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EXAS Gains FDA Nod for Cologuard Plus, Progresses With CRC Screening
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Exact Sciences (EXAS - Free Report) recently received FDA approval for its next-generation multitarget stool DNA test, Cologuard Plus. This marks a significant advancement for the company in the field of colorectal cancer (CRC) screening.
This approval solidifies the company's leadership in the non-invasive cancer diagnostics space, offering a more accurate tool to combat one of the most preventable, yet often overlooked, cancers in the United States.
EXAS' Cologuard Plus Raises the Bar in CRC Screening
The FDA approval was based on findings from the pivotal BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening.
Per the findings, the Cologuard Plus test stands out for its high sensitivity—95% for colorectal cancer and 43% for advanced precancerous lesions—at a specificity of 94%. These statistics surpass its earlier generation, the Cologuard test, and elevate the performance of non-invasive testing.
In comparison to traditional methods like fecal immunochemical tests (FIT), the Cologuard Plus test has demonstrated significantly improved cancer detection rates across treatable stages, including high-grade dysplasia and advanced precancers. By reducing the rate of false positives by over 30%, the test aims to decrease unnecessary follow-up colonoscopies, an essential benefit for patients and healthcare systems alike.
Cologuard Plus Proves Superior Level of Early Detection for EXAS
Early detection remains crucial in the fight against CRC, the second deadliest cancer in the United States. The performance of Cologuard Plus makes it an essential tool for first-line screening in average-risk adults aged 45 and older.
The pivotal BLUE-C study emphasized the test’s combination of high sensitivity and low false-positive rates, ensuring that more patients are accurately diagnosed early when treatment options are most effective.
Path to Widespread Adoption
Expected to be launched in 2025 with Medicare coverage and inclusion in U.S. Preventive Services Taskforce guidelines, the Cologuard Plus test is poised to become a cornerstone of CRC screening. Supported by Exact Sciences’ innovative ExactNexus platform, the test will be integrated into over 350 health systems, ensuring wide accessibility and seamless implementation.
This latest FDA approval represents a pivotal moment in advancing colorectal cancer treatment, with the Cologuard Plus test setting a new benchmark for accuracy, ease of use and patient outcomes.
Market Prospects in Favor of EXAS
Going by a Future Market Insights report, the global cancer diagnostics market is poised for significant growth, with a projected CAGR of 8.5% from 2023 to 2033. Key factors driving this expansion include technological advancements in diagnostic tools, improved imaging techniques, and innovations in equipment that enhance accuracy in detecting various types of cancer. Early detection, particularly for common cancers, is vital for improving treatment outcomes, fueling demand for more efficient and accessible diagnostic solutions.
Other Peers of EXAS in the Cancer Screening Space
The company’s major competitor, Myriad Genetics (MYGN - Free Report) has so far made significant progress with its five strategic imperatives, which include transitioning and expanding the hereditary cancer market, diversifying revenues by commercializing its new products, increasing the company’s international contribution by investing in large countries, gaining reimbursement for new products, increasing international RNA kit revenues and enhancing profitability.
As a leader in genetic testing and precision medicine, Myriad Genetics provides insights that help people take control of their health and enable healthcare providers to detect, treat, and prevent disease better. The company believes that the key opportunities to grow its Oncology business are expanding companion diagnostics, expanding the market through new clinical guidelines and providing new offerings.
In the second quarter of 2024, hereditary cancer testing revenues from the oncology business rose 11% year over year. The growth reflects the company’s ongoing efforts to improve average revenue per test by expanding payer coverage and improving revenue cycle processes, which are helping reduce the no-pay rate. The acquisition of Intermountain Precision Genomics broadened its oncology testing options, bringing Precise Tumor and Precise Liquid tests in-house.
Another major peer, Veracyte (VCYT - Free Report) , is a global diagnostics company that provides clinicians with valuable insights into diagnosing and treating cancer. The company offers a wide array of advanced genomic tests that leverage deep scientific, clinical and machine learning expertise and other capabilities. Presently, the portfolio includes Afirma (for thyroid cancer), Decipher Prostate (prostate cancer), Prosigna (breast cancer), Envisia (interstitial lung diseases) and Decipher Bladder (bladder cancer), with additional tests in development.
These high-performing tests improve diagnostic, prognostic and treatment decisions in cancer and other challenging diseases, helping patients avoid unnecessary procedures and reducing time in finding appropriate treatment. In the United States, Veracyte offers tests through its central laboratories and makes them accessible to patients worldwide by collaborating with local labs.
Illumina (ILMN - Free Report) is another important competitor of EXAS in this line. Illumina’s expanding NGS oncology portfolio is helping the company drive the revolution in cancer genomics. Over the years, the company has developed multiple pharma partnerships to bring custom panel tests to market. Even as others enter the market, Illumina boasts confidence in remaining the key player, taking strength from the two-and-a-half-decade-long built infrastructure, compelling offerings that set the global standard, and a deep commitment to innovation for the future. Within this, the company’s recent partnership with Labcorp focuses on the benefits of comprehensive biomarker testing for patients across different cancer types to improve access to the latest genomic testing for community oncology physicians.
Reimbursement for NGS-based oncology testing also improved in 2023, with Anthem and Blue Cross Blue Shield, including CGP for advanced cancer patients, adding more than 30 million covered lives in the United States. Switzerland, too, initiated reimbursement for large next-generation sequencing panels, including CGP. Meanwhile, Illumina’s market-leading TruSight Oncology assay, TSO 500, is witnessing increased utilization and broader adoption.
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EXAS Gains FDA Nod for Cologuard Plus, Progresses With CRC Screening
Exact Sciences (EXAS - Free Report) recently received FDA approval for its next-generation multitarget stool DNA test, Cologuard Plus. This marks a significant advancement for the company in the field of colorectal cancer (CRC) screening.
This approval solidifies the company's leadership in the non-invasive cancer diagnostics space, offering a more accurate tool to combat one of the most preventable, yet often overlooked, cancers in the United States.
EXAS' Cologuard Plus Raises the Bar in CRC Screening
The FDA approval was based on findings from the pivotal BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening.
Per the findings, the Cologuard Plus test stands out for its high sensitivity—95% for colorectal cancer and 43% for advanced precancerous lesions—at a specificity of 94%. These statistics surpass its earlier generation, the Cologuard test, and elevate the performance of non-invasive testing.
In comparison to traditional methods like fecal immunochemical tests (FIT), the Cologuard Plus test has demonstrated significantly improved cancer detection rates across treatable stages, including high-grade dysplasia and advanced precancers. By reducing the rate of false positives by over 30%, the test aims to decrease unnecessary follow-up colonoscopies, an essential benefit for patients and healthcare systems alike.
Cologuard Plus Proves Superior Level of Early Detection for EXAS
Early detection remains crucial in the fight against CRC, the second deadliest cancer in the United States. The performance of Cologuard Plus makes it an essential tool for first-line screening in average-risk adults aged 45 and older.
The pivotal BLUE-C study emphasized the test’s combination of high sensitivity and low false-positive rates, ensuring that more patients are accurately diagnosed early when treatment options are most effective.
Path to Widespread Adoption
Expected to be launched in 2025 with Medicare coverage and inclusion in U.S. Preventive Services Taskforce guidelines, the Cologuard Plus test is poised to become a cornerstone of CRC screening. Supported by Exact Sciences’ innovative ExactNexus platform, the test will be integrated into over 350 health systems, ensuring wide accessibility and seamless implementation.
This latest FDA approval represents a pivotal moment in advancing colorectal cancer treatment, with the Cologuard Plus test setting a new benchmark for accuracy, ease of use and patient outcomes.
Market Prospects in Favor of EXAS
Going by a Future Market Insights report, the global cancer diagnostics market is poised for significant growth, with a projected CAGR of 8.5% from 2023 to 2033. Key factors driving this expansion include technological advancements in diagnostic tools, improved imaging techniques, and innovations in equipment that enhance accuracy in detecting various types of cancer. Early detection, particularly for common cancers, is vital for improving treatment outcomes, fueling demand for more efficient and accessible diagnostic solutions.
Other Peers of EXAS in the Cancer Screening Space
The company’s major competitor, Myriad Genetics (MYGN - Free Report) has so far made significant progress with its five strategic imperatives, which include transitioning and expanding the hereditary cancer market, diversifying revenues by commercializing its new products, increasing the company’s international contribution by investing in large countries, gaining reimbursement for new products, increasing international RNA kit revenues and enhancing profitability.
As a leader in genetic testing and precision medicine, Myriad Genetics provides insights that help people take control of their health and enable healthcare providers to detect, treat, and prevent disease better. The company believes that the key opportunities to grow its Oncology business are expanding companion diagnostics, expanding the market through new clinical guidelines and providing new offerings.
In the second quarter of 2024, hereditary cancer testing revenues from the oncology business rose 11% year over year. The growth reflects the company’s ongoing efforts to improve average revenue per test by expanding payer coverage and improving revenue cycle processes, which are helping reduce the no-pay rate. The acquisition of Intermountain Precision Genomics broadened its oncology testing options, bringing Precise Tumor and Precise Liquid tests in-house.
Another major peer, Veracyte (VCYT - Free Report) , is a global diagnostics company that provides clinicians with valuable insights into diagnosing and treating cancer. The company offers a wide array of advanced genomic tests that leverage deep scientific, clinical and machine learning expertise and other capabilities. Presently, the portfolio includes Afirma (for thyroid cancer), Decipher Prostate (prostate cancer), Prosigna (breast cancer), Envisia (interstitial lung diseases) and Decipher Bladder (bladder cancer), with additional tests in development.
These high-performing tests improve diagnostic, prognostic and treatment decisions in cancer and other challenging diseases, helping patients avoid unnecessary procedures and reducing time in finding appropriate treatment. In the United States, Veracyte offers tests through its central laboratories and makes them accessible to patients worldwide by collaborating with local labs.
Illumina (ILMN - Free Report) is another important competitor of EXAS in this line. Illumina’s expanding NGS oncology portfolio is helping the company drive the revolution in cancer genomics. Over the years, the company has developed multiple pharma partnerships to bring custom panel tests to market. Even as others enter the market, Illumina boasts confidence in remaining the key player, taking strength from the two-and-a-half-decade-long built infrastructure, compelling offerings that set the global standard, and a deep commitment to innovation for the future. Within this, the company’s recent partnership with Labcorp focuses on the benefits of comprehensive biomarker testing for patients across different cancer types to improve access to the latest genomic testing for community oncology physicians.
Reimbursement for NGS-based oncology testing also improved in 2023, with Anthem and Blue Cross Blue Shield, including CGP for advanced cancer patients, adding more than 30 million covered lives in the United States. Switzerland, too, initiated reimbursement for large next-generation sequencing panels, including CGP. Meanwhile, Illumina’s market-leading TruSight Oncology assay, TSO 500, is witnessing increased utilization and broader adoption.