Proven non-invasive technology

The verifi® prenatal test by Progenity ~1 in 4,000 Observed False Negative Results1
~1 in 500 Observed False Positive Results1
uses the proven Illumina® whole-genome massively parallel sequencing technology, which produces highly accurate prenatal screening results and the lowest test failure rate of any non-invasive prenatal test, as demonstrated in numerous publications including clinical experience on more than 34,000 patients1.

 

Verifi

Accurate results, the first time

The verifi® test by Progenity provides the lowest failure rate of any non-invasive prenatal test, from a single tube of maternal blood, and can be drawn at 10 weeks gestational age or later. Because the test was designed to be accurate at very low fetal fractions, patient samples are not rejected due to an arbitrary threshold.

  • Quick turnaround with results in 5–7 business days or less
  • No need for inconvenient redraws which cause delayed results
  • More time for confirmatory diagnostic results when needed


More options for more patients

The verifi® test by Progenity provides testing options for more of your patients, including singleton, twin, egg donor and surrogate pregnancies. It has been validated for use in both high-risk and low-risk patient populations, and provides additional testing options for microdeletions and trisomies 9 and 16.

Microdeletion syndromes

Microdeletions are chromosomal disorders caused by small missing pieces of chromosomal material, which can occur on any of the 23 pairs of chromosomes. Add the microdeletion option up to 60 days after the basic test—with no additional blood draw Most occur by chance, rather than being inherited from a parent, and can occur with no prior family history and without other risk factors, such as advanced parental age. They often cause serious health issues including both physical and intellectual impairment—the severity of which can vary from individual to individual. Early information can aid in pregnancy and newborn care. The verifi® by Progenity microdeletion panel covers five common and clinically relevant microdeletions:

Overall sensitivity of 91.6% and specificity of 99.84%

* No sensitivity estimates were performed for sample sizes <2. Titration of fragmented genomic DNA derived from cell lines containing either a 1p36 or 15q11.2 deletion demonstrated a linear dose response and confirmed the assay’s ability to measure copy number changes at those loci. 3

The microdeletion panel can be added up to 60 days after basic test results have been issued with no additional blood draw. This provides the ability to assess additional conditions should an abnormal ultrasound occur after the initial testing.

Trisomies 9 and 16

These trisomies often result in a first-trimester miscarriage, and usually occur spontaneously without any family history.

  • Trisomy 9—A rare chromosomal condition with the most affected pregnancies resulting in miscarriage in the 1st trimester. While live births usually will not survive the early postnatal period, those that do will have serious health concerns, including intellectual disability and cardiac defects.
  • Trisomy 16—The most commonly occurring autosomal trisomy seen in first trimester miscarriages. Rare survivors with mosaic trisomy 16 are at increased risk for health concerns including intra-uterine growth restriction, intellectual disability and cardiac defects.

There is a small increased risk for a woman to have a pregnancy with a viable trisomy following a miscarriage with trisomies 9 or 16. The ability to identify these important chromosomal causes of miscarriage can help with risk assessment as well as monitoring and management of subsequent pregnancies.

Easy to administer

  • Safe, non-invasive test—just one tube of maternal blood needed
  • Clear and simple result reports
  • Proactive notification of any positive result
  • Complimentary access to Progenity’s board-certified genetic counselors
verifi® by Progenity is a prenatal screening test. Clinical correlation with ultrasound findings and other screening tests is indicated. If definitive diagnosis is desired, chorionic villus sampling or amniocentesis is necessary. verifi® and Illumina® are trademarks of Ilumina, Inc. and/or its affiliates in the U.S. and other countries.

References

1. Bhatt et al. Clinical Laboratory Experience with Noninvasive Prenatal Testing: Update on Clinically Relevant Metrics. Poster presented at the 18th International Conference on Prenatal Diagnosis and Therapy; 2014 Jul 20-23; Brisbane. False negatives and false positives calculated for chromosomes 21, 18, and 13 only.
2. Bianchi et al. NIPT for Sex Chromosome Aneuploidy: Initial Clinical Laboratory Experience and Biologic Reasons for Discordant Results. Poster presented at the National Society of Genetic Counselors 32nd Annual Education Conference; 2013 Oct 9-12; Anaheim.
3. Noninvasive detection of fetal subchromosome abnormalities via deep sequencing of maternal plasma. American Journal of Human Genetics. 2013 Feb 7;92(2):167-76.