Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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
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
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
New Special Prosecutor to Crack Down on COVID-19 Relief Fraud
Weeks after the COVID-19 public health emergency was declared, Congress passed a pair of massive bills—the Families First Coronavirus Response Act (FFCRA) and Coronavirus Aid, Relief, and Economic Security Act (CARES)—providing trillions of dollars in relief for...
Certain Gut Microbes May Identify Pancreatic Cancer Sooner
A specific panel of gut microbes may identify pancreatic cancer, irrespective of how far the disease has progressed, suggests research published online in the journal Gut. The findings offer hope of a new non-invasive method of diagnosing this hard to treat...
The Latest Changes at G2 Intelligence
It’s been busy here at G2 Intelligence as we continue to make improvements to the brand. One change that you’ve likely noticed is that our four monthly briefings—National Lab Reporter, Diagnostic Testing & Emerging Technologies, Lab Compliance Advisor, and...
Labcorp and Walgreens Partner to Provide Free COVID-19 Test Kits
On March 7, global life science company Labcorp and major US retailer Walgreens announced that Labcorp’s Pixel by Labcorp® COVID-19 at-home collection kit will be available at Walgreens locations across the US for free to eligible individuals. The PCR test has...
COVID-19 Revenues Bubble Hasn’t Burst, But It Is Leaking
What a difference a year makes. In Q4 2021, COVID-19 testing demand was cresting and lab companies with COVID-19 products were posting record—and ultimately unsustainable—revenue growth. Compared to this baseline, 15 of the 31 companies that had reported their...
Blue Cross and Blue Shield of Minnesota Files Lawsuit Against GS Labs
EAGAN, MN — Blue Cross and Blue Shield of Minnesota (Blue Cross) announced on March 1 that it is taking legal action against COVID-19 testing laboratory GS Labs, LLC (GS Labs) to recover more than $10 million in overpayments made since the start of the pandemic....
Be ‘Recall Ready,’ FDA Urges Companies
SILVER SPRING, MD — On March 3, the U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take, before a recall is...
Labs in Court Weekly Roundup
Court cases involving the lab and health care industries from this past week and a half have centered mostly on fraud. In addition to those cases, a former doctor was charged for unlawfully distributing opioid pills and the U.S. Department of Justice (DOJ) and...
Liquid Biopsy Global Sales Expected to Hit $26.2 Billion by 2030
A new report projects that the worldwide market for liquid biopsy will grow from $7.1 billion in 2020 to $26.2 billion by 2030
New Microchip Could Lead To Home-Based Prostate Cancer Tests
Associate professor Kazuhiro Takahashi and Tomoya Maeda (a second-year master's student) and other members of the Department of Electrical and Electronic Information Engineering at Toyohashi University of Technology have developed a semiconductor sensor capable of...
