Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
New Patient Guidelines Released for Breast Cancer Screening and Diagnosis
The new guidelines offer patients advice on when they should start their screening, and how often they should have it done.
FDA Watch: New Guidance on Charging for Investigational Drugs
On August 21, the FDA proposed new guidelines on charging for investigational drugs; here are the key highlights.
Final Surprise Billing Rules Seek to Provide Fairer Price Dispute Resolution
Revised final rule essentially disarms the threat of insurers having the advantage in out-of-network price disputes.
Labcorp Continues Its Outreach Labs Buying Spree
While the overall M&A market has been slow in 2022, Labcorp has been on a bit of an acquisitions binge.
Amazon Ends Telehealth Services, but Forges Ahead with Healthcare Disruption
In a surprise move, the e-retail giant announced it will close down its Amazon Care Primary Health Services for employees at the end of 2022.
CMS Proposes Significant Increases to CLIA Fees
While the rule is not yet final, it’s likely that labs will have to pay more in direct CLIA compliance expenses, starting in October.
FDA Extends Shelf Life of At-Home Rapid COVID-19 Tests
Users should realize that the FDA can extend the shelf life of a test when and if it receives additional data supporting such an extension.
FY 2022 Q2 Earnings Trend Down, but Much Less than Predicted
While not nearly as robust as a year ago, diagnostic companies’ revenues held up surprisingly well in Q2 2022.
Is an Antibody Test for Early Detection of Lyme Disease Feasible?
Recent study suggests a new test may help doctors detect Lyme disease during the early stages when treatment is likely to be more effective.
Pancreatic Cancer Is Caught Sooner When Regular Screening Done
A recent study shows that most patients who underwent such screening were diagnosed at an earlier stage than those who did not.
