Future regulation of laboratory-developed tests (LDTs) may not be as clear as it once appeared. On Sept. 30, Congress passed a short-term resolution to keep the federal government funded. As part of the move, a proposed bill to increase oversight of LDTs has been sidelined, at least for now, according to law firm Ropes & Gray based in Boston. The Verifying Accurate Leading-edge IVCT Development Act of 2022 (VALID Act) seeks to move approval of LDTs to the Food and Drug Administration. Currently, LDTs are regulated under the Clinical Laboratory Improvement Amendments Act of 1988. Federal lawmakers have discussed versions of the VALID Act since 2021. At one point the legislation seemed a sure bet to pass.
MORE ON: VALID Act
The congressional spending resolution expires on Dec. 16, but it remains to be seen whether the VALID Act will be part of any subsequent add-ons to future funding activity, Ropes & Gray reported. The Act and other policy proposals “will likely receive renewed attention as members of Congress come back to the negotiating table in an attempt to move forward with further legislation later this year,” the law firm noted.
GOOGLE CLOUD LAUNCHES DIGITAL SUITE FOR MEDICAL IMAGING
Google Imaging is making a foray into digital imaging for medical diagnostics. Fierce Healthcare wrote “Google Cloud’s Medical Imaging Suite will include cloud-based file storage using international imaging standards and secure data exchanges.” This will be a “web-based picture archiving system for radiologists.” It is known that Google is working to apply imaging solutions to pathology specimens.
• Beckman Coulter Diagnostics named Karan Arora as Senior VP of Marketing, Strategy, and Product Insights. He previously served in high-level roles at AstraZeneca, Abbott, Pfizer, and Novartis.
• Dominic Weilbaecher is the new Vice President of Payer Relations at Babson Diagnostics. He worked in reimbursement roles for AI biomarker firm Mindera and genomic testing company Agendia. He previously spent 14 years at Quest Diagnostics.
• David Vinson is the new Senior Vice President for Diagnostic Laboratory Services at Vanderbilt University Medical Center. He had been serving as Interim Vice President on a contract basis for the past 15 months. Previously he worked in pathology operations for Med Fusion and Specialty Laboratories.
• Peter Manes is now Area Sales Manager at CompuGroup Medical US. He previously served at Ortho Clinical Diagnostics, Cerner, Labotix, and Abbott Laboratories.
That’s all the insider intelligence for this report. Look for the next briefing on Monday, October 31, 2022.