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ClariTestTM Non-Invasive Prenatal Screening

ClariTestTM is a non-invasive prenatal screen (NIPS) which harnesses the power of massively parallel sequencing to screen for fetal chromosomal abnormalities. ClariTestTM can be performed as early as 10 weeks of gestation from a simple blood draw. It exhibits outstanding sensitivity and specificity for the most common trisomies and specific microdeletion syndromes.

GenPath Offers Two ClariTest™ Options

ClariTest™

  • Basic panel screens for common aneuploidies only
  • The chromosomes screened are 21 (Down syndrome), 18 (Trisomy 18), 13 (Trisomy 13), and X and Y (monosomy X, triple X syndrome (XXX), Klinefelter syndrome (XXY) and XYY syndrome)

ClariTest™ With Microdeletions

  • This panel screens for common aneuploidies as well as five microdeletions
  • The chromosomes screened are 21 (Down syndrome), 18 (Trisomy 18), 13 (Trisomy 13), and X and Y (monosomy X, triple X syndrome (XXX), Klinefelter syndrome (XXY) and XYY syndrome)
  • Microdeletions assessed are 22q11.2 deletion (DiGeorge syndrome), 1p36 deletion syndrome, 5p- syndrome (Cri-du-chat syndrome), 15q11.2 deletion (Prader-Willi syndrome/Angelman syndrome), and 4p- syndrome (Wolf-Hirschhorn syndrome).
  • Collectively these microdeletions can affect 1 in 1,000 pregnancies and have clinical features that affect growth, intellectual ability, and/or development

View Conditions Screened for with ClariTest Non-invasive Prenatal Screen with Microdeletions

Available To A Broad Patient Population

ClariTestTM is a safe option without the risks associated with invasive procedures such as chorionic villus sampling (CVS) and amniocentesis. It can be used to screen for common aneuploidies for both singleton and twin gestations. Microdeletion screening is available for singleton gestations.

Clear, Accurate Reporting

Results for chromosomes 21, 18, 13 and sex chromosomes are reported as:

  • No Aneuploidy Detected
  • Aneuploidy Detected

Results for microdeletions are reported as:

  • No Microdeletions Detected
  • Abnormality Detected

A patient-specific positive predictive value (PPV) is provided for Aneuploidy Detected results for Down syndrome (Trisomy 21), Trisomy 18, and Trisomy 13.

ClariTestTM is a screening test only. Patients receiving an “Aneuploidy Detected” or “Abnormality Detected” result are advised to seek genetic counseling, as well as discuss diagnostic testing options. Decisions regarding the pregnancy should NOT be made based on ClariTestTM results only.

Bringing Clarity To Your Patients

Other NIPS technologies result in a greater rate of no-calls (test failures), which may cause patient anxiety and may result in unnecessary invasive procedures. ClariTest TM utilizes proven next generation sequencing (NGS) technology to provide accurate NIPS results for patients.

ClariTest offers:

  • High sensitivity and specificity
  • Results within 5-7 days
  • Fewer no calls and redraws than other NIPS methodologies

ClariTest TM has the lowest test failures in the industry. Fewer test failures may result in:

  • Reduced patient anxiety
  • Less repeat testing
  • Confidence in results the first time
  • Fewer unnecessary invasive procedures

Genetic Counseling Support

Every patient that receives ClariTest from GenPath has the option of scheduling an in-depth counseling session with a MyGeneTeam genetic counselor. Learn more about Genetic Counseling through MyGeneTeam here.