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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.

How Many Patients Were Harmed at Theranos?

CEO SUMMARY: Reporting in The Wall Street Journal shows that some physicians in Arizona were concerned about the harm from erroneous test results from Theranos Inc. But those physicians who expressed concern may have been only a small set of the …

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SEC Charges Theranos with ‘Massive Fraud’

CEO SUMMARY: In an action against Theranos and two of its executives, the SEC said in a federal court filing this month that the company, CEO Elizabeth Holmes, and former COO Ramesh “Sunny” Balwani deceived investors into believing that the company’s portable blood analyzer could co…

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FDA Clears Waived CBC For Near-Patient Testing

CEO SUMMARY: Market clearance of the first-ever CLIA-waived analyzer for complete blood count and three-part differential tests could cut time-to-answer from days to mere minutes for one of the top 20 tests by volume performed at core laboratories. Developer Sysmex America, Inc., foresees…

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Mass Spec Tests Struggle To Gain Insurers’ Attention

CEO SUMMARY: Since 2014, a toxicology lab at the University of Colorado has used mass spectrometry to offer low-cost, accurate multi-analyte test panels that can detect hundreds of therapeutic drugs and drugs of abuse. However, CU Toxicology’s chief medical officer says health insurers …

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PAMA Data Projections Led to Decision to Sell Lab

CEO SUMMARY: Following passage of the Protecting Access to Medicare Act of 2014, officials at PeaceHealth and PeaceHealth Laboratories began to model the financial effect this law would have on this long-established hospital lab outreach program. Based on projections of a 20% cut in reven…

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PAMA Economics Drives Merger Of Two Seattle-Area Pathology Groups

CEO SUMMARY: Among the three chief reasons for the merger of CellNetix and Puget Sound Institute of Pathology, the most compelling was the need to address the challenges in the current reimbursement environment and to prepare for reductions in payment to pathologists expected in the comin…

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Elizabeth Holmes of Theranos Speaks at AACC To Skeptical PhDs, Pathologists, and Press

CEO SUMMARY: Elizabeth Holmes, Founder and CEO of Theranos, Inc., was given the ideal platform by AACC to show the science behind her lab company’s much-touted diagnostic technologies. But in a surprise to the assembled audience, Holmes, accompanied by three PhDs on her team, chose to d…

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Score for Theranos after AACC: Fail.

This is an excerpt from a 1,600-word article in the August 15 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …

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Genetic Testing Lab Finds Payers Respond To Education on Test Utility

CEO SUMMARY: In recent years, insurers have raised the bar and become much tougher when making coverage and reimbursement decisions for molecular assays, genomic, and genetic tests. Yet several lab testing companies are having good success at demonstrating the validity and clinical utilit…

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Is Theranos Kowtowing To CMS over Pending CLIA Sanctions?

CEO SUMMARY: Having ignored the profession of laboratory medicine for nearly all of its 13-year corporate life, Theranos suddenly began engaging with expert laboratorians last month. The timing of this new outreach coincides with public disclosure that CMS proposed the severest sanctions …

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