Increasing Revenue

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

Makers of innovative medical devices makers will remain on pins and needles after CMS’s decision to once more delay a final rule that would automatically provide initial Medicare coverage for new … [Read more...]

Increasing Revenue

New Colorectal Cancer Screening Guidelines Are a Windfall for Exact Sciences, Cologuard

If you held stock in Exact Sciences on May 17, chances are you went to bed happy on May 18. It was on May 18 that a U.S. government taskforce officially announced a change in its guidelines for … [Read more...]

FDA Watch

Agency Okays COVID-19 Blood Spot Self-Collection & Molecular Test Pooling

Pandemic pressures continue to produce unprecedented action from the FDA. The current imperative is to clear assays and collection kits for rapid and easy screening, including products that can be … [Read more...]

M&A Report

Thermo Fisher, Siemens Healthineers and DiaSorin Headline a Super Dynamic Month in Deal Making

After a prolonged pandemic-induced lull, M&A deal making in the diagnostics market continued its resurgence in April. Here’s a review of what was clearly the most dynamic month in M&A since … [Read more...]

DX Deals

Eurofins Teams with Uber for Home Delivery of COVID-19 Test Kits

At-home COVID-19 testing and sample collection is becoming so big that it’s drawing players from outside the lab testing market. And it’s not just the Walgreens, Walmarts, Amazons and other retailers … [Read more...]

DTC

Big Retail Chains Set to Roll Out Over-the-Counter COVID-19 Tests

DIY at-home COVID-19 testing using over-the-counter (OTC) test kits that don’t require a prescription is likely to become the new norm. With that clearly in mind, three of the country’s largest … [Read more...]

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...]

FDA Watch

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...]


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