IVDT Insight

A team of scientists at GE Global Research, the technology development arm for GE has launched a study with Memorial Sloan-Kettering Cancer Center (MSKCC) to better understand the early stages of colon cancer. The goal is to yield new insights that improve treatment selection and outcomes for cancer patients in the future.
One of the primary issues in cancer diagnosis today is the limited amount of molecular information pathologists have about a particular cancer. At the time of diagnosis, little is determined about the characteristics of cancer itself such as how fast or slow it may be growing. New breakthroughs in molecular medicine are promising to change this paradigm.
Last October, GE scientists announced a major cancer research breakthrough in molecular pathology that is unlocking information about cancer previously hidden from view. This molecular information will not only increase our understanding of cancer; it could improve treatment selection for patients....

July 21st, 2010
0

deCODE genetics and ARUP Laboratories announced a partnership through which ARUP will offer deCODE’s DNA-based prostate cancer risk assessment test to its clients nationwide.
Under the terms of the non-exclusive agreement, ARUP will integrate deCODE ProstateCancer into the portfolio of tests it offers to leading academic medical centers, public and private healthcare providers, and major hospitals across the United States. ARUP’s clients will order the test, submit samples and receive results through ARUP, with deCODE conducting the genetic analysis in its CAP and CLIA-certified laboratory.
deCODE ProstateCancer measures 25 common single-letter variations, or SNPs, in the sequence of the human genome that are associated with the risk of prostate cancer. These SNPs were validated in tens of thousands of patients and controls in many populations. The risk conferred by these common SNPs is independent of family history, and does not correlate with benign...

July 20th, 2010
0

FDA can promote progress toward personalized medicine by approaching the oversight of laboratory developed tests (LDTs) in a focused, flexible, and balanced way, according to the American Clinical Laboratory Association (ACLA). ACLA, which represents the nation’s leading clinical laboratories, says that the factors supporting this approach include the growing role that such tests play in clinical decision making, especially in the area of new advanced diagnostics that derive from the mapping of the human genome and help fufill the promise of personalized medicine.
“It is clear that in a world of new science and genetic breakthroughs that the current regulatory systems are out-of-date and steps need to be adapted to bring them into the 21st Century,” said ACLA President Alan Mertz. “Lab-developed tests are improving patient care and quality on the front lines of medicine—from enabling dramatic improvements in survival rates for childhood leukemia...

July 19th, 2010
0

IBM announced plans to enlist some of the company’s leading scientists and technologists to help medical practitioners and insurance companies provide high-quality, evidence-based care to patients. As part of this initiative, IBM is collaborating with clinicians in medical institutions and hiring medical doctors to work alongside its researchers to develop new technologies, scientific advancements, and business processes for healthcare and insurance providers.
Dedicating $100 million over the next three years, the initiative will draw on IBM's leadership in systems integration, services research, cloud computing, analytics and emerging scientific areas – such as nanomedicine and computational biology – to drive innovations that empower practitioners to focus their efforts on patient care.
More than 100 researchers across IBM’s nine worldwide research laboratories and its collaboratories in Melbourne, Australia, and Taipei, Taiwan, are...

July 16th, 2010
0

Thermo Fisher Scientific Inc. and Intrinsic Bioprobes Inc. (IBI) announced an alliance to codevelop and market a mass spectrometry solution that will enable researchers to perform quantitative, high-throughput, high-resolution protein biomarker assays. The solution couples the specificity ofimmunoenrichment with the sensitivity and quantitative capability of mass spectrometry to provide researchers with a more complete, higher-resolution view of the proteome. Initially, via an exclusive reseller agreement, the solution will be applied to the detection of human parathyroid hormone (PTH) and its variants, which may be useful as biomarkers for bone diseases and diseases of the endocrine system.
As part of the arrangement, Thermo Fisher Scientific will integrate IBI’s proprietary immunoenrichment technology with Thermo Scientific automated sample handling and mass spectrometer systems. Scientists at the Biomarkers Initiatives in Mass Spectrometry (BRIMS) Center, a Thermo...

July 15th, 2010
0

Roche announced that the company has obtained a worldwide co-exclusive license for the biomarker PI3K (phosphoinositide 3-kinase) from Qiagen to develop real-time and endpoint PCR diagnostic assays. Johns Hopkins University owns the patent for the PI3K biomarker and has previously granted an exclusive license to Qiagen's wholly owned subsidiary DxS, now Qiagen Manchester. Financial details were not disclosed.

The PI3K pathway is mutated in more cancer patients than any other1, playing a significant role in colorectal, gastric, breast and endometrial tumors, among others. Drugs that inhibit PI3K are a significant focus of current cancer drug development. Genentech, a member of the Roche Group, has several molecules in early development targeting various points along this pathway, in a variety of tumor types.

Multiple scientific papers have shown that PI3K has the potential to be a clinically relevant biomarker for the prediction of individual response to specific...

July 14th, 2010
0

Cepheid has filed an answer and counterclaims in a patent suit brought by Abaxis on June 28, 2010 in the United States District Court for the Northern District of California. In its filing, Cepheid denied Abaxis' allegations of patent infringement, asked the Court to determine it has paid all royalties due and is in full compliance with all the terms of its license, and to find that Abaxis' patents are invalid.

In 2005, Cepheid entered into a royalty-bearing license agreement with Abaxis for certain patents relating to lyophilization technology. Since then, Cepheid has introduced an internally-developed manufacturing process outside the scope of Abaxis patents that has resulted in reduced royalty payments to Abaxis, although the Company continues to pay royalties associated with certain other products.

July 13th, 2010
0

Redwood Toxicology Laboratory Inc. (RTL) announced it now offers lab-based testing for the detection of JWH-018 and JWH-073 metabolites in urine. JWH-018 and JWH-073 are the primary synthetic cannabinoid receptor agonists responsible for the euphoric and psychoactive affects that imitate marijuana and are among the numerous compounds found in herbal incense or smoke blends. RTL laboratory analysis confirmed JWH-018 and JWH-073 as the active ingredients in 27 herbal mixtures, and established test methods to identify the presence of their metabolites.

RTL's test will utilize the most sophisticated, sensitive, and specific equipment and technology available, LC/MS/MS (liquid chromatography/mass spectrometry/mass spectrometry) to confirm JWH-018 and JWH-073 metabolites. This test methodology provides the most definitive synthetic cannabinoid biomarker test results.

The new RTL test panel is well suited for a variety of settings that have prevalent access to fake marijuana...

July 12th, 2010
0

Cepheid initiated a recall of all lots of Xpert MRSA/SA BC (blood culture) product. The recall is a corrective action, which does not require return of product to the manufacturer. Customers may continue to use the product; however, when an MRSA negative/SA positive result is obtained, the result should be interpreted as "MRSA indeterminate/SA positive, antimicrobial susceptibility testing pending." Further testing should be performed using a FDA-cleared, phenotypic antimicrobial susceptibility testing method on isolated colonies recovered from the blood culture bottle, as instructed in the Corrective Action Notice dated July 1, 2010. MRSA positive/SA positive results can still be reported as such. The new instructions will be incorporated in the product labeling. The Xpert MRSA/SA BC product produces false-negative MRSA results, which could potentially contribute to incorrect treatment of an MRSA infection.

Hospitals or laboratories that have purchased the Xpert...

July 2nd, 2010
0

Roche and IBM announced an agreement to develop a nanopore-based sequencer that will directly read and decode human DNA quickly and efficiently. Focused on advancing IBM’s recently published “DNA Transistor” technology, the collaboration will take advantage of IBM’s leadership in microelectronics, information technology and computational biology and Roche’s expertise in medical diagnostics and genome sequencing.

The novel technology, developed by IBM Research, offers true single molecule sequencing by decoding molecules of DNA as they are threaded through a nanometer-sized pore in a silicon chip. The approach holds the promise of significant advantages in cost, throughput, scalability, and speed compared to sequencing technologies currently available or in development.

Ultimately, the technology has the potential to improve throughput and reduce costs to achieve the vision of whole human genome sequencing at a cost of $100 to $1,000....

July 1st, 2010
0