Top Articles

Revised Stark and AKS Rules Are Good News for Labs

Federal regulators wanted to incorporate common definitions into both sets of regulations

CEO SUMMARY: It must be rewarding for federal rulemakers at the Centers for Medicare and Medicaid Services and the Office of the Inspector General to hear that attorneys representing clinical labs and pathology groups consider the new final rules for the Stark Law and the Anti-Kickb...

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Understanding Key Parts of New AKS, Stark Law Rules

Certain revisions to both final federal rules should help clinical laboratories with compliance

CEO SUMMARY: Both the federal Stark Law and Anti-Kickback Statute have been revised and the final rules became effective on Jan. 19. The good news for clinical laboratories and anatomic pathology groups is that federal regulators from the Centers for Medicare and Medicaid Services a...

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IVD & IT Update Roche to Acquire GenMark, Ovation.io Raises $21.5M

Roche to Pay $1.8 Billion for GenMark  THERE'S MORE CONSOLIDATION in the in vitro diagnostics (IVD) industry. It was announced on Mar. 15 that Roche Diagnostics would acquire GenMa...

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What Comes Next? Predictions on COVID-19 Test Volumes in 2021-22

Some public lab companies have good insights

CEO SUMMARY: Incoming data show that the number of referrals for both COVID-19 tests and routine tests is in a decline that started in October and is continuing. This complicates the strategic planning for hospital/health system labs, independent labs, and pathology groups. They nee...

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IVD Update Truvian Sciences Raises $105M for Near-Patient Lab Test System

San Diego company hopes to obtain FDA clearance for its multi-analyte analyzer that uses drops of blood

DESPITE THE PANDEMIC, investors continue to support emerging in vitro diagnostics (IVD) companies. This is particularly true of start-up companies that want to develop clinical lab testing systems that can be used at the point of care, that require small amounts of blood, and that deliver accu...

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Despite COVID-19, Regular Lab Testing Expands

TIMES ARE GOOD FOR THE REGULAR RANGE of clinical laboratory and anatomic pathology testing services. Despite the COVID-19 pandemic, the daily number of routine test specimens is near pre-pandemic levels and certain sectors of lab testing—particularly genetic tests and some high-cost assays—are showing substantial growth this year, compared to 2019....

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