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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Global News: EU Delays Launch of Eudamed Database
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PAMA Report: ACLA Tries for Decisive Blow in Federal Court Case
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ACLA Goes for Knockout Punch in PAMA Lawsuit
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Medicare Reimbursement: CMS Eases Coverage Restrictions on NGS Testing of Early-Stage Cancer Patients
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Lab Fails in Bid to Get Medicare Payment Suspension Set Aside
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Diagnostic Deals: A roundup of the key mergers, acquisitions, alliances, licenses and other strategic transactions from the past month
Although briskness in alliances partially offset sluggishness in M&A, October was far less dynamic than September for strategic deal making within the diagnostics sector. Here’s an overview of the key deals that did come down over the 4-week period beginning in late September 2019.
FDA Watch: New Process for Simultaneous Review IVD Tests Used in Cancer Drug Trials
Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, the FDA issued final guidance allowing companies to submit for simultaneous review for the clinical trial.
The DX Pipeline: A roundup of the month’s key new product launches
With 10 days still left to run, October was shaping up to be the busiest month of 2019 for new product launches. Here’s a summary of the key diagnostic products unveiled so far:
Federal Court Dismisses Urine Drug Test False Billing Claim
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Enforcement Trends: New Takedown Is Evidence that Genetic Testing Has Become an Enforcement Priority
It’s a pretty good sign that fraudulent billing of genetic lab testing has become a priority for federal fraud enforcers when it gets its very own “takedown.”