On Monday, Exact Sciences (NASDAQ:EXAS) stock received a reiterated Buy rating and an $82.00 price target from BTIG. The endorsement follows the recent approval by the FDA of Cologuard Plus, Exact Sciences' enhanced stool test for colorectal cancer screening.
The approval, which was anticipated by both the analyst firm and the broader market, was announced last Friday and came slightly ahead of expectations.
The upgraded Cologuard Plus test boasts improved accuracy over the original version, with sensitivity and specificity rates of 95% and 94%, respectively. These figures surpass the previously published rates of approximately 94% for sensitivity and 91% for specificity in the New England Journal of Medicine. The company plans to launch the new test in the first half of 2025, maintaining the previously communicated timeline.
Exact Sciences spoke to the analyst firm on Friday, confirming their intention to market Cologuard Plus with the higher accuracy rates. The company is also considering whether to apply for Advanced Diagnostic Laboratory Test (ADLT) status following the final Centers for Medicare & Medicaid Services (CMS) decision on Clinical Diagnostic Laboratory Tests (CDLTs) expected in November.
The analyst firm believes that pursuing ADLT status could be a beneficial strategy for Exact Sciences, potentially leading to a price increase with a higher likelihood than the CDLT pathway.
The discussion among investors regarding Exact Sciences has recently centered on the company's care gap orders expected in the second half of 2024. With the FDA approval serving as a positive development, BTIG has reaffirmed its confidence in the stock with a maintained Buy rating and price target.
In other recent news, Exact Sciences Corp. has seen a series of significant developments. The U.S. Food and Drug Administration (FDA) approved the company's Cologuard Plus test for colorectal cancer screening. This test, recognized for its improved accuracy, boasts a sensitivity of 95% and a specificity of 94%, and is expected to be commercially available in 2025.
Exact Sciences reported a year-over-year revenue increase of 12%, reaching $699 million in its second quarter earnings. This increase was primarily attributed to the use of its Cologuard test by over a million people and record global patient testing with Oncotype DX.
In the realm of analysts' perspectives, Leerink Partners reiterated an Outperform rating on Exact Sciences following the FDA approval. Other firms such as TD Cowen, Canaccord Genuity, BTIG, Citi, and Piper Sandler have maintained or raised their price targets for the company, largely maintaining a Buy rating.
Exact Sciences has also initiated the Falcon Registry study for Multi-Cancer Early Detection at Baylor Scott & White Health in Texas, aiming to enroll up to 25,000 participants. These are the recent developments for Exact Sciences Corporation.
InvestingPro Insights
To complement the positive outlook on Exact Sciences (NASDAQ:EXAS) following the FDA approval of Cologuard Plus, InvestingPro data offers additional financial context. The company's market capitalization stands at $12.63 billion, reflecting investor confidence in its growth potential. Exact Sciences has demonstrated strong revenue growth, with a 13.54% increase over the last twelve months, reaching $2.61 billion. This aligns with the company's innovative product developments and market expansion efforts.
InvestingPro Tips highlight that Exact Sciences has shown a strong return over the last three months, which correlates with the anticipation and subsequent approval of Cologuard Plus. Additionally, the company's liquid assets exceed short-term obligations, indicating a solid financial position to support the launch of the new test in 2025.
It's worth noting that while Exact Sciences is not currently profitable, the improved accuracy of Cologuard Plus and potential pricing strategies, such as pursuing ADLT status, could positively impact future earnings. Investors seeking a more comprehensive analysis can find 7 additional tips on InvestingPro, offering deeper insights into Exact Sciences' financial health and market position.
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