Dx Deals: Illumina to Acquire SomaLogic from Standard BioTools for $425M
The deal is expected to be a big boost for Illumina’s next-generation sequencing platforms
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Articles and Reports
FDA Watch: Agency Launches Database of Complete Response Letters Sent to Drug Manufacturers About Initial Rejections
The early focus is on drug applications, but it could spread to the laboratory test approval process as well
Federal Appellate Decision on EKRA Spells Out How Lab Marketers Can Violate the Law
If clinical lab managers instruct marketing personnel to engage in kickback practices, they also could be held legally accountable
Lab Marketing & Staffing: 4 Common Kickback Pitfalls to Avoid
How laboratories can avoid compliance issues involving certain marketing and staffing practices.
Expert Q&A: How Technology is Improving Access to Lab Testing
Healthcare leader Steve Serota discusses a new partnership and how it is bringing high-quality lab testing to underserved areas.
Laboratory Relocation: 6 Common Pitfalls to Avoid
Missing small details or getting them wrong can be disastrous for a lab move—here’s how to avoid major issues.
Dx Deal Roundup: A Major Proteomics Merger, Ginkgo Makes Pharma Inroads, and More Legal Woes for Illumina
As is usual at this time of year, deals in the diagnostics industry were up, both in terms of volume and value.
FDA Watch: Simplifying and Speeding Up 510(k) Authorization
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
November 2023 Labs in Court
This month’s roundup of cases includes Walgreens’ settlement with Theranos customers, kickbacks, and age discrimination.
Compliance Perspectives: When Do Cybersecurity Donations Violate Kickback Laws?
The compliance risks of giving referral sources software or equipment to ensure the security of protected health information.
Compliance Tool: Model Policy on Donating Cybersecurity Technology to Physicians
This template aims to help lab leaders develop a policy for donations of cybersecurity technology that complies with safe harbor requirements.
FDA Proposal for LDTs Risks Serious Consequences
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.
FDA Watch: What Labs Need to Know About New Medical Device Cybersecurity Rules
As of October 1, medical device makers must include information about their products’ vulnerabilities when seeking premarket authorization.
