis for specific requirements given in the standard.

The new edition retains these principles and requirements, but adds new requirements developed in response to market feedback on the use of the first edition. The new requirements provided in ISO/IEC 17021:2011 relate to the competence of the auditors who carry out certification and to the way in which they are managed and deployed.

Certification bodies that use the new edition will be able to ensure competent audit teams, with adequate resources, following a consistent process and reporting audit results in a consistent manner.

Observance of the standard’s requirements is intended to ensure that certification bodies operate competently, consistently and impartially, so facilitating the recognition of such bodies and the acceptance of their certifications both nationally and internationally. ISO/IEC 17021 will therefore serve as a foundation for facilitating the recognition of management system certification in the interests of international trade.

The requirements of the 2006 edition have not been changed except where they contradict those of the 2011 edition. ISO/IEC 17021 is also being published in an unofficial marked-up edition highlighting the new and deleted text. The new edition is to be reviewed one year after it has been in use to decide whether any first edition requirements need modifying to align them further with the new requirements.

ISO and the International Accreditation Forum (IAF) – the association of national accreditation bodies that declare the competence of certification bodies – have agreed on a two-year transition period from the date of publication of ISO/IEC 17021:2011 for certification bodies to bring their operations and processes in line with the requirements of the new edition.

ISO/IEC 17021:2011, Conformity assessment – Requirements for bodies providing audit and certification of management systems, was developed by the ISO Committee on conformity assessment (ISO/CASCO) and is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat, price 142 Swiss francs for the clean, official edition and 208 Swiss francs for the clean edition plus the unofficial marked-up edition, through the ISO Store or by contacting the Marketing, Communication & Information department.

MTs and CLSs Make List of Top Careers

MTs and CLSs Make List of Top Careers

Source : http://www.aacc.org/publications/cln/2011/february/Pages/topcareers.aspx

In its annual survey of high-demand careers, U.S. News & World Report named medical technologists (MT) and clinical laboratory scientists (CLS) among the top careers. The news magazine called clinical lab technicians and technologists “unsung heroes of the healthcare industry” in its 2011 list of the 50 best careers.

Clinical Pathology Laboratories Have Opportunity to Learn More about ISO 15189

Clinical Pathology Laboratories Have Opportunity to Learn More about ISO 15189    

January 13, 2011- Dark Daily Report

ISO 15189 is gaining a foothold among laboratories in the United States. Since the first clinical pathology laboratory in the U.S. earned accreditation to “ISO 15189:2007 Medical Laboratories” in 2008, there has been a steady increase in the number of clinical laboratories that have embarked on their own path to accreditation.

This fall, The Dark Report and Dark Daily invited all three of the organizations in North America that offer accreditation services for ISO 15189 to speak at the fourth annual Lab Quality Confab, which took place in San Antonio, Texas, on November 2-3, 2010. It marked the first time that all three of these ISO-accrediting organizations spoke in public at one time and in one place.        

The three North American ISO 15189 accreditation organizations who spoke at Lab Quality Confab were, alphabetical order:

• American Association for Laboratory Accreditation (A2LA), based in Frederick, Maryland.
• College of American Pathology (CAP), Northfield, Illinois.
• Quality Management Program-Laboratory Services (QMP-LS), Toronto, Ontario, Canada

Sessions featuring speakers from these three ISO accreditation organizations proved to be among the best-attended at Lab Quality Confab. There are two reasons for this high level of interest. First, most attendees at Lab Quality Confab are actively using Lean, Six Sigma, and process improvement methods. Thus, their medical laboratory is committed to ongoing improvement in the daily operation and workflow within their laboratory.

ISO 15189 is a QMS Tailored to the Needs of Medical Laboratories

Second, as clinical laboratories and pathology groups become more experienced at implementing ongoing improvements to different areas of workflow within their laboratory, they begin to understand the value of going to the next stage in their lab’s quality journey by implementing a true quality management system (QMS). Because ISO 15189 is a globally-recognized QMS, these laboratory professionals are quick to recognize how accreditation to ISO 15189 can directly benefit their medical laboratory.

Over the past 24 months, The Dark Report and Dark Daily have published stories about how the nation’s first clinical laboratories achieved accreditation to ISO 15189, along with the benefits that adoption of the ISO QMS has brought to these laboratories. One of the very first to earn ISO 15189 accreditation was the central laboratory at Avera Health in Sioux Falls, South Dakota. In the past 12 months, Spectra Laboratories, Inc., of Rockleigh, New Jersey earned its ISO 15189 accreditation. Spectra is one of the nation’s largest laboratory facilities, serving around 30,000 patients each day.

Medical Laboratory Technologists a U.S. News & World Report “Best Career” for 2011

January 5, 2011- Source : Dark Daily Report from US

Once Again, Medical Technologists (MT) and Clinical Laboratory Scientists (CLS) Are Top Careers   

Medical technologists (MT) and clinical laboratory scientists (CLS) were declared among “The 50 Best Careers of 2011” by U.S. News & World Report (USNWR) in its annual survey of high-demand careers. Editors at the respected news magazine declared “clinical lab technicians and technologists” to be the “unsung heroes of the healthcare industry.”

Medical technologists and clinical laboratory scientists had a prominent place in the USNWR’s special issue featuring “The 50 Best Careers of 2011,” published on Dec 6. 2010. MTs, pathologists, and clinical laboratory managers will see the MT and CLS career opportunity profiled under “Best Careers 2011: Lab Technician.”  

High Demand for Clinical Lab MTs, CLSs, MLTs, and Other Professionals

Each year, USNWR publishes its analysis of the “50 Best Careers.” In each of the past two years, Lab Technician has made the list. According to the editors of U.S. News & World Report:

• “Job growth is expected to be faster than average, with the number of clinical lab workers rising about 16% between 2008 and 2018, adding about 25,000 jobs, according to the Labor Department.
• “Median annual take-home pay was $36,030 in 2009. For those at the top of the pay bracket, salaries can be more than $55,210.
• “[Stress level] is pretty low, though hefty patient loads and keeping up with technological and regulatory issues can require some serious multi-tasking. You’ll be working in a clean, well-lighted lab most of the time.
• “The lower-cost education is a highlight of this occupation. For entry-level work, you’ll likely need to have an associate’s degree or complete a certificate program. It’s possible to learn some of your skills on the job.”

Predict Strong Job Growth and Above Average Income for MTs     

“To come up with this year’s list,” the report stated, “U.S. News considered job-growth projections from the Labor Department, estimates for 2008 to 2018, the most recent data available. We narrowed it down to occupations that are expected to add jobs at an above-average rate over the next decade, as well as those that provide an above-average median income.   

“We also considered, where possible, data on job satisfaction, turnover, and impending retirements, which crank up openings in jobs that may have only slightly above-average employment growth,” the report continued.     

This continues to validate the belief that demand for all sorts of technical healthcare positions will only increase, not only here in America, but in Canada and around the world. Healthcare systems on four continents have reported serious shortages in skilled technical employees in all aspects of healthcare. 

Dark Daily covered this topic in January with “Clinical Laboratory Technologists and Technicians Are Among Top Growth Jobs for Next Decade” after Lab Technician made it onto the U.S. News top careers list for 2010.  

With its selection of MTs and CLSs as “Best Careers for 2011,” U.S. News & World Report is signaling that demand for proficient clinical laboratory professionals will remain strong in coming years. That means that hiring practices at clinical laboratories must evolve as well.

On that point, Dark Daily recently reported on why clinical laboratories and anatomic pathology groups should be expanding their medical technologist recruitment programs to include the use of the Web and social media. These powerful new recruiting approaches were described during The Dark Report’s November audio conference titled “How to Solve Your Lab’s Med-Tech Recruitment, Hiring, and Retention Problems Now.”  

By selecting Laboratory Technologist as a “50 Best Careers for 2011,” U.S. News & World Report is affirming the ever-growing shortage of medical technologists and clinical laboratory scientists. Pathologists and clinical laboratory managers may want to incorporate this U.S. News & World Report story into the recruiting materials they use when hiring new laboratory staff.

 

New ISO standard aims to improve quality of learning services and facilitate comparison on worldwide basis

A new ISO standard aims to improve the quality of offerings on the global market that has grown up around non-formal education and training, such as vocational training, life-long learning and in-company training.

ISO 29990:2010, Learning services for non-formal education and training – Basic requirements for service providers, will also enhance transparency and allow comparison on a worldwide basis of learning services, offering a single alternative backed by international consensus to the huge variety of national service and management standards which now exists in the field of non-formal learning.

Knowledge is becoming a key factor in successful corporate management all over the world and education is increasingly being regarded as a business-oriented service.

The growing economic importance of learning in the global knowledge society has created new economic opportunities such as activity created by the provision of for-profit learning services. Quality assurance therefore becomes a crucial issue.

The objective of ISO 29990:2010 is to provide a generic model for quality professional practice and performance, and a common reference for learning service providers (LSPs) and their clients in the design, development and delivery of non-formal education, training and development.

The standard encourages a focus on the learner and the results of the process, and emphasizes the full range of options available for delivering learning services.

As it addresses the competency of LSPs., the standard will assist organizations and individuals selecting LSPs who will meet the their requirements and expectations for competency and capability development. In addition, it is envisaged that ISO 29990:2010 can be used to certify LSPs.

ISO 29990:2010 is the first standard developed by ISO technical committee ISO/TC 232, Learning services for non-formal education and training. Thomas Rau, Chair of the committee explains. “The purpose of TC 232 is to create a suitable framework for preparing standards in the field of non-formal learning services. Core elements are ensuring the quality and effectiveness of the education or training and improvement of knowledge transfer, whilst also enhancing the transparency and comparability of the range of learning services provided. ISO 29990 will help learning service providers improve their ability to consistently provide quality services, improve organizational effectiveness, and reduce overall business costs.”

ISO 29990:2010 is available from ISO national member institutes.
It may also be obtained directly from the ISO Central Secretariat, price 92 Swiss francs.

Source : http://www.iso.org