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Diagnostic technology
Diagnostic technology involves tests, assays and equipment that allow clinical labs to diagnose diseases. New diagnostic technologies are currently transforming both infectious disease testing and cancer testing. Rapid molecular tests, for example, make it possible for medical labs to deliver an accurate answer back to a referring physician in just hours—compared to the several days that are required for most long-standing microbiology test procedures.
Even more disruptive technologies include digital pathology and MALDI-TOF mass spectrometry. Digital pathology is an image-based information environment that is enabled by computer technology to allow for the management of information generated from a digital slide. Digital pathology is enabled in part by virtual microscopy, which is the practice of converting glass slides into digital slides that can be viewed, managed, and analyzed on a computer monitor. With the advent of Whole-Slide Imaging, the field of digital pathology has exploded and is currently regarded as one of the most promising avenues of diagnostic medicine in order to achieve even better, faster and cheaper diagnosis, prognosis and prediction of cancer and other important diseases.
MALDI-TOF (matrix assisted laser desorption ionization-time of flight) mass spectrometry allows clinical laboratories to identify small aerobic gram-positive bacilli more accurately, faster, and in a more cost-effective manner than ever. It enables the analysis of biomolecules (biopolymers such as DNA, proteins, peptides and sugars) and large organic molecules (such as polymers, dendrimers and other macromolecules), which tend to be fragile and fragment when ionized by more conventional ionization methods.
Even as pathologists are working to develop more sensitive and accurate diagnostic tests for cancer, similar efforts are underway in radiology and imaging. In fact, one research team has developed a self-assembling nanoparticle that can adhere to cancer cells, thus making them visible in MRI scans and possibly eliminate the need for invasive tissue biopsies.
Researchers have developed a self-assembling nanoparticle that targets cancer cells and makes them visible on magnetic resonance imaging (MRI) scans. The new nanoparticle improves MRI scanning efficacy by “specifically seeking out receptors that are found in cancerous cells,” according to researchers. Were this development to become a reality, it has the potential to alter anatomic pathology’s role in diagnosing cancer.
Did Theranos Turn Over its CLIA Lab Director?
PROBABLY NO SINGLE LAB INDUSTRY STORY OF THE PAST 24 MONTHS has generated a higher level of curiosity among pathologists and lab administrators than that of Theranos, the Palo Alto, California-based company that regularly claims it has the technology, the business model, and the low price strategy ne…
Top 10 2014 Biggest News Stories
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…
PAMA, LDTs and Theranos Top 2014 Biggest News
CEO SUMMARY: Not in recent memory has a single calendar year brought such a cascade of news stories that have the potential to affect nearly every clinical lab and pathology group in the United States. Blame it on the lack of money to fund healthcare and how it is motivating government an…
Theranos Pursues Different Business Plan in Arizona
CEO SUMMARY: Since its big public debut in late 2013, Theranos has been the subject of keen interest and much skepticism among pathologists and clinical laboratory professionals. Theranos is expanding its presence in Phoenix, Arizona. However, as it does, it looks more like a conventional…
Ignoring Lab Industry, Theranos Goes Its Way
CEO SUMMARY: With each passing month, Theranos pulls open the curtain a bit more on its business structure and its market growth plans. Its clinical lab tests are now offered in Walgreens pharmacies in Palo Alto, California, and Phoenix, Arizona. Recent news coverage in Fortune and USATod…
My Visit to Walgreens for Theranos Lab Tests
CEO SUMMARY: One of the biggest unknowns in the lab testing industry today is Theranos, the lab testing company based in Palo Alto, California. It says its proprietary technology is poised to transform the lab testing experience for patients and physicians. It says it can perform hundreds…
‘Game Changer’ Mass Spectrometry for Microbiology at UNC
CEO SUMMARY: Microbiologists at the University of North Carolina are using MALDI-TOF mass spectrometry to slash the time to answer and significantly cut lab costs. Their goals are to improve patient outcomes and reduce average length of stay. In a one-year study presented last month, UNC …
Clinical Labs Spending Money in New Ways
CEO SUMMARY: In response to the many changes now unfolding in the U.S. healthcare system, labs are investing their scarce capital in different ways. Five trends in lab spending can be identified. They range from expanding the informatics capabilities of a lab organization to acquiring the…
Genetic Testing Creates New Legal Risks for Labs
CEO SUMMARY: Last month, in Seattle, Washington, a jury ordered Laboratory Corporation of America and Valley Medical Center each to pay $25 million following a lawsuit about a ‘wrongful’ birth. At issue was how genetic tests were ordered, performed, and reported. This court case is th…
Theranos Won’t Discuss Disruptive Lab Technology
CEO SUMMARY: In a partnership with Walgreens pharmacies, Theranos Inc. announced that it will run clinical lab tests on “micro-samples” and collect these blood samples without venipuncture. Even as Theranos touts the patient-friendly benefits of its proprietary diagnostic technology, …
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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