Prenatal Screening

Trisome 21, 18, 13

Exceptional Performance

Luminus’ tests are validated for pregnant women of any age or risk categories and trusted by clinicians worldwide. AS EARLY AS 10 WEEKS, Luminus’ tests screen for the risk of trisome 21, 18, and 13.

 

Combined Performance Across All Clinical Studies 1-3, 7-13

  • Luminus’ tests have a less than 0.1% false-positive rate for trisomies 21, 18, and 13

  • This means fewer than 1 in 1000 Luminus’ tests yields a false-positive result. With conventional screening, as many as 1 in 20 women will receive a false-positive result 4

Greater clarity

Luminus’ tests have exceptional accuracy, bringing clarity to genetic testing for common trisomies.

  • In blinded clinical trials, tests correctly identified over 99% of cases of trisome 211-2

  • Conventional screening tests can miss 15% or more of trisome 21 cases4

 

Clear answers early, reduce follow-ups due to false-positives

Luminus’ tests help healthcare professionals give expectant parents accurate information about common fetal aneuploidies. 1-4 Conventional prenatal screening methods using serum proteins and ultrasound have higher false-positive rates compared to the Luminus’ tests.1-4 The low false-positive rate of Luminus compared to traditional tests may minimize anxiety and invasive procedures caused by false-positive results.5-6

Any age or risk category†

Luminus’ tests are clinically validated for use in pregnant women, of any age or risk category, to assess the risk of fetal trisomies 21, 18 and 13.1-3

  • Studied extensively in blinded prospective trials including more than 22,000 women of all ages1-2,8-9,11

  • Over 500,000 pregnancies tested worldwide13

A unique methodology

Luminus uses a targeted technological approach to DNA assessment—focusing on analyzing only the specific chromosomes of interest and the precise measurement of fetal DNA using SNPs (single nucleotide polymorphisms) to achieve greater accuracy.7

A DNA-based technology

When you are pregnant, your blood contains fragments of your baby’s DNA.
Luminus’ tests are a new type of tests that analyze DNA in a sample of your blood to predict the risk of Down syndrome (trisome 21) and certain other genetic conditions.

As early as 10 weeks

Luminus’ tests require a single blood draw. It can be done as early as 10 weeks or later in pregnancy.

Other commonly used tests for Down syndrome are performed later in pregnancy and may require multiple office visits.

A more accurate test

The Luminus’ tests are screening tests that are more accurate than traditional Down syndrome blood tests.1 The tests are much less likely to give a false-positive result compared to traditional tests such as the first trimester screening test. That means there will be much less chance your doctor would recommend follow-up diagnostic testing, such as amniocentesis.

Luminus also tests for two other genetic conditions, trisome 18 (Edward syndrome) and trisome 13 (Patau syndrome).

In addition, with Luminus you have the option to evaluate fetal sex, X and Y sex chromosomes.

Non-invasive prenatal testing based on cell-free DNA analysis is not considered diagnostic. Once you have your Luminus test results, you can discuss your pregnancy care with your healthcare provider.

  False Positive Rate* Detection Rate**
Harmony Prenatal Test Less than 1 in 1,600 More than 99 in 100
Traditional Test*** 1 in 20 79 in 100

 

 

 

 

 

†Both under 35 and over 35 age groups, studies have included women ages 18-48

* This test is designed to assess risk for trisome 21, 18, and 13 and sex chromosome aneuploidy. It cannot exclude all genetic defects nor detect every problem that may occur in pregnancy.

  1. Norton et al. N Engl J Med. 2015 Apr 23;372(17):1589-97.
  2. Norton et al. Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8.
  3. Ashoor et al. Ultrasound Obstet Gynecol. 2013 Jan;41(1):21-5.
  4. ACOG Committee on Practice Bulletin No. 77. Obstet Gynecol 2007;109:217-27.
  5. Wax et al. J Clin Ultrasound. 2015 Jan;43(1):1-6.
  6. Lou et al. Acta Obstet Gynecol Scand. 2015;94(1):15-27.
  7. Sparks et al. Am J Obstet Gynecol. 2012 Apr;206(4):319.e1-9.
  8. Verweij et al. Prenat Diagn. 2013 Oct;33(10):996-1001.
  9. Nicolaides et al. Am J Obstet Gynecol. 2012 Nov;207(5):374.e1-6.
  10. Ashoor et al. Am J Obstet Gynecol. 2012 Apr;206(4):322.e1-5.
  11. Gil et al. Fetal Diagn Ther. 2014;35:204-11.
  12. Juneau et al. Fetal Diagn Ther. 2014;36(4):282-6.
  13. Data on file.

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