Exact Sciences Corp - EXAS STOCK NEWS

Exact Sciences Corp. (NASDAQ: EXAS) announced FDA approval for its Cologuard Plus™ test, a next-generation multitarget stool DNA test for colorectal cancer (CRC) screening. The test is approved for adults 45 and older at average risk for CRC. Key highlights:

1. 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity
2. Significantly outperformed fecal immunochemical test (FIT) in various sensitivity measures
3. Expected launch in 2025 with Medicare coverage and guideline inclusion
4. Builds on success of original Cologuard test, used over 17 million times

The company aims to improve CRC screening rates and outcomes by detecting cancer early and finding advanced precancers.

Exact Sciences Corp. (NASDAQ: EXAS) presented performance data for its blood-based colorectal cancer (CRC) screening test at the ESMO Congress. The test showed sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at 90.1% specificity. The study included over 3,000 blood samples, with most from the BLUE-C study.

The company aims to close the screening gap through innovation, combining a novel panel of markers. BLUE-C results are now expected in the first half of 2025, which will support an FDA submission. If approved, this test could provide another option for 60 million unscreened people in the US.

Exact Sciences also presented data on its multi-cancer early detection (MCED) blood test, showing 54.8% sensitivity at 98.5% specificity for cancers without standard screening options, and 63.7% for six aggressive cancers.

Exact Sciences Corp. (Nasdaq: EXAS), a leading cancer screening and diagnostic test provider, has announced its participation in two upcoming investor conferences. The company will be present at the Wells Fargo Healthcare Conference in Boston on September 4, 2024, with a fireside chat scheduled for 3:45 p.m. ET. Additionally, Exact Sciences will participate in the Baird Global Healthcare Conference in New York on September 11, 2024, with a fireside chat at 10:15 a.m. ET.

Investors are invited to join the webcasts of these events, which will be accessible through the investor relations section of Exact Sciences' website at www.exactsciences.com. These conferences provide an opportunity for the company to engage with investors and share insights into its operations and future prospects in the healthcare sector.

Exact Sciences Corp. (Nasdaq: EXAS) has initiated its Multi-Cancer Early Detection (MCED) Falcon Registry Real-World Evidence study, enrolling the first patient at Baylor Scott & White Health in Texas. The study aims to enroll up to 25,000 patients aged 50-80 with no cancer history, evaluating the clinical performance and impact of MCED testing over a five-year period. Endeavor Health in Illinois will also participate, starting enrollments this fall.

The study, authorized by the FDA under an investigational device exemption, will provide insights for developing Exact Sciences' future MCED test. Participants will undergo annual MCED testing for three years, followed by two years of follow-up data collection. The test combines two high-performing biomarker classes to detect cancer early, potentially addressing the gap in existing screening programs and aligning with the U.S. government's Cancer Moonshot initiative to reduce cancer mortality by 50% over 25 years.

Exact Sciences Corp. (Nasdaq: EXAS) has shared new modeling data on the impact of their Cologuard test for colorectal cancer (CRC) screening over the past decade. The data reveals that:

- Over 16 million Cologuard screenings have been completed
- 525,000 people with advanced precancerous lesions were detected
- 80% of cancers detected were early-stage
- An estimated $22 billion in healthcare costs have been saved

The Cologuard test has contributed significantly to increasing CRC screening rates from 63% in 2015 to 72% in 2021 among Americans ages 50-75. It has also tripled screening rates for ages 45-49 from 2021 to 2023. Exact Sciences is currently awaiting FDA review for their next-generation Cologuard test, aiming to further improve CRC screening accuracy and accessibility.

TwinStrand Biosciences and Exact Sciences (Nasdaq: EXAS) have announced an exclusive license agreement for TwinStrand's Duplex Sequencing technology in the cell-free nucleic acid sequencing space. This technology enhances next-generation sequencing accuracy by up to 10,000 times, enabling detection of ultra-low frequency mutations.

The agreement grants Exact Sciences the right to use, commercialize, and sublicense the intellectual property, which includes patent portfolios from the University of Washington and the University of Texas Southwestern. Exact Sciences' rights are broadly exclusive for cell-free nucleic acid sequencing, with some non-exclusive exceptions.

This partnership aims to accelerate advancements in early cancer detection and precision oncology, potentially leading to more precise and reliable cancer diagnostic solutions for patients and healthcare providers worldwide.

Exact Sciences Corp. (EXAS) reported strong Q2 2024 results, with total revenue of $699 million, up 12% year-over-year. Screening revenue increased 15% to $532 million, while Precision Oncology revenue grew 7% to $168 million. The company screened over 1 million people with Cologuard for the first time in a quarter. Despite the revenue growth, Exact Sciences reported a net loss of $16 million, or $0.09 per share, which is an improvement from the previous year. Adjusted EBITDA rose to $110 million, with a margin of 16%. The company maintained its full-year 2024 revenue guidance and raised its adjusted EBITDA guidance midpoint by $8 million.

Imperative Care, a medical technology company focused on stroke and ischemic diseases, has announced the initial closing of an oversubscribed Series E financing led by Ally Bridge Group. The financing, which may raise up to $150 million in total, includes participation from existing and new investors. The funds will support the company's hypergrowth strategy and investment in novel technologies and clinical evidence.

Additionally, Shacey Petrovic has been appointed to the newly created position of Vice Chair of the Board of Directors. Petrovic, who joined the board in 2023, will focus on scaling strategies to bring life-changing technologies to more patients. She previously served as President and CEO of Insulet and currently sits on the boards of Exact Sciences (EXAS), Ambu A/S, and Axena Health.

Exact Sciences, a leading cancer screening and diagnostic tests provider, will release its second quarter 2024 financial results after U.S. market close on July 31, 2024.

A webcast and conference call to discuss these results is scheduled for 5 p.m. ET the same day. The webcast will be accessible on the company's website, with domestic and international dial-in options available. A replay will also be offered on the website.