Exact Sciences Gets FDA Nod For Label Expansion Of Cologuard

Exact Sciences Corp. (NASDAQ:EXAS) announced that the FDA has approved a label expansion of its noninvasive colorectal cancer screening test, Cologuard.

The test can now be used in eligible average-risk individuals aged 45 years or older, expanding on its previous indication for 50 years or older.

As a result of the broader label, approximately 19-million average-risk people in the United States from the age group of 45-49 years can now access a new, sensitive, at-home, stool-based screening test.

Cologuard is a stool DNA-based colorectal cancer screening test for average-risk individuals. The test uses a biomarker panel, which analyzes a person's stool sample for 10 DNA markers, as well as blood in the stool.

We note that the FDA approved Cologuard for the first time in August 2014. Colorectal cancer is the second deadliest cancer in the United States and an early screening will go a long way in better management of the disease.

Given the widespread prevalence of colorectal cancer among Americans under 50 years, the expanded label bodes well for molecular diagnostics company, Exact Sciences. Notably, in May 2018, the American Cancer Society (ACS) updated its colorectal cancer screening guidelines to include people between 45 years and 49 years, while the prior ACS recommendation called for screening to begin at age 50.

The news of the approval boosted the company’s stock price, which eventually retraced by the end of the day.

In July, Exact Sciences announced that it will acquire Genomic Health, Inc. (NASDAQ:GHDX) for $2.8 billion, thereby creating a leading global cancer diagnostics company. The combined company will offer two of the strongest and fastest-growing brands in cancer diagnostics — Cologuard and Oncotype DX.

We remind investors that Exact Sciences also has a promotion agreement with Pfizer, Inc. (NYSE:PFE) , whereby the latter will promote Cologuard and provide certain sales, marketing, analytical and other commercial operations support services.

Meanwhile, Guardant Health, Inc. (NASDAQ:GH) is evaluating LUNAR RUO assay to identify early-stage colorectal cancer patients with post-operative molecular residual disease, who may benefit from adjuvant therapy.

Exact Sciences currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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