TAG:
clinical tests
In PAMA Appeal, ACLA Says Federal District Court Erred
By Joseph Burns | From the Volume XXVI No. 1 – January 14, 2019 Issue
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
By Joseph Burns | From the Volume XXV No. 14 – October 1, 2018 Issue
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
By Joseph Burns | From the Volume XXV No. 12 – August 20, 2018 Issue
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
By R. Lewis Dark | From the Volume XXV No. 9 – June 18, 2018 Issue
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
By Joseph Burns | From the Volume XXV No. 9 – June 18, 2018 Issue
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
By Robert Michel | From the Volume XXIV No. 12 – August 28, 2017 Issue
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
By Joseph Burns | From the Volume XXIV No. 7 – May 15, 2017 Issue
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
By Joseph Burns | From the Volume XXIII No. 8 – June 13, 2016 Issue
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
By Robert Michel | From the Volume XXII, Number 18 – December 28, 2015 Issue
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
By Robert Michel | From the Volume XXII, Number 17 – December 7, 2015 Issue
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. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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