TAG:

FDA

VALID and SALSA Acts Still Pending in Congress

CEO SUMMARY: Both the pending VALID Act and SALSA Act continue to push ahead as 2022 comes to an end. Meanwhile, a new bill centered on the Physician Fee Schedule may protect pathologist payments. These three different proposals share something in common:…

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Newsmaker Interview: Director of CDC’s Division of Laboratory Systems Talks COVID-19, CLIA, and More

CEO SUMMARY: In this exclusive interview, Reynolds Salerno, PhD, the Director of the Division of Laboratory Systems at the CDC, offers insightful comments about the federal agency’s response to the SARS-CoV-2 pandemic, what went right during public health efforts, and lesson…

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How Genomic Testing Labs Can Improve Their Relationships with Payers

CEO SUMMARY: For payers and health plans, it may be a matter of trust that initially curtails speedy reimbursement of new and novel genomic test claims. A panel …

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Might LDT Regulation Bill Support Be Waning in Congress?

This is an excerpt of an 833-word article in the July 18, 2022 issue of  THE DARK REPORT. The full article is available to members of The Dark Intelligence Group.   …

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Important Court Rulings & Pending New Federal Law 

IMPORTANT THINGS ARE HAPPENING WITH COURT DECISIONS AND PROPOSED FEDERAL LEGISLATION that will affect a substantial number of the nation’s clinical laboratories and anatomic pathology groups. In this issue of The Dark Report, you’ll be alerted to those developments we th…

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Might VALID Act Support Be Waning in Congress?

CEO SUMMARY: Just weeks ago, events seemed to indicate that the Verifying Accurate Lea…

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In Post-COVID-19 Market, IVD Manufacturers Face Supply, Staff Challenges

CEO SUMMARY: After making billions during the COVID-19 pandemic, in vitro diagnostics (IVD) manufacturers must now adjust their strategies and relationships with clinical laboratory customers. Because many contracts for automated instruments are coming due, some IVD companies have t…

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Halfway Through 2022, More Changes Come at Labs

APPROACHING THE MIDWAY MARK OF 2022, some clinical laboratory directors and pathologists might feel like they’ve already experienced enough changes to last the whole year.  For example, since the start of 2022, we’ve seen SARS-CoV-2 testing surges co…

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Passage of FDA Regulation of LDTs Inches Closer in the Senate

CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA regulatory oversight of LDTs. …

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January 31, 2022 Intelligence: Late-Breaking Lab News

DNA-based breast cancer testing is taking a step forward. Illumina in San Diego, which sells next-generation sequencing (NGS) technology, announced a partnership with Agendia in Irvine, Calif., to develop in vitro diagnostic tests for oncology. Agendia offers proprietary breast …

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