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If you are a provider and do not yet have an account with us, please call us at 888-250-LUNA (5862) or email us at inquiries@lunagenetics.com.

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FAQs

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ANswers to common Questions

Frequently Asked Questions

Can I do the Luna SCPD test instead of CVS or amnio?

Yes, the Luna SCPD test is a diagnostic alternative to CVS or amniocentesis and provides similar information. The test can also be done much earlier than amniocentesis in your pregnancy, as early as eight weeks.

Are there risks involved with prenatal genetic tests?

The Luna SCPD test is based on a standard blood draw and is therefore noninvasive and considered to be without risk. CVS and amniocentesis are invasive procedures that are not without risks. Pregnancy loss attributed to CVS is approximately 1 in 455 on the most recent estimates. Pregnancy loss attributed to amniocentesis is approximately 1 in 900. (Source: 2. Akolekar R, Beta J, Picciarelli G, et al. Procedure-related risk of miscarriage following amniocentesis and chorionic villus sampling: a systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2015;45(1):16–26).

If I have a positive or abnormal result from cell-free NIPT, can the Luna SCPD test be used to confirm my screening result?

Yes, if you have received an abnormal NIPT result, the Luna SCPD test is a good option to clarify the status of your pregnancy. The Luna SCPD test is a diagnostic test and can therefore distinguish between a true positive and a false positive NIPT result.

Can I do this test if my pregnancy isn’t considered high risk?

Yes, you can choose the Luna SCPD test whether your pregnancy is considered high risk or simply because you would like more information. The choice is yours.

Where can I get a copy of the consent form?

A copy of the consent form can be found under the "Providers" tab. Additionally, consent forms are provided in every test kit that is ordered.

Will my insurer cover this test?

For now, Luna SCPD is a self-pay test. Luna Genetics is working to secure insurance coverage. You can submit the test charge to your insurer, and it’s possible they will consent to cover all or a portion of the cost. If you would like to pursue this, Luna Genetics will provide a letter of support, just contact our genetic counselors.

What is the difference between a screening test and diagnostic test?

Prenatal screening tests only measure risk of certain genetic abnormalities, and there is a likelihood of false positives and false negatives. Whereas diagnostic tests, such as the Luna SCPD test, have demonstrated in clinical studies that they can detect the existence of specific genetic abnormalities.

What does the Luna SCPD test detect?

The Luna SCPD test detects gene deletions as small as 1.5 million base pairs of DNA and gene duplications as small as 2 million base pairs, enabling identification of extra or missing copies of entire or partial chromosomes. It also detects all aneuploidy and most deletions/duplications commonly linked to disease. The Luna SCPD test does not detect single gene disorders, e.g., cystic fibrosis, sickle cell anemia, Rett syndrome, and fragile-X syndrome (other testing methodologies should be used for single gene disorders).

What are the main advantages of the Luna SCPD test?

The Luna SCPD test is the first of its kind that is both diagnostic AND noninvasive. It is not a screening test – results are considered conclusive. The test provides precise diagnoses that, up until now, have required CVS or amniocentesis. And the Luna SCPD test can be performed much earlier than amniocentesis, and in most cases the cost is slightly less than the total for CVS and amniocentesis respectively when procedure costs and other items are factored in.

If I have the Luna SCPD test and the result is not diagnostic, would I still have time for amniocentesis?

There should be sufficient time to perform an amnio, depending on gestation. In general, the earlier the Luna SCPD test is performed the better.

What happens if I have the Luna SCPD test and no cells are found?

A blood sample redraw is offered at no extra cost and any charge is cancelled if no reportable cells are found.

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Testimonials

"This test is incredible and will supplant cell-free NIPTs in short order.

Hope the company has the bandwidth to test what is likely to become a flood of samples. The fact that it’s a diagnostic and can take the place of amnio/CVS is a really big deal. Even couples who are enthusiastic about genetic testing have some reservations about these tests due to their invasive nature. The Luna SCPD test changes this."

~Mark Zylka, Ph.D. researcher at UNC working on prenatal CRISPR treatment for Angelman syndrome
"If I’d had the option to take the Luna Prenatal Diagnostic Test to avoid the wait, I would not have hesitated.

After receiving an abnormal screening result from my noninvasive prenatal test (NIPT), I had to wait two months until I could undergo amniocentesis. It turned out the NIPT result was a false positive, but the months of waiting to get a normal diagnostic result on the health of my growing fetus were the two most difficult months of my life."

~Kim S., mother who experienced amniocentesis following an abnormal NIPT result.

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