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INDICATIONS FOR USE

ColoHealth Direct™ is a laboratory developed test (LDT) for the detection of methylated SEPT9 (mSEPT9) DNA in blood plasma. Methylated SEPT9 is a biomarker associated with colorectal cancer and has been studied as a blood-based marker for colorectal cancer detection and screening.

ColoHealth Direct™ is intended to aid in colorectal cancer screening and assessment. The test may provide a blood-based screening option for individuals seeking additional information regarding colorectal cancer risk and may be considered in conjunction with an individual's age, medical history, family history, symptoms, risk factors, and other relevant clinical information.

Published research has evaluated methylated SEPT9 in a variety of populations, including individuals younger than age 50 and individuals with increased risk for colorectal cancer. Clinical performance may vary among populations, and test results should be interpreted in the context of the individual's overall clinical circumstances.

WARNINGS, LIMITATIONS & PRECAUTIONS

ColoHealth Direct™ is a laboratory developed test developed and performed by New Day Diagnostics in a CLIA-certified laboratory. The test has not been cleared or approved by the U.S. Food and Drug Administration (FDA).

A positive ColoHealth Direct™ result does not establish a diagnosis of colorectal cancer. Individuals with a positive result should receive appropriate clinical evaluation and follow-up, which may include diagnostic colonoscopy.

A negative ColoHealth Direct™ result does not rule out colorectal cancer, precancerous lesions, or other colorectal disease. Individuals with symptoms, significant risk factors, or other clinical concerns should consult an appropriate healthcare professional regardless of the test result.

ColoHealth Direct™ should not be used as a substitute for diagnostic evaluation or colonoscopy when such evaluation is clinically indicated. Test results should be considered together with medical history, family history, clinical findings, and other relevant information.

Clinical performance has not been established for every age group, risk category, medical condition, or clinical circumstance.

REFERENCES

Loomans-Kropp HA, Song Y, Gala M, Parikh AR, Van Seventer EE, Alvarez R, Hitchins MP, Shoemaker RH, Umar A. Methylated Septin9 (mSEPT9): A promising blood-based biomarker for the detection and screening of early-onset colorectal cancer. Cancer Res Commun. 2022;2(2):90-98.

Song L, Jia J, Peng X, et al. The performance of the SEPT9 gene methylation assay and a comparison with other CRC screening tests: A meta-analysis. Sci Rep. 2017;7:3032.

Hitchins MP, Vogelaar IP, Brennan K, et al. Methylated SEPTIN9 plasma test for colorectal cancer detection may be applicable to Lynch syndrome. BMJ Open Gastroenterol. 2019;6.

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ColoHealth Direct™

ColoHealth Direct™

$299.00