Theranos Whistleblowers to Give Fireside Chat at AACC 2022
Erika Cheung and Tyler Shultz—two of the key Theranos whistleblowers—will speak in a special fireside chat at AACC 2022.
Erika Cheung and Tyler Shultz—two of the key Theranos whistleblowers—will speak in a special fireside chat at AACC 2022.
COLA’s Waived Testing Toolkit provides guidance and tools to help staff achieve and maintain waived testing excellence, including guidance on covid-19 reporting.
The changes make it easier to navigate to questions by topic.
The virtual laboratory survey process consists of three parts: documentation, review, and a video conference.
Read MoreThe template will help developers submit EUA requests for covid-19 diagnostics that can be performed entirely in settings such as homes, offices, or schools.
Read MoreOn July 29, the FDA will host a virtual Town Hall for clinical labs and commercial manufacturers involved in developing diagnostic tests for SARS-CoV-2.
Read MoreThe updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data and provide new recommendations.
Read MoreAI-driven software can help labs expertly navigate the prior authorization landscape.
Read MoreIf the agency’s proposed reclassification is finalized, devices of this type may go through the 510(k) pathway for clearance instead of the premarket approval (PMA) pathway.
Read MoreThe waiver will provide temporary relief from federal regulations requiring pathologists to render primary diagnoses onsite at healthcare facilities.
Read MoreCMS has issued a change request to inform Medicare administrative contractors about new HCPCS codes that are subject to and excluded from CLIA edits.
Read MoreFinal rules require access to health information, spur innovation, and aim to end information blocking.
Read MoreFDA and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 products.
Read MoreFDA has recently issued two guidance documents for developers of in vitro diagnostics.
Read MoreIllumina has filed two additional patent infringement suits relating to BGI’s sequencing products. Related patent suits are pending in Denmark, Germany, Switzerland, Turkey and the United States.
Read MoreThe Cloud-based solution automates the analysis of next-generation sequencing data for liquid biopsy and FFPE workflows.
Read MoreAMP President Victoria M. Pratt, PhD, discusses the association’s updated position statement on consumer genomic testing.
Read MoreNow is the time to make sure that hospital executives are fully educated about details of the Protecting Access to Medicare Act of 2014.
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