Oct 17, 2011 | Laboratory News, Laboratory Pathology
New cancer test may be as easy as a home-use pregnancy test
Early detection of certain types of cancer may eventually become as easy as taking a home pregnancy test. That’s the prediction of researchers who are developing a non-invasive early diagnostic test for gastric cancer that would not require a pathologist to assess a tissue specimen. Instead, this test detects biomarkers in the patient’s urine.
Surgical pathologists will recognize the potential of this discovery to create new tools for diagnosing cancer at earlier stages—and without the need to collect a tissue specimen. For clinical laboratories, the possibility of a urine-based test that could accurately detect different cancers would make it possible for them to offer diagnostic assays based on this technology to office-based physicians.
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Feb 22, 2010 | Digital Pathology, Laboratory News, Laboratory Pathology
Firm will submit cytogenetic testing system to FDA using pre-IDE process
High-throughput microarray technology used in cytogenetics research may soon have an FDA-cleared product for use by clinical pathology laboratories.
Array-based comparative genomic hybridization can perform the equivalent of hundreds or even thousands of fluorescence in situ hybridization (FISH) experiments in one array. This technology has become the preferred method for molecular cytogenetics research. Recent advances in the technology are making the system appropriate for use by clinical labs and at least one manufacturer is taking steps to enter this market. (more…)
Dec 18, 2009 | Laboratory News, Laboratory Pathology
Researchers say Mobidiag’s microarray-based diagnostic test technology looks promising
There’s a new DNA-based microarray platform that could speed identification of blood-borne pathogens. By allowing clinical laboratories to deliver test results in just 18 hours, use of this new microarray could improve early detection and management of sepsis patients.
In a study headed by Päivi Tissari, M.D., of the Division of Clinical Microbiology, Helsinki University Hospital Laboratory in Finland, the Prove-it sepsis assay, manufactured by Helsinki-based Mobidiag, demonstrated 94.7% clinical sensitivity, 98.8% specificity, along with 100% sensitivity and specificity for methicillin-resistant Staphylococcus aureus bacteremia. The conventional process of growing a culture—the medical laboratory’s gold standard—typically takes between one to three days to become positive and two more days to identify the bacteria and their antibiotic sensitivity patterns. Mobidiag’s Prove-it sepsis assay returns results in only 18 hours.
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May 14, 2009 | Laboratory News, Laboratory Pathology
It may be that personalized medicine is becoming one of those All-American icons, like apple pie and mom. That’s because personalized medicine, as a concept and goal for the American healthcare system, seems to have universal support. If true, this is a positive long-term development for clinical laboratories and pathology groups.
Take the new president, for example. Barack Obama has long contended that personalized medicine must be at the heart of health care reform. “The issue of getting the right treatment to the right person goes with his [Obama’s] whole emphasis on health reform,” said Mark McClellan, who headed the FDA and Medicare under the Bush Administration. McClellan was speaking about President Obama during an interview with MSNBC. “If we’re thinking about reforming the healthcare system, we should be thinking about what medicine will be like down the road when healthcare reform is fully implemented,” observed McClellan during his MSNBC interview.
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May 11, 2009 | Laboratory News, Laboratory Pathology
Nation’s largest public health district wants to promote personalized medicine
Here’s an unusual development in genetic testing that shows clinical laboratory managers how fast the lab testing marketplace is changing. Two-hospital Palomar Pomerado Health (PPH), California’s largest public health district, recently partnered with 23andMe to introduce a personalized medicine service in North San Diego County.
PPH now sells 23andMe genetic test kits for $399 at express care centers in two grocery stores and an outpatient center. The test kit, Time magazine’s 2008 pick for Invention of the Year, comes with a 30-minute education session by a nurse practitioner.
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