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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
At-Home Testing Company Cor Crowdfunding for Commercialization
From - Diagnostic Testing & Emerging Technologies
At-home testing company Cor (San Francisco) has taken to online crowdfunding to commercialize its blood chemistry device. As of April 6, the company had pledges on…
New AMP Report Analyzes Costs, Value of Genomic Sequencing
From - National Intelligence Report
At a time when data on cost and clinical outcomes are in high demand yet short supply, the Association for Molecular Pathology (AMP, Bethesda, Md.) is taking an in-depth look at the…
CMS Scrutiny Continues for Theranos
From - Laboratory Industry Report
The Targeted Agent and Profiling Utilization Registry (TAPUR) study began recruiting its first patients last month. The trial, the first clinical trial undertaken by …
TAPUR Study Launches to Evaluate Off-Label Uses of Targeted Cancer Therapies
From - Diagnostic Testing & Emerging Technologies
The Targeted Agent and Profiling Utilization Registry (TAPUR) study began recruiting its first patients last month. The trial, the first clinical trial undertaken by …
At Lab Revolution, a Call for Changing the ‘Rules of Engagement’
From - Laboratory Industry Report
Gone are the days of isolated entities and closed systems within the American healthcare industry. And as once discrete services come to extend across the…
Specimen Collection and Handling Threatens Integrity of Diagnostics and Biomedical Research
From - National Intelligence Report
The massive amounts of data being created by diagnostics and the challenges and opportunities this data presents was the focus of…
LabCorp Purchases Outreach Business of Los Angeles-Area Hospital
From - Laboratory Industry Report
LabCorp has purchased the outreach laboratory business of a Los Angeles-area community hospital. Henry Mayo Newhall Hospital announced…
Theranos Appoints Scientific and Advisory Medical Board
From - Laboratory Industry Report
Theranos, which continues to come under fire regarding the viability of its testing platform, has just named an eight-member scientific and advisory medical board that contains luminaries from…
Survey Reveals Cybersecurity and Social Media as Top Compliance Concerns
Cybersecurity is a top compliance concern according to a survey of compliance professionals conducted by Health Care Compliance Association (HCCA) and the Society of Corporate Compliance and Ethics (SCCE). In January 2016, HCCA and SCCE surveyed 900 individuals,...
AACC Adds to List of Alternative LDT Oversight Proposals
Another industry trade group has chimed in on the issue of the U.S. Food and Drug Administration (FDA) regarding its intent to regulate laboratory developed tests (LDTs). The American Association of Clinical Chemistry (AACC) issued a position paper urging the FDA...