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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.
Theranos Won’t Discuss Disruptive Lab Technology
By Joseph Burns | From the Volume XX No. 13 – September 30, 2013 Issue
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, …
PeaceHealth Lab Helps Docs with Info to Improve Outcomes
By Joseph Burns | From the Volume XX No. 11 – August 13, 2013 Issue
CEO SUMMARY: Described by its CEO as “an information company that happens to do laboratory testing,” PeaceHealth Laboratories of Springfield, Oregon, is moving swiftly to develop and deliver value-added services to its client physicians. The lab’s goal is to help re…
Mass Spectrometry Is Finding Larger Role in Clinical Labs
By Joseph Burns | From the Volume XX No. 4 – March 25, 2013 Issue
CEO SUMMARY: Mass spectrometry is a diagnostic technology that is transforming clinical labs and improving care at a rapid pace. The current generation of instruments is capable of supporting a faster time-to-answer and provides improved accuracy and specificity over many existing methods…
Boosting the Lab’s Role in Collaborative Care
By Joseph Burns | From the Volume XX No. 1 – January 22, 2013 Issue
CEO SUMMARY: Collaborative care is an essential element of accountable care organizations (ACO) and other emerging models of integrated clinical care. At MedCentral Health System, one clinical chemist has held a key place on the physician team that develops order sets and clinical alerts….
November 19, 2012 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XIX No. 16 – November 19, 2012 Issue
Only one clinical lab industry vendor made the inaugural list of the Modern Healthcare’s fastest- growing health companies. It was Sysmex America, of Mundelein, Illinois. Sysmex ranked number 26 on a list of 40 healthcare companies. Modern Healthcare reported that…
Securing your Lab’s Success as Healthcare Reforms
By R. Lewis Dark | From the Volume XIX No. 5 – April 2, 2012 Issue
IT IS PROBABLY SAFE TO ASSUME THAT MOST OF YOU RECOGNIZE that the American healthcare system is about to undergo its most extensive transformation of the past 50 years. For better or for worse, we are about to see the end of medicine dominated by fee-for-service reimbursement and a fragmented deliver…
Rosetta Genetics, Aureon Biosciences, Plus Diagnostics, Atherotech, Sequenom
By Robert Michel | From the Volume XVIII No. 14 – October 17, 2011 Issue
ROSETTA GENOMICS TO LAY OFF 35 EMPLOYEES TO CUT EXPENSES AND SHIFT MORE FUNDING toward sales of its proprietary molecular tests, Rosetta Genomics says it will eliminate 35 jobs. The company, based in Israel, operates a clinical laboratory in Philadelphia, Pe…
Several Laboratory Companies On Road to Public Stock Offering
By Robert Michel | From the Volume XVII No. 16 – November 15, 2010 Issue
ONE OF THE FEW PUBLIC STOCK OFFERINGS involving a lab testing company was completed last Wednesday. Exact Sciences, Inc., of Madison, Wisconsin sold $69 million worth of new shares to the public. Exact Sciences has proprietary diagnostic technology that it describes as “for noninv…
May 10, 2010 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XVII No. 7 – May 10, 2010 Issue
Just four years since its founding in June, 2006, Aurora Diagnostics, Inc., of Palm Beach Gardens, Florida, is preparing to go public. On April 30, the company filed stock registration documents with the Securities and Exchange Commission (SEC) for an IPO (initial pu…
New Clinical Lab Trends To Shape Events in 2010
By Robert Michel | From the Volume XVII No. 1 – January 4, 2010 Issue
CEO SUMMARY: In presenting this list of macro trends for clinical laboratories, several themes are in play. They range from a continued emphasis on improving lab operations to the need to acquire and deploy sophisticated information technology. During the next few years, the long…
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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