EnVISION Non-Invasive Prenatal® Screening

Understand Non-invasive Prenatal Test (NIPT) and Understand NIPT Results

Advancements in genetic testing have revolutionized the detection of fetal chromosomal abnormalities, utilizing the analysis of cell-free DNA (cfDNA) derived from the fetal placenta in maternal blood.

Guideline Recommendations

Recent updates to the clinical management guidelines from the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) unequivocally endorse Non-Invasive Prenatal Testing (NIPT) as the most sensitive and specific screening method for detecting common fetal aneuploidies. These guidelines recommend offering prenatal screening for fetal chromosomal abnormalities to all pregnant patients, regardless of age or other risk factors.

When discussing prenatal screening options with your patients, you may consider presenting the following three approaches:

No prenatal genetic testing: Patients may choose to forgo genetic testing during pregnancy or defer testing until after birth.
Prenatal genetic testing: If NIPT results indicate an increased risk for a genetic condition, follow-up diagnostic testing, such as chorionic villus sampling (CVS) or amniocentesis, may be recommended.
Direct diagnostic testing: Some patients may opt to bypass NIPT and proceed directly with diagnostic procedures like CVS or amniocentesis.

Non-Invasive Prenatal Testing (NIPT) or Cell-Free DNA Screening

NIPT is an optional blood test that can be performed at any time after 10 weeks of gestation. This screening method provides valuable information on the likelihood or risk of the developing fetus having:

Down syndrome (Trisomy 21)
Edwards Syndrome (Trisomy 18)
Patau Syndrome (Trisomy 13)
Sex chromosome aneuploidy disorders
Genetic conditions associated with copy number changes, such as 22q11.2 deletion syndrome

Additionally, NIPT can determine fetal sex in most cases, should the patient wish to know.

RhVISION Fetal RhD typing using non-invasive cfDNA is provided for RhD negative pregnant patients.

EnVISION Non-Invasive Prenatal® Screening

EnVISION Prenatal® Screening is a major advance in prenatal testing based on genome deep sequencing. It is a non-invasive screening test (NIPT) that enables assessment of over or under representation of chromosomes from maternal whole blood samples. The test is developed by Otogenetics using Illumina VeriSeq NIPT Solution with the VeriSeq Assay Software. The validated NIPT screening test provides the information for chromosomes 21, 18, 13, X and Y with increased risks for trisomy 21, 18, 13 and sex chromosome aneuploidies reported. Gender information is available for reporting. The test reports for both singleton and twin pregnancies. 22q11.2 microdeletions can be selected for analysis and reporting for singleton pregnancies.

EnVISION Prenatal® Screening has the lowest redraw rate and not-resulted rate. The redraw rate is 0.64%, the lowest in the industry. In addition, 87.5% of the redraws are resulted. The overall not-resulted rate is 0.08%, the lowest in the industry.

FAQ's Billing & Insurance FAQs

Every patient should have access to highly accurate and affordable genetic testing. Otogenetics is committed to work with each patient to reach payment solutions. These may include:

Working with your insurance provider to verify coverage.
Flexible payment options billed over several months.
Financial assistance for patients who qualify.

We encourage patients to call us for all billing questions, and to discuss payment solutions.

Please call us toll free at 1-855-686-4363, option 1.

Otogenetics is committed to working with patients to ensure that everyone has access to testing without financial burden.

Medicaid patients will NOT have patient out of pocket responsibility.
We treat all out-of-network claims as if they are in-network.
We will work with all insurers (primary and secondary policies) to maximize your qualified coverage.

Otogenetics testing service is covered by many insurance plans, the exact amount your patients owe may vary based on their individual plan and financial situation.

Here is our commitment to your patients regarding costs:

We will reach out to your patient if we estimate their cost could be more than $50 (the average out of pocket Otogenetics patients pay).
We will discuss the estimate with your patients, and review their affordability.

Your patient may receive information from their insurer, known as an Explanation of Benefits (EOB), regarding the test they received from Otogenetics.

An EOB from your patient’s insurer is NOT A BILL.

A bill for the test(s) provided by Otogenetics comes ONLY from Otogenetics.

If there is any patient out of pocket cost after Otogenetics has exhausted all options for reimbursement coverage and financial assistance, Otogenetics will reach out to your patient.