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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Recently published White Paper discusses the importance of clinical diagnostics laboratories having a capable system to handle molecular testing needs

The laboratory industry’s forward thinkers define molecular diagnostics and genetic testing as both the future of pathology and the #1 opportunity to add clinical value while earning appropriate reimbursement.

Personalized medicine and predictive medicine have become a reality. As molecular technology and personalized medicine increasingly becomes the default position for clinical diagnostics laboratories, these modalities place significant demands on laboratory information systems. Although hospitals and healthcare institutions often focus on an electronic medical records system that includes a laboratory information system (LIS), those LIS’s do not typically have the functionality needed to handle current molecular testing needs, or needs expected in the near future.

DarkDaily.com is pleased to offer a recently published White Paper that discusses the trends in increasing use of genetic and molecular testing, the growth of big data in healthcare, and the challenges facing laboratories in handling the complexities of personalized medicine. (more…)

Now Theranos Faces Criminal Investigation on Whether the Clinical Laboratory Company Misled Investors, according to Published Reports

Latest news follows reports that Theranos was facing sanctions that include revoking its CLIA license and a two-year ban on its executives Holmes and Balwani and its former medical director, Dhawan

Federal prosecutors began a criminal investigation into whether Theranos misled investors about its medical laboratory technology and operations, The Wall Street Journal (WSJ) reported on Monday evening.

Investigators recently sent subpoenas to Walgreens Boots Alliance Inc. (NASDAQ: WBA) and the New York State Department of Health (NYSDOH) seeking documents and testimony about statements Theranos made, according to WSJ reporters Christopher Weaver, John Carreyrou, and Senior Editor Michael Siconolfi. As sources, the WSJ cited unnamed people familiar with the matter. (more…)

Human Longevity Inc. Unleashes Power of Whole-Genome Sequencing to Unlock Keys to Healthy Aging; Research May Lead to New Clinical Laboratory Tests

Human genome pioneer J. Craig Venter’s newest project seeks to ‘change the way medicine is practiced’ by creating genomic-based medicine model

With little fanfare or public notice, a start-up company in San Diego is busy sequencing the largest number of whole human genome sequences in the world. The knowledge expected to result from this effort promises to revolutionize healthcare, as well as clinical laboratory testing.

Human Longevity Inc. (HLI) is a genomics and cell therapy company that has assembled the largest human genome sequencing operation in the world. It’s goal is to use whole genome sequencing and cell-based therapeutics to redefine aging and “meaningfully extend the human lifespan.”

“HLI’s mission is to identify the therapeutically targetable mechanisms responsible for age-related human biological decline, and to apply this intelligence to develop innovative solutions to interrupt or block these processes, meaningfully extending the human lifespan,” HLI states on its website. “We are trying to tackle some of the most vexing diseases like cancer, heart disease, and diabetes … we are working to change the way medicine is practiced through our genomic-focused, preventive model.” (more…)

CMS Notifies Theranos of CLIA Sanctions That Include Revoking Clinical Laboratory’s CLIA License and a Two-Year Ban on Holmes, Balwani, and Dhawan

Wall Street Journal obtained copy of letter sent by CMS to Theranos, dated March 18, 2016, that notified its executives of sanctions that include revocation of Theranos’ CLIA license and a process by which the medical lab company can appeal

Theranos, the high-profile clinical laboratory company, had a day of reckoning yesterday. That’s when The Wall Street Journal (WSJ) published a story revealing that Theranos was sent a letter by the federal Centers for Medicare & Medicaid Services (CMS) providing notice of sanctions.

In a letter to Theranos executives, CMS said it is prepared to:

• revoke the company’s CLIA certificate;

• impose a fine of $10,000 per day;

• suspend and cancel the lab’s approval to receive Medicare payments; and

• impose a two-year ban on the owner, operator, and laboratory director for owning or operating a clinical laboratory.

Dated March 18, the letter is addressed to Sunil Dhawan, MD, Director; Elizabeth Holmes, Owner; and Ramesh Balwani, Owner. (more…)

3D Imaging of Cancer Cells Could Lead to Improved Ability of Pathologists and Radiologists to Plan Cancer Treatments and Monitor Cell Interactions

New technology from researchers at the University of Texas Southwestern Medical Center enables the ability to study cancer cells in their native microenvironments

Imaging research is one step closer to giving clinicians a way to do high-resolution scans of malignant cells in order to diagnose cancer and help identify useful therapies. If this technology were to prove successful in clinical studies, it might change how anatomic pathologists and radiologists diagnose and treat cancer.

Researchers at the University of Texas Southwestern Medical Center developed a way to create near-isotropic, high-resolution scans of cells within their microenvironments. The process involves utilizing a combination of two-photon Bessel beams and specialized filtering. (more…)

Why Whole Human Genome Sequencing Is Poised to Transform Patient Care Is Key Theme at 21st Annual Executive War College on Clinical Laboratory Management

World’s largest medical laboratory management conference will take place on April 26-27 and showcase how innovative labs are delivering more value with lab testing services

By now, most pathologists and clinical laboratory professionals recognize that healthcare is prepared to accept the use of whole human genome sequencing for diagnostic and therapeutic purposes. It is no longer a question of “will it happen?” Rather, the questions are now: “how fast will this happen and what must my lab do to be ready to support physicians in how they use the knowledge derived from whole human genome sequencing?”

Both of these questions will be answered by two globally-respected experts in the rapidly-advancing field of genetic medicine on April 26-27, 2016, at the 21st annual Executive War College on Laboratory and Pathology Management. (more…)

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