TAG:
clinical tests
In PAMA Appeal, ACLA Says Federal District Court Erred
LAST MONTH the American Clinical Laboratory Association (ACLA) filed an appeal in its case against the federal Department of Health and Human Services (HHS). In its court filing, the ACLA said that a federal district court judge erred in her ruling against the lab as…
Court Dismisses ACLA Claims in PAMA Case
CEO SUMMARY: While acknowledging that the American Clinical Laboratory Association raises important questions in its case against the federal Department of Health and Human Services, a district court judge ruled that the court cannot resolve the dispute and dismissed the ACLA’s claims f…
FDA Issues Response to Draft Legislation to Regulate LDTs
DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA…
Theranos News Gets Worse for the Former Silicon Valley Hero
CEO SUMMARY: In a tale of two fraudsters, the Department of Justice has filed a warning shot to all technology startups: Criminal indictments against Elizabeth Holmes and Ramesh “Sunny” Balwani could mean prison time and massive fines. In this latest Theranos news, The DOJ ci…
Holmes, Balwani Indicted by Department of Justice
CEO SUMMARY: Federal criminal indictments were unsealed last Friday in San Francisco against Elizabeth Holmes and Ramesh “Sunny” Balwani for their actions as executives at Theranos, Inc., the once high-flying lab test company. Officials at the Department of Justice said the counts aga…
Invitae Investing Heavily To Expand Market Share
CEO SUMMARY: In its first five years of offering clinical tests, Invitae has outspent revenue by $330.7 million. Yet its executives are confident that their company is on a path to becoming one of the dominant players in the genetic testing sector. This profile of Invitae will help pathol…
Proposed Bill in Congress Would Regulate LDTs
CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both …
Genetic Testing Lab Finds Payers Respond To Education on Test Utility
CEO SUMMARY: In recent years, insurers have raised the bar and become much tougher when making coverage and reimbursement decisions for molecular assays, genomic, and genetic tests. Yet several lab testing companies are having good success at demonstrating the validity and clinical utilit…
2015’s Top 10 Lab Stories Show Significant Changes
CEO SUMMARY: During 2015, two stories captured the full attention of most pathologists and clinical lab managers. One was how CMS intends to gather lab price market data as mandated by PAMA. The other was the continued efforts by the FDA to move ahead on proposed guidance for regulation o…
Coming Next Year for Labs: PAMA, FDA, LDTs, and More
CEO SUMMARY: As 2016 approaches, nearly every lab organization is watching and waiting to learn how federal regulators at CMS and the FDA will move forward with plans to implement PAMA market reporting and regulation of laboratory-developed tests, respectively. Most knowledgeable observer…
CURRENT ISSUE
Volume XXXI, No. 13 – September 23, 2024
The Dark Report has visited several companies in Europe to see what innovations they have developed that might be coming to laboratories and pathology groups in the U.S. Also, hospital lab outreach businesses are still valuable commodities in the eyes of the Blood Brothers. In addition, The Dark Report delivers the 2nd quarter earnings reports of the top global IVD companies.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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