Skip to main content
Premium Trial:

Request an Annual Quote

Exact Sciences to Meet with Medicare Reviewers on Cancer Test Coverage

NEW YORK (GenomeWeb News) – Exact Sciences will meet next week with officials from the Centers for Medicare and Medicaid Services to discuss the status of CMS’ review of the firm’s colorectal cancer screening technology, the company said today.
 
The company applied last August for a national coverage determination with CMS to try to get the stool-based CRC diagnostic covered under Medicare, but in October it was notified by the US Food and Drug Administration that the PreGen-Plus assay would require premarket approval.
 
"We have advised CMS of the status of our discussions with the FDA and, in an effort to preserve our future opportunity for a positive coverage decision, we requested that it consider not proceeding with the NCD until the FDA has acted," Exact Sciences President Jeffrey Luber said in a statement.
 
“We look forward to meeting with CMS to better understand its likely approach while we pursue FDA clearance for our DNA-based colorectal cancer screening technology," he added.
 
In October, the FDA’s Office of In Vitro Diagnostics Device Evaluation and Safety told Exact Sciences that it would need to review the PreGen-Plus because it deemed the test to be a medical device that required oversight and approval.
 
Exact Sciences did not provide an update today on the FDA’s review and company officials were not immediately available for comment.

The Scan

Researchers Compare WGS, Exome Sequencing-Based Mendelian Disease Diagnosis

Investigators find a diagnostic edge for whole-genome sequencing, while highlighting the cost advantages and improving diagnostic rate of exome sequencing in EJHG.

Researchers Retrace Key Mutations in Reassorted H1N1 Swine Flu Virus With Avian-Like Features

Mutations in the acidic polymerase-coding gene boost the pathogenicity and transmissibility of Eurasian avian-like H1N1 swine influenza viruses, a PNAS paper finds.

Genome Sequences Reveal Evolutionary History of South America's Canids

An analysis in PNAS of South American canid species' genomes offers a look at their evolutionary history, as well as their relationships and adaptations.

Lung Cancer Response to Checkpoint Inhibitors Reflected in Circulating Tumor DNA

In non-small cell lung cancer patients, researchers find in JCO Precision Oncology that survival benefits after immune checkpoint blockade coincide with a dip in ctDNA levels.