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Search Results for: Theranos CLIA

Theranos Won’t Discuss Disruptive Lab Technology

Clinical Laboratory / By Joseph Burns

CEO SUMMARY: In a partnership with Walgreens pharmacies, Theranos Inc. announced that it will run clinical lab tests on “micro-samples” and collect these blood samples without venipuncture. Even as Theranos touts the patient-friendly benefits of its proprietary diagnostic technology, it has provided no information about the science that supports this testing and the clinical validations …

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The Dark Report Interviews the CDC’s Reynolds Salerno, PhD

TDR Insider / By Robert Michel

Reynolds Salerno, PhD, had a front row view into the federal government’s response, both to the SARS-CoV-2 pandemic and the recent monkeypox outbreak. As Director of the Division of Laboratory Systems (DLS) at the U.S. Centers for Disease Control and Prevention (CDC), Salerno played an instrumental role in how diagnostic testing was provided during recent public health emergencies. In …

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How Labs Can Improve Their Relationships with Payers for Genomic Test Reimbursement

TDR Insider / By Robert Michel

This is an excerpt of a 2,215-word article in the October 10, 2022 issue of THE DARK REPORT. The full article is available to subscribers. CEO SUMMARY: For payers and health plans, it may be a matter of trust that initially ensures new and novel genomic test reimbursement. A panel of experts at the Executive War College offered insights on effective …

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How Genomic Testing Labs Can Improve Their Relationships with Payers

Genetic Testing, Laboratory Billing, Molecular Diagnostics / By Robert Michel

CEO SUMMARY: For payers and health plans, it may be a matter of trust that initially curtails speedy reimbursement of new and novel genomic test claims. A panel of experts at the Executive War College offered insights on effective ways that genetic testing laboratories can establish that trust early on with payers. From there, clinical labs must then navigate obstacles while effectively demonstrating the value to patients of genomic tests …

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California Agency Problems Deepened Valencia Branch Laboratory Saga

Laboratory Compliance / By Robert Michel

CEO SUMMARY: Adding a new twist in the ongoing saga of the CLIA compliance failures at the Valencia Branch Laboratory in California are insights from a former clinical laboratory director familiar with the industry in California. He observed that problems at California’s Laboratory Field Services (LFS) office are known to the state legislature, following an …

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2021’s Top 10 Lab Stories Confirm Important Trends

Clinical Laboratory Trends / By Robert Michel

CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab industry stories for 2021. Beyond COVID-19 testing, the virus crept its way into long-term trends, such as pathology jobs and technology innovation. New ways of delivering healthcare will need responses by clinical laboratories, as will significant developments in the …

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Pathologist Makes News at Elizabeth Holmes Trial

Clinical Laboratory / By Robert Michel

CEO SUMMARY: During the trial, a pathologist who formerly was CLIA lab director at Theranos testified about the little regard Theranos executives had for federal proficiency testing regulations labs must follow to retain their CLIA license. Another point of contention was how this pathologist had sent himself copies of emails to document management decisions designed …

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September 27, 2021 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

Following the opening of her criminal trial in a Silicon Valley courtroom in recent weeks, Elizabeth Holmes—the disgraced ex-Founder and CEO of Theranos—continues to be the subject of news headlines. Federal prosecutors are calling witnesses to testify. Much of this testimony includes anecodotes and facts about her personal life and the way she made business …

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April 24, 2017 Intelligence: Late Breaking Lab News

Late Breaking Lab News / By Robert Michel

Theranos, Inc., is again in the news. On April 17, the company disclosed a global settlement with the federal Centers for Medicare & Medicaid Services (CMS) to resolve “all outstanding legal and regulatory proceedings between CMS and Theranos.” The company said, pursuant to terms of the settlement, CMS withdrew revocation of the company’s CLIA operating …

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February 21, 2017 Intelligence: Late Breaking Lab News

Late Breaking Lab News / By Robert Michel

Theranos, Inc., was in the news again recently. On Feb. 16, The Wall Street Journal reported that Theranos had just $200 million in cash. The information came from a conference call the discredited lab testing company conducted with its investors. During the call, Theranos officials also stated that the company had no material revenue during …

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