in vitro diagnostic Archives

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Passage of FDA Regulation of LDTs Inches Closer in the Senate

By Robert Michel | From the Volume XXIX, No. 8 – June 6, 2022 Issue

CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA regulatory oversight of LDTs. …

IVD Firms Report Boom in Sales of COVID-19 Instruments, Tests

By Robert Michel | From the Volume XXVII, No. 11 – August 3, 2020 Issue

Because of the COVID-19 pandemic, second quarter earnings reports were a good news/bad news situation for most of the nation’s major in vitro diagnostic (IVD) companies. The good news was that demand for COVID-19 tests meant increased sales and revenues for IVD firms selling those…

FDA Clears Aperio’s Digital Pathology System

By Joseph Burns | From the Volume XXVI No. 10 – July 22, 2019 Issue

CEO SUMMARY: In May, the FDA announced clearance for Leica Biosystems to market its Aperio AT2 DX System for clinical diagnosis in the United States. The Aperio AT2 DX System is intended for in vitro diagnostic use as an aid to pathologists reviewing and interpreting digital images of sur…

Biggest IVD Manufacturers Report Robust Third Quarter Earnings

By Robert Michel | From the Volume XXV No. 15 – October 22, 2018 Issue

In a time of shrinking lab budgets and falling prices for lab tests in the United States, how are the larger in vitro diagnostic (IVD) manufacturers doing? A look at third-quarter financial reports provides useful insights as to which segments within the IVD industry are doing better than ot…

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…

July 30, 2018 Intelligence: Late Breaking Lab News

By Robert Michel | From the Volume XXV No. 11 – July 30, 2018 Issue

Clinical labs and physicians can soon say goodbye to “meaningful use.” Federal officials are proposing a significant change to the Medicare and Medicaid EHR Incentive program for certified EHRs that has been in existence since 2011. In a press release issued last spring, the Centers for M…

Response to FDA’s Gottlieb on Reducing Regulatory Burden

By Joseph Burns | From the Volume XXV No. 6 – April 16, 2018 Issue

IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He …

FDA’s Gottlieb Favors Flexibility with LDTs, NGS

By Joseph Burns | From the Volume XXV No. 5 – March 26, 2018 Issue

CEO SUMMARY: FDA Commissioner Scott Gottlieb said the FDA wants to reduce the regulatory burden on developers of next-generation sequencing (NGS) and laboratory-developed tests (LTDs). He also wants to give the FDA more flexibility in how it conducts clinical analysis and validation. To d…

Newsmaker Interview: Healthcare’s Transformation Now Bringing Changes to Lab Industry

By Joseph Burns | From the Volume XXV No. 3 – February 12, 2018 Issue

“Today, patients want to get diagnosis and treatment faster with fewer visits to the doctor’s office. They want speedier and more comprehensive delivery of clinical services, be it laboratory tests, imaging, or other procedures.” …

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