Ex-Theranos CEO Elizabeth Holmes Takes Witness Stand in Her Own Defense: Admits to Using Pharma Giants’ Logos on Reports to Investors, But Claims No Intent to Deceive

Former CEO also testified that she believed company’s proprietary blood-testing technology could perform ‘any’ clinical laboratory blood test One relevant question in the federal fraud trial of ex-Theranos CEO Elizabeth Holmes was whether she would testify on her own behalf. That question was answered shortly after the government rested its criminal fraud case against the former Silicon Valley clinical laboratory testing company founder. Holmes took the stand in her own defense, a risk her...

New CMS Proposed Rule Encourages Value-Based Reimbursement Based on Patient Outcomes When Payers and Drug Manufacturers Negotiate Payment for Pricey Therapies

Clinical laboratories and anatomic pathology groups should consider this another example of how CMS is taking forward steps to encourage value-based payment arrangements throughout the health system With the sky-high cost of many prescription drugs and gene therapies, it was only a matter of time before the Centers for Medicare and Medicaid Services (CMS) would seek to link reimbursement for them to patient outcomes. A recent CMS proposed rule (CMS-2842-P) concerning value-based purchasing...

FDA Approves Digital Therapeutics Technologies to Treat Patient Behavioral Conditions That Interfere with Positive Healthcare Outcomes

Clinical laboratories with strong digital and information technology capabilities may find opportunities in this growing field of healthcare Digital therapeutics (DTx), a growing trend in life sciences technology, is emerging as a popular form of connected healthcare physicians can use to transform patient behavior and improve clinical outcomes. This development may create opportunities for IT-savvy clinical laboratories. The software applications (apps) and hardware monitoring devices...

New Miniature Continuous Glucose Monitoring Devices from DexCom and Verily (Google Life Sciences) Promise to Make Glucose Monitoring Wearable and Affordable

Such a small, non-invasive glucose monitor would capture and transmit data to the Cloud, making it feasible for clinical laboratories to collect those tests results, and keep a record of each patient’s glucose results Probably no single area of medical laboratory testing has the greatest potential to help the largest number of patients with a chronic disease—and make a lot of money for the in vitro (IVD) manufacturer who is first to market with the right diagnostic product—than glucose testing...

Breakthrough DNA Editing Tool May Help Pathologists Develop New Diagnostic Approaches to Identify and Treat the Underlying Causes of Diseases at the Genetic Level

The advent of the CRISPR/Cas9 genetic editing tool is already generating novel therapies for diseases and will create new opportunities for pathologists and medical laboratories In just 24 months, a new gene-editing tool has become the hot topic worldwide among researchers working to understand DNA and develop ways to manipulate it for therapeutic purposes. It goes by the acronym CRISPR and it may soon become quite familiar to most pathologists and medical laboratory scientists. CRISPR stands...
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