May 19, 2010 | Laboratory News, Laboratory Pathology
Use of synthetic antibodies and a finger prick sample of blood could give clinical laboratories new tool to screen for breast cancer
A simple clinical pathology laboratory blood test for early detection of breast cancer may be just around the corner. At the University of Arkansas (UA), researchers are building a library of synthetic antibodies called affitoids that can be used to detect breast cancer in its earliest stage.
Researchers believe they are closing in on the creation of an assay that can rapidly validate proteins secreted by microscopic breast cancer cells. “We want to implement a rapid screen that is sensitive, highly accurate, non-invasive and inexpensive,” said Shannon Servoss, Ph.D., Assistant Professor of Chemical Engineering at UA. “Such a test would be easy to use and applicable to women of all ages, races and ethnicities,” she said. “Hopefully we will be able to make the test sensitive enough so that only a finger prick [specimen] is needed.”
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Mar 31, 2010 | Laboratory News, Laboratory Pathology
Pathology labs would generally benefit if Judge Sweet’s ruling is upheld on appeal
It was positive news for many clinical pathology laboratories when a judge ruled against Myriad Genetics and the University of Utah Research Foundation in the federal suit attacking its patents for the BRCA1 and BRCA2 genes. The suit was brought by a group of patients, medical organizations and the American Civil Liberties Union (ACLU).
In Association for Molecular Pathology, et al v. U.S. Patent and Trademark Office 09-civ-4515, pathologist groups, patient advocacy groups, and the American Civil Liberties Union (ACLU) are challenging patents for the BRCA I and BRCA II genes which are held by the University of Utah and licensed exclusively to Myriad Genetics, Inc., (NASDAQ:MYGN) of Salt Lake City, Utah.
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Feb 12, 2010 | Laboratory News, Laboratory Pathology, Uncategorized
Court case will directly affect future development of new pathology and molecular tests
In New York’s Southern District Court, a trial is underway that tests the legality of patenting genes. In Association for Molecular Pathology, et al v. U.S. Patent and Trademark Office 09-civ-4515, pathologist groups, patient advocacy groups, and the American Civil Liberties Union (ACLU) are challenging patents for the BRCA I and BRCA II genes which are held by the University of Utah and licensed exclusively to Myriad Genetics, Inc., of Salt Lake City, Utah.
Many experts believe this lawsuit has the potential to produce new case law that addresses the ability of individuals and companies to hold patents on human genes. A ruling in favor of either party in the lawsuit will directly affect the clinical laboratory testing industry and diagnostic tests that utilize gene-based technologies.
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Oct 31, 2008 | Compliance, Legal, and Malpractice
Facing pressure by the Food and Drug Administration over its OvaSure test for ovarian cancer, Laboratory Corporation of America announced last Friday in a Securities and Exchange Commission filing that it had stopped sales of the test. The dispute between the FDA and the nation’s second largest laboratory company will be closely watched for insights into how the FDA regulates “home brew” assays.
In the October 20, 2008 issue of The Dark Report, an intelligence briefing provides an assessment on the issues of concern to the FDA about the OvaSure test for detection of ovarian cancer. It was these concerns which led the federal agency to send an initial letter and then a warning letter to LabCorp in recent months.
The current troubles swirling around the OvaSure assay represent two unfolding trends in laboratory medicine-and healthcare in general. One is the trend for new healthcare technology to have a demonstrated clinical benefit, along with a reasonable cost to achieve the improvement in clinical outcomes. Two is the repeated statements by the FDA that it sees the need for tighter oversight of diagnostic assays which incorporate molecular technologies.
The first trend came into play shortly after LabCorp, last June, began selling the OvaSure test as one method to detect cervical cancer. A number of physicians quickly criticized this decision. They argued that data from the clinical trials used to evaluate the OvaSure technology was not comprehensive enough to appropriately support how LabCorp recommended that physicians use the OvaSure test to detect cervical cancer. It didn’t take long before certain women’s health advocates also chimed in with criticism of LabCorp’s marketing of the OvaSure test. These criticisms were similarly rooted in a belief that the data from the clinical studies did not fully support the marketing claims for the test.
As to the second trend, the FDA seems to have noticed these public criticisms. It sent a letter to LabCorp late in the summer describing its concerns. Apparently, the FDA was not satisfied by whatever response was provided by LabCorp, because the agency then sent a warning letter to LabCorp earlier this month. In this correspondence, the FDA again questioned the adequacy of the clinical data used to support the manner in how the OvaSure test is marketed. The federal agency also, in its letters, noted that LabCorp was purchasing components of the test from Yale University and was thus not compliant with aspects of the home brew requirements.
By its actions, LabCorp has obviously decided that the best response to the FDA’s stop letter is to cease sale of the OvaSure test. This story has several chapters yet to come, depending on whether LabCorp wants to pursue its case with vigor and whether the FDA takes additional steps to rein in other home brew assays that many laboratories currently offer in today’s clinical marketplace.
For medical laboratories, there are two useful lessons to draw from the flow of events to date. First, a new laboratory test coming to market will have a much easier time gaining acceptance by physicians and payers if that test has strong clinical data to support its clinical efficacy, as well as its cost effectiveness.
Second, the FDA has once again served notice that it is concerned about home brew assays. This is not auspicious for the nation’s molecular testing laboratories, since any additional regulations will make it tougher for these laboratories to offer “home brew” assays to clinicians. It would also make it tougher for labs to gain additional knowledge about how home brew assays perform in clinical use.
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Oct 24, 2008 | Laboratory Management and Operations, Laboratory Pathology
Use of antibodies that detect biomarkers in as little as 15 minutes now allows researchers at the University of Leeds in the United Kingdom to identify such diseases as prostate and ovarian cancer, stroke, multiple sclerosis (MS), heart disease, and fungal infections. Using biosensors to identify the molecular markers for disease, the technology is much faster than current testing methods.
One goal of this research is to provide a way for hospitals to use this technology for rapid diagnosis. Another goal is to allow surgeons to use the technology to improve the speed and accuracy of referral to specialty physicians. Along with the ability to identify cancer, MS, heart disease, and infections, researchers say these biosensors may also be able to detect a wide range of analytes, including biomarkers in tuberculosis and HIV.
“We believe this to be the next generation diagnostic testing. We can now detect almost any analyte faster, cheaper, and more easily than the current accepted testing methodology,” said Paul Millner, M.D, a member of the faculty of Biological Sciences at the University of Leeds.
Researchers say that this technology could be developed into a device the size of a mobile phone, where different sensor chips could be inserted, depending on the disease being sought. “We’ve designed simple instrumentation to make the biosensors easy to use and understand,” Millner explained. “They’ll work in a format similar to the glucose biosensor testing kits that diabetics use.”
Currently blood and urine are tested for disease markers using test technologies such as ELISA (enzyme-linked immunosorbant assay). Developed in the 1970s, ELISA takes an average of two hours to complete, can be expensive, and can be performed only by highly trained staff.
The new biomarker technology was developed through a European collaboration of researchers and commercial partners in a 2.7 million Euro ($3.6 million) project called ELISHA (Electronic Immuno-Interfaces and Surface Nanobiotechnology: A Heterodoxical Approach).
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