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The Galleri test is a qualitative, sequencing-based, in vitro diagnostic test used to detect DNA methylation patterns using cell-free DNA isolated from human peripheral whole blood. Certain DNA methylation patterns can serve as a signal of cancer and provide information about the origin of the cancer signal.
The Galleri test should be used in addition to guideline-recommended cancer screening, such as mammography, colonoscopy, prostate specific antigen (PSA) or cervical cancer screening. Galleri can benefit patients with an elevated risk of cancer due to age, such as those aged 50 or older.
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing.
The Galleri test is intended for clinical purposes. The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict the tissue type or organ associated with the cancer signal to help your healthcare provider determine next steps.
When it comes to cancer, early detection is key to saving lives! With 610,000+ cancer deaths in the U.S. each year, most of which stemming from cancer types with no FDA-approved screening options, EPISEEK is making revolutionary strides in detecting cancers that have been previously undetectable in early stages.
The EPISEEK liquid biopsy blood test is intended to be used as a complementary tool to established cancer screening assessments. However in some cases, especially for cancer types that have no previously established screening test and are notoriously hard to detect, it may be the only warning sign currently available for providers.
What cancers does it detect?
Precision Epigenomics Liquid Biopsy Test is designed to detect the presence of the most prevalent lethal solid tumors including lung cancer, breast cancer, prostate cancer, colorectal cancer, pancreatic cancer, head and neck cancer, urinary bladder cancer, and esophageal cancer. Further bioinformatic analysis showed the loci have high sensitivity and specificity for cervical squamous cell carcinoma, endo cervical adenocarcinoma, bile duct carcinoma (cholangiocarcinoma), DLBC lymphoma, glioma, liver hepatocellular carcinoma, mesothelioma, gastric adenocarcinoma, uterine endometrial carcinoma, and uterine carcinosarcoma. It’s important to note that the test may have limited sensitivity in early-stage cancers and should not be considered are placement for routine cancer screening such as colonoscopy, mammogram, and cervical cancer screening.
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