Nov 14, 2014 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Developers seeking FDA Approval for microchip-based nanotechnology type-1 diabetes test, which has been performed on people with accurate results
New nanotechnology has made it possible for a team at Stanford University School of Medicine to develop a medical laboratory test for type-1 diabetes that can be performed in a physician’s office and does not require a specimen collected by venipuncture.
This microchip requires just minutes to diagnose type-1 diabetes in near-patient settings, according to a Stanford University news release. (more…)
Sep 3, 2014 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
It was national news when the FDA sent notice to Congress on July 31 that it planned to issue draft guidance on regulation of LDTs
After sitting in a state of suspended animation for several years, the Food & Drug Administration’s (FDA) plans to regulate laboratory-developed tests are now front and center. On July 31, the FDA served the required 60-day legal notice to Congress that it was ready to move forward to issue rules for regulation of LDTs.
If the federal agency wanted to get the full attention of the clinical laboratory industry, it certainly succeeded. In the four weeks since the FDA alerted Congress of its plans for LDT regulation, there has been a flood of national news stories about this development. (more…)
Aug 13, 2014 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
It took UCSF physicians just 48 hours to identify the bacteria in cerebrospinal fluid that was causing fourteen-year-old Joshua Osborn’s hydrocephalus and status epilepticus
There’s rich irony in the FDA’s recent announcement that it would move forward with plans to regulate “laboratory-developed tests ” (LDTs) just weeks after the national media published stories about how innovative use of an LDT helped physicians make an accurate diagnosis that saved the life of seriously-ill 14-year old boy.
Pathologists and clinical laboratory managers may be aware of the case of Joshua Osborn. It was a laboratory-developed test that used next-generation gene sequencing in a unique approach that gave his care team the diagnostic information they needed to select the right therapies for his condition.
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Jun 28, 2013 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology
FDA intends to pursue regulation of laboratory-developed tests (LDTs) as medical devices, according to FDA Commissioner Hamburg
FDA regulation of laboratory-developed tests (LDTs) is getting attention again. In recent weeks, FDA Commissioner Margaret Hamburg, M.D. put the clinical laboratory industry on notice that the commission intends to pursue regulation of LDTs.
Pathologists and clinical laboratory scientists have long used LDTs to solve clinical diagnostic problems and as a way to use new technologies to address unmet clinical challenges. As a result, these medical laboratory tests are critically important to the growth of personalized medicine. (more…)
Jun 11, 2010 | Laboratory News, Laboratory Pathology
Times reporter looks at issues affecting accuracy of different breast cancer tests
Pathologists should consider a recent story about breast cancer testing in the New York Times to be a warning flag, similar to the warning flags that the Coast Guard flies along the coast to warn of an approaching hurricane. The subject of the story was “unclear tests” used to identify whether a breast cancer patient is a candidate for certain therapeutic drugs.
The New York Times story was in response to the public release of new guidelines for processing specimens used in estrogen receptor and progesterone receptor (ER/PR) testing for breast cancer. The guidelines were announced by the College of American Pathologists and American Society of Clinical Oncology (ASCO) on April 19, 2010. One goal of the new guidelines is to improve “the accuracy of immunohistochemistry (IHC) testing for the expression status of estrogen (ER) and progesterone receptors (PgR) in breast cancer” as performed by the hundreds of anatomic pathology laboratories in the United States which perform ER and PR testing.
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