NEW YORK – Exact Sciences' share price rose as much as 11 percent by mid-Tuesday afternoon following news that its next-generation Cologuard Plus test was priced at approximately $592 by the US Centers for Medicare and Medicaid Services — 16 percent higher than the original Cologuard test.
Shares of Exact Sciences closed on Tuesday up 9 percent on the Nasdaq, and in early trading on Wednesday morning, its stock price rose about 2 percent.
In its final 2025 Clinical Laboratory Fee Schedule released on Monday, CMS priced the test at a higher rate than the original Cologuard assay after the centers had preliminarily priced the new assay at the same rate as the original test. Cologuard is currently priced at approximately $508.
Exact Sciences originally sought a price of about $635, or 1.25 times Cologuard's rate, but that decision was voted down by a Medicare advisory panel earlier this year, Cowen analyst Dan Brennan said in a note to investors.
Cologuard Plus received approval from the US Food and Drug Administration last month, and Exact Sciences has said it expects to launch the test commercially in either Q1 or Q2 2025.
In a note to investors, BTIG analyst Mark Massaro wrote that although most investors expected some price increase for Cologuard Plus, "the actual amount and mechanism of the increase was uncertain," and the resolution of that uncertainty "helps to derisk the stock." He added that Medicare's fee-for-service population, which would be subject to the clinical laboratory fee schedule (CLFS) price for Cologuard Plus, is about 15 to 20 percent of the Cologuard test population.
Massaro said that according to Exact Sciences, the firm requested the price increase after the public comment period through a new proposed framework that used the established pricing of testing for Septin 9 ($192) times three plus a FIT test ($15) to arrive at the final $592 price.
Brennan noted that Septin 9 is a blood-based colorectal cancer screening test based on methylation in the SEPT9 gene. Cologuard Plus includes three methylated genes (LASS4, LRRC4, and PPP2R5C).
CMS said on the CLFS document that it agrees with that combination of codes and believes the combination "adequately describes the new version of this test, instead of simply using a multiplier to estimate an increase of resources."
The new prices laid out in the CLFS will go live on Jan. 1, 2025.
Vijay Kumar, an analyst with Evercore ISI, said in a note to investors that he believes a 10 percent average price increase for the test from commercial payors is possible.