Trial Enrollment Over Indexes in Traditionally Under-Represented Black Community
ST. LOUIS /PRNewswire/ — Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced completed enrollment of the CRC-PREVENT pivotal trial for its noninvasive, at-home diagnostic screening test to detect colorectal cancer (CRC) and advanced adenomas in average-risk individuals. Through a decentralized recruitment strategy, Geneoscopy enrolled more than 14,000 individuals across all 48 continental United States, many from traditionally under-represented communities in clinical trials, in terms of gender, race, ethnicity, socioeconomic status, and geography.
Geneoscopy enrolled 14,000+ individuals, many from traditionally under-represented communities in clinical trials.Tweet
Of the participants:
- More than a quarter were racial or ethnic minorities
- 16% were Black or African American – an over-index proportionally based on:
- Just 5% of U.S. clinical trial participants are Black1
- 12% of the U.S. population is Black or African American2
- 3% were Asian
- 7% were Hispanic or Latino
- 16% were Black or African American – an over-index proportionally based on:
According to the American Cancer Society, CRC disproportionately affects the Black community, where the incidence and mortality rates are the highest of any racial/ethnic group in the U.S. In fact, Black people are about 20 percent more likely to be diagnosed with CRC and about 40 percent more likely to die from CRC than most other groups.
“Too often, underserved communities face barriers that exclude them from participating in important clinical trials. Our decentralized recruitment strategy helped mitigate these challenges, resulting in a diverse group of participants that are representative of the individuals that may use our noninvasive CRC screening tool,” said Dr. Erica Barnell, Chief Science Officer and co-founder of Geneoscopy. “We were particularly encouraged to see a substantial number of Black participants in our trial. Unfortunately, these individuals have a greater chance of having and dying from CRC compared with other racial groups, and yet too often, are underrepresented in clinical research. We believe that basing advances in cancer screening and prevention on data from all Americans will build greater confidence in new screening tests and, ultimately, save more lives.”
Complete efficacy and enrollment findings from the trial will be presented later this year. These findings will support a Pre-market Approval application to the U.S. Food and Drug Administration by the end of 2022.
About Colorectal Cancer & Screening
Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer death in the United States. CRC usually begins as a growth (or polyp) that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, many newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold standard for CRC screening in the U.S., yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and associated discomfort, resulting in low patient compliance. Currently available noninvasive screening methods lack sufficient sensitivity to reliably detect both early-stage CRC and high-risk precancerous lesions, including advanced adenomas which are a precursor in up to 70 percent of CRC cases.
About Geneoscopy Inc.
Geneoscopy Inc. is a life sciences company focused on the development of diagnostic tests for gastrointestinal health. Geneoscopy’s lead diagnostic uses stool-derived eukaryotic RNA (seRNA) to detect colorectal cancer and precancerous adenomas. This device was awarded Breakthrough Device Designation from the U.S. FDA for its ability to reduce morbidity associated with colorectal cancer through advanced adenoma detection. Indicative of its breakthrough status, initial trials suggest that the diagnostic can detect these lesions at a higher rate than that demonstrated by all existing noninvasive screening tests in their respective studies. Visit geneoscopy.com to learn more.
Geneoscopy Inc. Forward-Looking Statements
The information contained in this release includes information about Geneoscopy’s future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, and as such constitute forward-looking statements. These forward-looking statements are based on the Company’s reasonable estimates of future results or trends. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control. Geneoscopy’s actual results and financial condition may differ materially from those indicated in the forward-looking statements. Although the Company believes that its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved, and the actual results may differ substantially from the projected results.
SOURCE Geneoscopy Inc.
Breast Cancer Awareness Month: Taking Action
Make a difference during Breast Cancer Awareness Month by taking action, supporting early detection, and accessing resources.
Breast Cancer Awareness Month (BCAM) is a significant time when pink ribbons symbolize the fight against breast cancer. However, it’s crucial to understand that awareness alone is not enough. This October, let’s go beyond awareness and take action.
A breast cancer diagnosis can be overwhelming, which is why initiatives like the NBCF Patient Navigation Program exist—to ensure that no one battles breast cancer alone. Early detection is key to successful outcomes, but many people may not know what signs and symptoms to look for. Thankfully, resources like NBCF’s “Most Asked Questions: Breast Cancer Signs & Symptoms” provide answers and guidance.
We can all make a difference during BCAM. Use your voice, passion, and financial support to ensure that every woman has access to critical screening, support, and care. By getting involved, getting screened, making a donation, or taking action, you can directly impact the lives of those affected by breast cancer.
Breast Cancer Awareness Month extends beyond awareness campaigns. In the United States, organizations like the National Football League incorporate pink into their activities, and even comic strip artists dedicate a day in October to raise awareness. Additionally, various walks and events raise funds for breast cancer programs, such as the iconic Race for the Cure, which began in October 1983.
Let’s make Breast Cancer Awareness Month a time of action, support, and empowerment. Together, we can make a difference and ensure that everyone facing breast cancer receives the care and resources they deserve.
If you would like to donate to BCAM or get more information, please follow this link:https://en.wikipedia.org/wiki/Breast_Cancer_Awareness_Month
FDA Grants First DNA Test for Dozens of Cancer Types
FDA grants marketing authorization for DNA test assessing predisposition for multiple cancer types.
The U.S. Food and Drug Administration (FDA) has recently made a groundbreaking announcement by granting the first marketing authorization for a DNA test that assesses predisposition for dozens of cancer types. This significant development comes in the form of the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test capable of detecting genetic variants associated with an elevated risk of developing certain cancers. This test marks a major advancement in personalized medicine, as it can evaluate DNA samples to identify variants in 47 genes known to be linked with an increased likelihood of developing specific types of cancer.
By utilizing next-generation sequencing technology, the Invitae Common Hereditary Cancers Panel offers a comprehensive assessment of multiple genes in a single test. This enables healthcare professionals to gain valuable insights into an individual’s genetic predisposition for certain cancers. With this information, physicians can provide appropriate monitoring and potential therapies tailored to each patient’s specific needs.
Cancer remains one of the leading causes of death in the United States, and the availability of this test brings a vital public health tool into the hands of medical professionals. It equips them with additional information to guide patient care, potentially leading to earlier detection and intervention for those at higher risk. However, it is important to note that this test does not evaluate all known cancer-related genes, and patients should consult with a healthcare professional to interpret the results accurately.
The Invitae Common Hereditary Cancers Panel underwent rigorous evaluation by the FDA under the De Novo premarket review pathway. Extensive testing, involving over 9,000 clinical samples, demonstrated an accuracy rate of ≥99.0% for all tested variant types. While the test carries the possibility of false positive and false negative results, the risks are mitigated by the analytical and clinical performance validation, along with appropriate labeling.
In addition to granting marketing authorization, the FDA has established special controls that define requirements related to labeling and performance testing. These measures ensure the safety and effectiveness of similar devices in the future, potentially expediting the regulatory process for subsequent tests.
The FDA’s decision to grant marketing authorization for the Invitae Common Hereditary Cancers Panel is a significant milestone in the field of genetic testing and personalized medicine. It offers individuals valuable information about their health, empowering them to make informed decisions regarding monitoring and potential therapies. As technology continues to advance, such tests have the potential to revolutionize cancer care by enabling earlier detection and personalized treatment strategies.
Read the press release here: https://www.fda.gov/news-events/press-announcements/fda-grants-first-marketing-authorization-dna-test-assess-predisposition-dozens-cancer-types?utm_medium=email&utm_source=govdelivery
FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies
FDA launches pilot program to accelerate rare disease therapies, improving communication between sponsors and FDA staff. #RareDiseaseTherapies #FDA #ClinicalTrials
In a significant move to expedite the development of novel drug and biological products for rare diseases, the U.S. Food and Drug Administration (FDA) has introduced a pilot program aimed at fostering more frequent communication between sponsors and FDA staff. This initiative, known as the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program, aims to address clinical development challenges and generate high-quality data to support the future marketing applications of potentially life-saving therapies.
Enhancing Communication and Collaboration:
Under the START Pilot Program, a limited number of sponsors will have the opportunity to obtain regular ad-hoc communication and advice from FDA staff. This communication will focus on addressing product-specific development issues such as clinical study design, selection of control groups, and fine-tuning the choice of patient population. By facilitating improved communication, the FDA aims to streamline the development process for rare disease therapies and ensure that patients with unmet medical needs receive timely access to innovative treatments.
Eligibility and Application Process:
The program is open to sponsors of products currently in clinical trials under an active Investigational New Drug application (IND) regulated by the Center for Biologics Evaluation and Research (CBER) and/or the Center for Drug Evaluation and Research (CDER). Eligibility criteria differ between CBER and CDER-regulated products. CBER-regulated products must be gene or cellular therapies addressing an unmet medical need for a rare disease likely to cause significant disability or death within the first decade of life. CDER-regulated products must be intended to treat rare neurodegenerative conditions, including rare genetic metabolic disorders. Detailed eligibility requirements can be found in the Federal Register Notice.
The Road Ahead:
The FDA plans to accept applications for the START program between January 2, 2024, and March 1, 2024. Participants will be selected based on their application readiness and ability to progress their development programs towards a marketing application. The agency will choose up to three participants for each center. After evaluating the pilot program and receiving feedback from selected sponsors, the FDA may consider a second iteration, which would be announced in the Federal Register at a later date.
Commitment to Rare Disease Therapies:
The FDA’s efforts to advance the development of therapies for rare diseases extend beyond the START Pilot Program. The agency has recently requested feedback from stakeholders on scientific challenges and opportunities related to cellular and gene therapies for rare diseases. This input will help inform the planning of future meetings, workshops, and educational programs to facilitate the development of regulatory tools and frameworks.
Additionally, the FDA has created the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) program under the CDER Accelerating Rare disease Cures (ARC) initiative. Stakeholder feedback gathered through this program will contribute to identifying knowledge gaps in rare disease drug development and the creation of publicly available resources to guide stakeholders in designing and conducting clinical trials.
The FDA’s launch of the START Pilot Program demonstrates its commitment to expediting the development of rare disease therapies. By facilitating enhanced communication and collaboration between sponsors and FDA staff, the program aims to accelerate the availability of potentially life-saving treatments for patients with unmet medical needs. This pilot program, along with other ongoing initiatives, highlights the FDA’s dedication to improving the regulatory framework and recommendations for rare disease product sponsors, ultimately ensuring the safety, effectiveness, and quality of these important therapies.
Read the press release: https://www.fda.gov/news-events/press-announcements/fda-launches-pilot-program-help-further-accelerate-development-rare-disease-therapies?utm_medium=email&utm_source=govdelivery
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