Industry Buzz

Antitrust Regulators Derail Plans for Illumina-Grail Cancer Genomics Powerhouse

You could almost hear the gasp from the cancer genomics market when Illumina announced plans to shell out $8 billion--$3.5 billion in cash and $4.5 billion in common shares—to re-acquire Grail, the … [Read more...]

CPT Coding

AMA Creates New PLA Code 0247U for Sera Prognostics PreTRM Test

The most recent laboratory developed test (LDT) to garner CPT code recognition from the American Medical Association (AMA) is Sera Prognostics, Inc.’s PreTRM Test, a proteomic blood test for measuring … [Read more...]

Labs in Court

Massachusetts Mental Health Hospital Fined $65,000 for HIPAA Right of Access Violation

Case: The HIPAA Privacy Rule gives providers 30 days and, in some instances, 60 days to respond to patients’ requests of access to their medical records. But it took Massachusetts behavioral health … [Read more...]

Genetic Testing

AMP Survey Finds that Inadequate Reimbursement Hinders Use of Molecular Diagnostics

Inadequate reimbursement is hindering utilization of molecular testing. That is the conclusion of a new survey from the Association of Molecular Pathology (AMP). Survey respondents also suggested that … [Read more...]

FDA Watch

First De Novo Clearance Signals that Premarket Pathway Is Open for COVID-19 Tests

Just over a year ago, the U.S. Food and Drug Administration (FDA) granted its first Emergency Use Authorization (EUA) for a coronavirus test. On March 17, 2021, the test review process moved to a new … [Read more...]

FDA Watcha

Agency Opens Premarket Pathway for Post-Emergency COVID-19 Test Marketing

The public health emergency that began last February will eventually end. But the demand for COVID-19 tests will not. The transition from the emergency to post-emergency test market unofficially began … [Read more...]

DX Deals

Abbott Lands $255 Million Rapid COVID-19 Antigen Test Pentagon Contract

In invoking the Defense Production Act (DPA), the Biden Administration has authorized the federal government to mobilize private industry in the war against coronavirus. The administration is also … [Read more...]

Genetic Testing

New Study Supports Use of Liquid Biopsy Technology to Bolster MRI Accuracy in Cancer Treatment

Important new evidence has emerged supporting the capabilities of liquid biopsy to enhance the accuracy of magnetic resonance imaging (MRI) for cancer diagnosis and treatment. That evidence comes from … [Read more...]

Increasing Revenue

Manufacturers Wait Anxiously for CMS Decision on Automatic Medicare Coverage of MCIT Breakthrough Devices

Manufacturers of innovative medical devices are on pins and needles right now that the Center for Medicare and Medicaid Services (CMS) has delayed implementation of a final rule that was supposed to … [Read more...]

PAMA

MedPAC Explores Simplified PAMA Reporting to Cut Burdens & Restore Lab Prices

The upcoming report of the Medicare Payment Advisory Commission (MedPAC) gives the lab industry new hopes for relief from the administrative burdens of Protecting Access to Medicare Act of 2014 (PAMA) … [Read more...]


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