News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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IBM Watson Health to Acquire Truven Health Analytics and Its Millions of Patient Records for $2.6 Billion

IBM Health’s data combined with Truven’s patient records will create an enormous big-data collection representing 300 million patient lives

If any pathologist or clinical laboratory manager still doubts the importance of healthcare big data, the multi-billion-dollar acquisition of Truven Health Analytics by IBM should put those doubts to rest.

Last month, IBM Corp. (NYSE:IBM) announced an agreement to acquire Truven Health Analytics, (Truven) for $2.6 billion. Truven is a provider of cloud-based healthcare, analytics, and insights and is based in Ann Arbor, Michigan. (more…)

FDA’s New Next-Generation DNA Sequencing Platform Intended to Increase Collaboration among Scientists, Pathologists, and Clinical Laboratory Experts

Federal agency hopes its open-source precisionFDA web portal will aid in development of laboratory-developed tests and inform regulatory decision-making

One recent initiative launched by the Food and Drug Administration (FDA) to foster the greater sharing of genetic information may be of some value to pathologists and clinical laboratory scientists  who are developing laboratory-developed tests (LDTs) that incorporate molecular and genetic technologies.

The FDA unveiled an open-source platform for community sharing of genetic information. It is called precisionFDA, and the FDA describes its new web platform as an “online, cloud-based portal that will allow scientist from industry, academia, government, and other partners to come together to foster innovation and develop the science” of next-generation DNA sequencing processing. (more…)

For Embattled Medical Laboratory Company Theranos, Bad News Keeps on Coming After Two Federal Inspections Show Problems in Certain Lab Practices

High rates of variability from one drop to another raise questions about the reliability of point of care testing equipment and companies that collect lab specimens only with finger sticks

Since last fall, one news report after another has come out with bad news for Theranos Inc., the high-profile medical laboratory company. The reports have ranged from dissatisfaction among Theranos’ partners, such as Walgreens and Capital BlueCross, to failed inspection reports from the federal Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA).

In response, the embattled lab company in Palo Alto, Calif., has maintained that it is doing everything it can to correct any deficiencies in its clinical laboratory testing methods and to ensure its partners that its processes are scientifically sound and its methods valid. (more…)

Google Files Patent for Needle-free Blood Draw System That Could Eventually Remove Clinical Laboratories and Pathology Groups from the Process

Patent filing describes a device that is intended to allow patients to collect their own blood specimens without the need for needles

Google, (now known as Alphabet, Inc.; NASDAQ:GOOG) recently filed an application for another patent that deals with medical laboratory test technology. This patent application is for a needle-free blood draw system that enables patients to perform diagnostic testing on themselves.

The new system is designed to replace painful finger pricks and deliver diagnostic test results digitally to providers’ electronic health record (EHR) systems. Should the technology make it through clinical trials, widespread adoption of such a device could have sweeping implications for pathologists and clinical laboratories across America. (more…)

Comparison of In Vitro Diagnostic Industry’s Top Five Trends for 2015 and 2016 Reveals Rapid Technology Advances Intended to Give Clinical Laboratories New Diagnostic Tools

Of the five trends described in a report published by Kalorama, only two made the list for both years: Consolidation within the IVD industry and growth in molecular point of care

What a difference one year can make in the most significant trends influencing the in vitro diagnostics (IVD) industry, which also influences clinical laboratories, the largest customers of IVD manufacturers. These insights come from comparing the top five IVD trends for 2016 as identified by Kalorama Information from its top five IVD trends that it says dominated during 2015.

Kalorama is a division of MarketResearch.com, a company that publishes market research in the life sciences. In a report titled, “Five IVD Market Trends to Watch for in 2016,” it published its picks for the top five trends in IVD testing for 2016. The five most prominent trends recognized by the healthcare research marketer are as follows: (more…)

Virus Attacks Hospital’s Medical Laboratory Department Computers, Crippling Workflow and Spreading to Other Departments

Incident highlights need for anatomic pathology and clinical laboratories to protect computer and LIS systems from hackers and malware

Anatomic pathology labs and clinical laboratories that continue to run Microsoft Windows XP on their computer systems now have a real threat to address. In Australia, the computers in a hospital’s medical laboratory were infected in January with a computer virus that shut down the system. To maintain clinical services, the lab staff was forced to use paper-based methods, among other solutions.

The computer virus crippled the pathology department at the Royal Melbourne Hospital and spread throughout the hospital system by targeting computers running Microsoft Windows XP. This is a 14-year-old operating system that Microsoft no longer supports.

According to a story in iTnews, the Qbot malware first infected computers in Royal Melbourne Hospital’s pathology department in mid-January, handcuffing the pathology department. Staff was forced to develop manual workarounds to process specimens and to record and communicate results. (more…)

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