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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 CEO Elizabeth Holmes to Show Scientific Data at AACC Conference

CEO SUMMARY: Theranos Founder and CEO Elizabeth Holmes will be in Philadelphia to present to the American Association of Clinical Chemistry (AACC) data about the technology developed at Theranos. Conference organizers said Holmes would answer ques- tions to clarify the science, accuracy, …

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AACC reveals details of its invitation to Theranos CEO

This is an excerpt from a 925-word article in the May 23 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group.  …

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Theranos in the News, for Better and Worse

IT’S BEEN AN EVENTFUL COUPLE OF MONTHS for Theranos, the lab testing company that says its goal is to disrupt the clinical laboratory industry. Novelists cannot write fiction as compelling as the unfolding real story about this controversial company. During March and April, The Wall Street Jou…

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Theranos Saga Just Keeps Getting More Intriguing

This is an excerpt from a 400-word article in the May 2 issue of THE DARK REPORT. The complete article is available paid members of the Dark Intelligence Group. …

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Henry Ford Health System Laboratory Division Combines Lean with ISO 15189

CEO SUMMARY: As healthcare transitions away from fee-for-service payment and adopts new models of reimbursement, every clinical lab will need to deliver more value with its lab testing services. At Henry Ford Health System in Detroit, the laboratory division has blazed a path of improving…

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Direct Access Testing Wars Are Heating Up

CEO SUMMARY: In Phoenix, where Theranos already operates patient service centers in about 40 Walgreens pharmacies, Sonora Quest Diagnostics has an agreement with Safeway to provide clinical laboratory testing service…

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2015’s Top 10 Lab Stories Show Significant Changes

CEO SUMMARY: During 2015, two stories captured the full attention of most pathologists and clinical lab managers. One was how CMS intends to gather lab price market data as mandated by PAMA. The other was the continued efforts by the FDA to move ahead on proposed guidance for regulation o…

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Washington Post: Theranos Approached Military in 2012

SINCE THE WALL STREET JOURNAL published its exposé of Theranos Inc. in October, other media outlets have published the findings of their own investigations into various aspects of the lab company’s practices. One example is the disclosure by The Wall Street …

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Might Lawsuits Come Next in the Theranos Story?

Tailored to the needs and interests of lab administrators and pathologists, THE DARK REPORT provides new insights into the continuing saga of Theranos. A stream of headline stories in recent weeks has painted the controversial lab testing company in an uncomplimentary way, and TDR p…

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Hospital CEOs Have Nothing to Fear from Theranos

FOR MORE THAN TWO YEARS, Theranos, the lab testing company that says it intends to disrupt the clinical lab industry, has been the subject of cover sto- ries in many prominent consumer and business publications. Its masterful public relations campaign seems to have touched almost eve…

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