Hamilton Robotics and Sorenson Forensics announce a collaboration to provide validated automation systems for DNA analysis in casework and databasing applications. Together, the two companies offer crime and government labs automated methods with a streamlined validation process for DNA extraction, normalization, PCR setup, amplification and cleanup. The pipetting performance and novel monitoring/audit trail features of Hamilton's STAR liquid handling platform combined with Sorenson Forensics' expertise in method validation provide an ideal solution for the forensic lab.

Hamilton's MICROLAB^® STAR automated pipetting workstation features unique air displacement pipetting technology for unmatched accuracy and precision, along with a proprietary Total Aspiration and Dispense Monitoring capability that monitors the air pressure in each pipetting channel in real time to verify that a sample has been successfully transferred. This provides a fully traceable audit trail and the documentation to support casework challenges.

Sorenson Forensics' team of DNA analysts has validated third-party chemistry kits and methods on the Hamilton MICROLAB STAR platform, documenting new ones as they are introduced. The Sorenson facility is ASCLD-ISO accredited and compliant with SWGDAM validation criteria and FBI QA Standards. Because the kits have already been independently validated, forensic lab customers can be confident that their own validation processes will go smoothly.

"Our TADM documentation delivers significant benefits to the forensic technicians who are increasingly being asked to testify in court about the validity of their work," says Rick Luedke, product manager for Hamilton Robotics. "Our partnership with Sorenson allows us to deliver fully supported methods for a majority of the leading forensic DNA applications."

Tim Kupferschmid, executive director of Sorenson Forensics, says, "Our validation team fully understands the specific requirements of DNA method validation and case submission. We chose the Hamilton MICROLAB STAR as our platform of choice due to their proprietary TADM technology and excellent reputation for strong applications and service support.

www.sorensonforensics.com

www.hamiltonrobotics.com

Carl Zeiss MicroImaging GmbH has received a license from the University of California for the commercialization of "superresolution," a microscopy technique offering extraordinarily high resolution.

The technique called "structured illumination microscopy" (SIM) was developed by scientists Mats G.L. Gustafsson, John W. Sedat and David A. Agard at the University of San Francisco.

The technology overcomes the classical diffraction limit to microscopic resolution by combining a special illumination pattern with state-of-the-art computational image analysis. Compared to a conventional microscope, the resulting superresolution images have up to double the resolution in all three spatial directions.   

The agreement grants Carl Zeiss the right to integrate the SIM technique into its microscope systems. With the ELYRA S.1 system, the supperresolution SIM technology will be available on standard microscopes for the first time.

With its ELYRA PS.1 system, Carl Zeiss is offering for the first time the combination of SIM with "photoactivated localization microscopy" (PAL-M) technology, another superresolution technique, in one system. This expands the experimental possibilities of modern light microscopy, opening up new horizons in cell biology and neurological research in particular.

www.zeiss.com/micro

A new CLSI guideline--Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns--for screening programs and special care personnel is designed to help detect treatable conditions before physical damage occurs to infants. Infants in special care baby units or neonatal intensive care units are at greater risk than normal newborns for missed or incomplete newborn screening.

"Many treatments given in special care nurseries, as well as conditions existing in the infant or the mother, can affect the reliability of newborn screening results," says Judith Tuerck, MS, BS, RN, Oregon State Public Health Laboratory, and co-chairholder for I/LA31-A. "This increases the chance that a preterm or ill infant affected with one of the screened conditions may not be diagnosed or may have diagnosis and treatment delayed."

Goals of the new guideline are to:

• ensure rapid, consistent and complete blood spot and hearing screening, including appropriate follow-up to ensure early diagnosis and treatment,
• minimize the risk of a missed or delayed diagnosis and treatment for all screened conditions,
• minimize the number of blood spot specimen collections and hearing screening events, and define essential elements of quality assurance relevant to these guidelines,
• provide education on the effects of special care baby unit treatments on newborn blood spot and hearing screening, and
• identify areas needing further research. 

Abbott and BG Medicine Inc. announce a development and commercialization agreement for galectin-3, a novel biomarker that may play a role in detecting the development and progression of heart failure. The assay will be developed for Abbott's ARCHITECT immunochemistry instrument platform, specifically the company's i1000SR and i2000SR instruments. The agreement grants Abbott a license to BG Medicine's intellectual property related to galectin-3.

"Heart failure is one of the most costly medical conditions in the world, with 37 percent of U.S. Medicare dollars alone spent on heart conditions each year," says Michael Warmuth, senior vice president, Diagnostics Products, Abbott. "Novel markers like galectin-3 have the potential to make important contributions to improving patient and economic outcomes as we work to better understand this deadly and costly disease."

Galectin-3 is a protein that plays an integral role in the biological functions related to the initiation and progression of cardiac fibrosis and scarring, which is a leading cause of heart failure. Several studies have shown that galectin-3 may provide valuable insight about heart failure and its underlying disease processes.

"This development and commercialization partnership with Abbott is an exciting opportunity to explore a promising diagnostic test with broad applicability in cardiovascular disease on a leading laboratory platform," says Pieter Muntendam, MD, president and CEO of BG Medicine. "BG Medicine's strong life science discovery research program combined with Abbott's scientific and development leadership will enable us to bring important new tests to patients and laboratories."

www.abbott.com

Roche`s RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus has received emergency use authorization (EUA) from the FDA. The Roche kit detects RNA from the 2009 H1N1 Influenza A virus and allows rapid and accurate identification of patients infected with this virus. It is important to differentiate patients infected with 2009 H1N1 virus from others with similar symptoms so that appropriate patient management can be commenced as early as possible. The efficacy of the Roche assay was demonstrated by clinical evaluation at worldwide study sites.

The RealTime ready Influenza A/H1N1 Detection Set is used in conjunction with the RealTime ready RNA Virus Master kit also provided by Roche. The assay is carried out on the Roche MagNA Pure LC platform for nucleic acid isolation and the LightCycler(® 2.0 system for real-time PCR; these instruments are available in labs worldwide. By providing detection reagents along with the master mix and necessary equipment, Roche is able to support all phases of the testing process for 2009 H1N1 virus.

"During the last months, our test proved to be reliable in many labs around the world," says Manfred Baier, who heads Roche Applied Science. "We are glad that, in granting the EUA, FDA now makes the test available also in the US."

EUA is a tool for approving public health countermeasures in the event of a national public health emergency. Under the current EUA, Roche can provide the RealTime ready Influenza A/H1N1 Detection Set to CLIA high-complexity labs for the duration of the declaration of emergency.

www.roche.com

PerkinElmer Inc. announces the company has received 510K clearance from the FDA for its GSP™ Genetic Screening Processor, which is used by public health laboratories worldwide as part of newborn screening programs.

In newborn screening programs, infants are tested for a range of genetic, metabolic or hematologic disorders. When identified within the first few days of life, these disorders are often easily managed, but if left untreated, could lead to serious illness or even death. The testing process begins with the collection of a few drops of blood from a heel prick.

The GSP system makes it much easier for labs to analyze newborn blood samples by providing the capability to run more than one test at once on very small samples. The GSP is an automated platform able to quantitatively and qualitatively analyze blood spot samples for irregularities associated with metabolic diseases that when detected early, can often be easily treated. With multi-analyte analysis capabilities and a two-fold capacity over prior systems, the GSP system delivers increased efficiency and flexibility over other methods, while reducing the risk of errors associated with manual processing of samples.

The GSP analyzer eliminates the need to analyze all samples in batches, permitting specimens to be processed as they arrive in the laboratory. This flexibility improves response time for delivering results to physicians and parents and eases the challenge of sample workflow management. Multi-analyte capability permits analysis for several analytes simultaneously, preserving the small sample volume for a wider range of analysis. The GSP Neonatal TSH assay is the first assay to receive FDA clearance for the GSP instrument. Several additional newborn screening assays are in development.

"FDA approval of PerkinElmer's GSP system provides laboratories in the U.S. with a next-generation system that can help address the staffing and workflow needs of today's demanding environment," says Ann-Christine Sundell, president, Genetic Screening, PerkinElmer. "This achievement reflects our ongoing commitment, as the global leader in newborn screening, to improving medical outcomes by developing the highest quality newborn screening solutions."

The GSP performs each stage of the assay process, from the retrieval of the sample plate to sample measurement, and reporting of results in a single platform. All-inclusive technology allows operational efficiency by accelerating workflows and reducing hands-on time, which, when combined with the availability of barcoding, reduces the risks of human error.

The GSP analyzer is designed to be flexible and can be seamlessly integrated into a range of lab operations. The processor will allow for both multi-analyte screening as well as the ability to run traditional immunoassays or enzymatic-assays, thus accommodating varying workflows. Other design features that address common laboratory challenges include the ability to continuously load samples, the refrigeration of onboard reagents, and the integration of direct access to water and waste lines to streamline processes and dedicated software.

www.perkinelmer.com

The United States Senate unanimously confirmed Dr. Regina Benjamin, a former member of  COLA's Board of Directors, as the nation's next Surgeon General on Oct. 29.

Dr. Benjamin, a family physician from rural Bayou La Batre in coastal Alabama, was nominated to the post in July by President Barak Obama. A member of COLA's Board of Directors in the mid-1990s, Dr. Benjamin has a unique understanding of laboratory accreditation issues and offers a wealth of varied experiences and qualifications to this position.

Verlin Janzen, MD, chair of the COLA Board said, "The United States Senate is to be commended for unanimously confirming this superb physician to this critical post, especially at this challenging time as our nation confronts the H1N1 virus. COLA congratulates Dr. Benjamin or her new position, and is confident that she will bring awareness and understanding of the important roles of both medical laboratories and CLIA."

Dr. Benjamin is well-known for her Alabama non-profit clinic which was destroyed by Hurricane Katrina, rebuilt, and then destroyed again by fire. Undaunted, the practice was rebuilt yet again, where Dr. Benjamin spent several days a week caring for patients in addition to making house calls to shut-ins.

In the mid 1990s, Dr. Benjamin was the first African American woman to serve on the Board of Trustees of the American Medical Association (AMA). She has also served as chair of the AMA Council on Ethical and Judicial Affairs.

She is a member of the Institute of Medicine of the National Academy of Sciences, and also serves on the Board of the Robert Wood Johnson Foundation. Dr. Benjamin is immediate past chair of the Federation of State Medical Boards. Last fall, she was a recipient of the prestigious McArthur Foundation "Genius Award" for her ongoing work in providing health care to underserved populations.

www.cola.org