Claria From MedGenome

MedGenome is driven to enable clinicians to deliver the best outcomes to their patients. Our passion to deliver actionable insights to clinicians has resulted in the development of “Claria” - a suite of NGS (Next-Generation Sequencing) technology-based solutions for reproductive testing.

Claria offers the most accurate Non-Invasive Prenatal Screening Test (NIPT), the Genetic Carrier Screening Test and the Preimplantation Genetic Screening/Diagnosis (PGS/PGD).

Additionally, Claria offers an absolutely free, on-demand pre and post-test genetic counselling to all your patients.

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Chromosomal abnormalities in India
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1. Morris JK1, Wald NJ, Mutton DE, Alberman E. Comparison of models of maternal age-specific risk for Down syndrome live births. Prenat Diagn. 2003 Mar;23(3):252-8.
2. Snijders, et al. Ultrasound Obstet Gynecol 1999; 13: 167-170.
3. Combined prevalence using higher end of published ranges from Gross et al. Prenatal Diagnosis 2011; 39, 259-266;
Claria NIPT

MedGenome Claria NIPT is a simple, safe and non-invasive prenatal screening test that provides assurance to expectant parents with accurate genetic information about their baby.

  • Claria NIPT is the only test to be validated on the Indian population
  • This screening test can be performed from as early as the 9 -10 weeks of a pregnancy
  • Compared to first trimester screenings, Claria NIPT screens for more chromosomal abnormalities
  • Has a higher sensitivity and lower false positive rate for the conditions screened
Claria NIPT is now validated on Indian patients

NIPT has revolutionized prenatal screening for chromosomal aneuploidies around the world. Given the population variation as well as ethnic differences in India compared to the rest of the world, we evaluated the performance of this test in India. Below is a summary of our findings:

In this study, 96.6% potentially intermediate to high risk on conventional screening patient tested as low risk on NIPT thus avoiding invasive procedures for aneuploidy confirmation. The high negative predictive value provides significant reassurance to pregnant women.

4 Verma, I.C., Puri, R., Venkataswamy, E. et al. J Obstet Gynecol India (2018)
MedGenome offers the choice of two NIPTs.

Chromosomal Anomalies and Microdeletions that are detected

Claria NIPT

Aneuploidy (Singleton and Twins)

  • Trisomy 21 (Down Syndrome)
  • Trisomy 18 (Edwards’ Syndrome)
  • Trisomy 13 (Patau syndrome)
  • Monosomy X (Turner Syndrome) *
  • Other Sex Chromosomal abnormalities *
  • * Not available for twins


Claria NIPT plus

Aneuploidy

  • Trisomy 21 (Down Syndrome)
  • Trisomy 18 (Edwards’ Syndrome)
  • Trisomy 13 (Patau syndrome)
  • Triploidy
  • Monosomy X (Turner Syndrome)
  • Klinefelter Syndrome, Triple X Syndrome, Jacob’s Syndrome

Microdeletions

Microdeletions occur in 1-7% of all structurally normal pregnancies. They cause severe physical and/or intellectual impairments.

  • 22q11.2 Deletion Syndrome
  • 1p36 Deletion Syndrome
  • Prader-Willi Syndrome
  • Angelman Syndrome
  • Cri-du-chat Syndrome
Key Highlights of Claria NIPT
1. Comprehensive view of the fetal genome
  • Screens entire fetal genome* and not just trisomies in chromosomes 21, 18, and 13 which represent only a small portion of the genome
2. Test Performance
  • Sensitivity and specificity of >99.9% for Trisomy 21, 18, 13
  • >99% call rate
3. Low Test Failure Rates

NIPT test failure or no call rates vary significantly based on the test methodology used. Tests that use a targeted approach have demonstrated higher rates of test failure than WGS-based tests, in both validation and clinical experience studies.

WGS assays provide ample data across the entire diploid genome. This coverage produces an analytical reference that current analytical techniques can use to reduce assay- and sample-specific biases. These normalization steps lead to high sensitivity when working with low fetal fraction samples, which means correct aneuploidy calls can be made in the range of fetal fractions that typically requires QC rejection when using targeted approaches1.

4. Fastest Test Results
  • The Claria NIPT offers a fast three-step automated workflow for NIPT
  • The turn around time is less than or equal to 7 working days
5. Extensive Validation on Indian Samples

Claria NIPT is validated using 303 clinical samples from Indian population which included both known high risk samples and samples tested with cross platform. The validation successfully identified high risk cases and the low risk cases.

Who is Claria NIPT for?

All pregnant women who need insight into their baby’s development can avail the test, regardless of their age. Claria NIPT is recommended for all types of pregnancies.



Medical societies today support the use of NIPT as the first line of screening for all pregnancies, irrespective of the risk. For physicians, it is important to recommend this test for pregnancies where:

  • The woman is above 30 years of age
  • An abnormal ultrasound is reported
  • There is a family history of chromosomal conditions or birth defects
  • Couples have had a child with a chromosomal disorder
  • A couple has a history of infertility or pregnancy loss (miscarriages or stillbirths)
Why screening is important
  • Reassurance for expecting parents
  • Early information for better management
  • Preparation for the birth and early intervention wherever possible
Traditional screening test vs. Claria NIPT
Traditional screening test Claria NIPT
Test accuracy 75-90% >99.9%
False positives 5% <0.1%
Affected, undetected cases 10-15% <0.1%
Test applicability Can only be done from the 11th week onwards and within certain gestational time frames Can be done from as early as the 9th week of pregnancy and anytime after that during gestation
Why Claria NIPT?
Accuracy: Over 99.9%
Only NIPT to be validated in the Indian patient group
Reports fetal fraction in each case, providing greater confidence in the results of the test
FREE pre & post test genetic counselling for all patients
Only NIPT to process all samples at our CAP* accredited lab in India, enabling accurate and faster reporting
* College of American Pathologist- This is the highest standard of quality accreditation that is given to a diagnostic lab
Claria NIPT in 4 simple steps
To book the test, talk to our local representative or dial 1800 103 3691 or visit www.medgenome.com
Quick and simple blood draw from the mother’s arm, posing no risk to the baby
Receive highly accurate reports from our CAP accredited lab based in India
Review the test results. Our Genetic Counsellors and Scientific Advisors are always available to help you in interpreting and understanding the report
Assistance beyond screening tests. Free Genetic Counselling to all your patients

Free on-demand pre & post test genetic counselling to all patients. An information, education & service hub for patients & doctors.

How to avail of our Free Genetic Counselling services

Free on-demand pre & post test genetic counselling to all patients. An information, education & service hub for patients & doctors.

Doctor
MoU Sign a memorandum of understanding (MoU) with us to enroll for genetic counselling
Customized service Sign up for daily/fornightly/monthly service depending on the patient volume
Contact Contact a MedGenome sales representative for genetic counselling sessions for your patient
Phone 1800 103 3691
Email gcc.india@medgenome.com

Talk to our genetic experts for free today or reach us

Our certified genetic specialists are available right now to discuss your queries before, during and after screenings.

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