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Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
DX Earnings Report: PAMA Cuts Make Little Dent on Q1 Lab Earnings
From - National Intelligence Report
One quarter into its existence, the new PAMA Medicare Part B fee schedule seems to be having only a marginal impact on at least publicly traded labs. In fact, the recently published…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Agilent, Bio-Techne and Mission Bio were among the producers launching multiple products. Here's a rundown of the key diagnostic product launches from…
Expanded Carrier Screening IDs Rare Variants in Diverse Populations
From - Diagnostic Testing & Emerging Technologies
Expanded next-generation sequencing-based carrier screening improves detection of rare and novel pathogenic variants even in…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: The feds accused a Missouri lab of submitting false claims to Medicare for travel fees in transporting specimens from April 2011 to December 2014. In addition…
Enforcement Trends: Private Insurers Are Cracking Down on the Labs that Scam Them
From - National Intelligence Report
Once the almost exclusive domain of federal law enforcers and inside whistleblowers, the lucrative industry of going after labs for improper billing has…
Current Testing Criteria Miss Breast Cancer Mutations
From - Diagnostic Testing & Emerging Technologies
Women who do not meet breast cancer genetic testing criteria have a similar number of cancer-associated mutations as women who do meet the criteria…