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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Two Different Research Teams Announce Tests for Alzheimer’s Disease That Could Be Useful for Clinical Laboratories after Clearance by the FDA

A university research team and a global diagnostics company simultaneously but independently unveil two new tests that accurately identify people predisposed to Alzheimer’s at earlier stages in the disease

Medical laboratory scientists and clinical pathologists have long awaited an accurate and clinically-useful test for the predisposition and early diagnosis of Alzheimer’s disease. Now comes pioneering efforts from two organizations that suggest real progress is being made.

One organization is an academic center and the other is an in vitro company. It was a research team at Rowan University School of Osteopathic Medicine (RowanSOM) that announced development of the first blood test to use the body’s own immune system to detect mild cognitive impairment (MCI), an early stage of Alzheimer’s disease.

Similarly, research scientists for Randox Laboratories unveiled to pathologists, clinical laboratory leaders, and others attending the American Association for Clinical Chemistry (AACC) Annual Scientific Meeting, how their biochip-based technology also could be used to detect elevated risk for Alzheimer’s disease. (more…)

After AACC Presentation, Elizabeth Holmes and Theranos Failed to Convince Clinical Laboratory Scientists and the News Media about Quality of Its Technology

Clinical chemists at AACC pointed out that Holmes did not present data as promised. Instead, she did a speech that advertised her company’s latest medical lab analyzer

DATELINE: PHILADELPHIA—By now, the clinical laboratory industry and the world knows that Theranos Founder Elizabeth Holmes took the stage here last Monday at the annual meeting of the American Association of Clinical Chemistry (AACC). The content of her presentation was given wide play by the national press and, in general, Holmes appears to have failed to impress both the medical laboratory scientists in attendance and the journalists representing some of the world’s most prominent news outlets.

Among those in attendance was your Dark Daily editor, and I reported on the key elements of the presentation given by Holmes last week. However, the details contained within Holmes’ speech are only part of this important story. What is of equal or greater interest to medical laboratory professionals and pathologists is how their peers reacted to the invitation to have Holmes speak at the AACC meeting last week (a joint conference with the American Society for Clinical Laboratory Science—ASCLS), along with their reaction to what Holmes decided to present, their assessment of the diagnostic instrument she unveiled, and how they viewed the data she presented about certain assays performed by the Theranos “miniLab” device. (more…)

Theranos CEO Elizabeth Holmes Presents Scientific Data to Clinical Laboratory Chemists and Pathologists at AACC in Philadelphia

Yesterday’s presentation by Holmes was made to an audience that was clearly skeptical, and she was careful to avoid discussions about her company’s many issues and federal investigations

DATELINE: PHILADELPHIA, PA.—Yesterday, Elizabeth Holmes, CEO of Theranos, Inc., took the stage at the 68th AACC Annual Scientific Meeting & Clinical Lab Expo (AACC), the nation’s biggest clinical laboratory meeting, purportedly, for the first time ever, to deliver scientific data about her lab company’s diagnostic technologies. She also was there to answer questions from an expert panel before an attentive audience of clinical chemists and pathologists. A large number of journalists also were in attendance.

It may have escaped the notice of most of the audience—but not your intrepid editor—that the last song played over the PA system in the grand ballroom before Elizabeth Holmes was introduced and took the stage was “Sympathy for the Devil,” a big hit for The Rolling Stones in 1968. That song was an appropriate choice, since AACC’s invitation for Theranos to speak means the association is doing its own dance with the devil that some clinical chemists consider to be Theranos. (more…)

Recent Study Confirms that Clinical Laboratories and Pathologists Have an Opportunity to Help Educate Consumers in Key Health Information, such as Cholesterol, and Blood Glucose Levels

Reviewing medical laboratory test results online is a popular resource among consumers, says a different study by Kaiser Permanente

More than half of patients and consumers have trouble understanding their health information, along with the steps needed to further improve their health, according to a recent study conducted by HealthMine. This gap in consumer understanding represents a great opportunity for clinical laboratories and pathology groups that want to forge stronger bonds with patients and consumers.

In its survey of more than 7,200 healthcare consumers about their health knowledge, HealthMine determined that about 52% of consumers find it difficult to understand their health information and/or what is required of them to maintain or improve their health.

Knowledge of one’s health, or the health of a loved one, is critical to the management of chronic diseases and other health conditions. In this Internet age of patient portals and mobile health devices, the assumption is that most folks would be comfortable using the new technologies. Apparently, this is not the case. At least not among those HealthMine polled. (more…)

Texas Section of the American Association of Clinical Chemistry Hosts All-Star Line-up of Clinical Laboratory Experts to Share Successes at Improving Lab Test Utilization

Innovative medical laboratories are developing ways to deliver more value to physicians ordering and using lab tests

TEMPLE, TEXAS—Changes now happening to healthcare and the practice of medical laboratory medicine were upfront and personal here during last Friday’s meeting of the Texas Section of the American Association of Clinical Chemistry (AACC).

An impressive crowd of more than 120 pathologists, Ph.D.s, and clinical laboratory professionals were present to learn from an all-star panel of lab industry innovators. Space does not allow a full report of all 10 speakers who addressed this conference, but a nugget or two from three of the morning speakers will illustrate some of the latest thinking on how medical laboratories and pathology groups can make the transition from a transactional business model (fee-for-service payment) to a value-added clinical model (bundled or shared per-patient-per-month fee).

After an opening presentation by your Dark Daily editor, Robert L. Michel, who identified the primary dynamics propelling healthcare’s transformation, the next speaker launched into the key issue associated with how clinical labs and pathology groups can deliver value. (more…)

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