a new life. well planned.
non-invasive prenatal test Provide the best clarity and reassurance to your patients.
Claria
From MedGenome MedGenome is driven to enable clinicians to deliver the bes t outcomes to their pa tients. Our pa ssion to deliver actionable insights to clinicians has resulted in the development of “Claria� - a suite of NGS (Next-Generation Sequencing) technology-bas ed solutions for reproductive t esting. Claria offers the most accurate Non-Invasive Prenatal Screening Tes t (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 pa tients.
Non-Invasive Prenatal Screening test
Preimplantation Genetic Screening
Carrier Screening Test
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. This screening test can be performed from as early as the 9th week of a pregnancy. Compared WR ĆUVW WULPHVWHU VFUHHQLQJ &ODULD 1,37 VFUHHQV IRU PRUH FKURPRVRPDO DEQRUPDOLWLHV KDV D higher sensitivity and lower false positive rate for the conditions screened.
Claria NIPT now screens for microdeletions Claria NIPT now covers clinically relevant microdeletions that occur in 1-1.7% of all VWUXFWXUDOO\ QRUPDO SUHJQDQFLHV ,Q \RXQJHU ZRPHQ WKH ULVN IRU D FOLQLFDOO\ VLJQLĆFDQW deletion exceeds the risk for Down syndrome. These sub-chromosomal abnormalities which collectively have a population incidence of approximately 1 in 1000 will result in severe physical and /or intellectual impairments.
,Q \RXQJHU ZRPHQ WKH ULVN IRU D FOLQLFDOO\ VLJQLĆFDQW GHOHWLRQ H[FHHGV WKH risk for Down syndrome
Chromosomal abnormalities in India • High prevalence of chromosomal abnormalities: 1 in 200 births • Over 25 million births every year in India • Over 130,000 births with chromosomal abnormalities in India every year • Incidence of Down Syndrome is 1 in 850 live births in India • 1 in 1000 is the population incidence for microdeletions, the disorders included are 22q11.2 deletion syndrome, 1p36 deletion syndrome, Cri du chat syndrome, Prader-Willi syndrome, Angel man syndrome*
A woman’s risk of having a term pregnancy with certain chromosomal abnormalities increases with age.
* Combined prevalence using higher end of published ranges from Gross et al. Prenatal Diagnosis 2011; 39, 259-266; and www.genetests.org. Total prevalence may range from 1/1071 - 1/2206.
The risk of having a baby with Down Syndrome* For a 26 yr old woman: 1 in 1300 For a 36 yr old woman: 1 in 270
The risk factor increases by almost 5x
However, the incidence of microdeletions is independent of maternal age.
Incidence of microdeletions at birth 1/250
1/500
1/1000
1/2000 20
22
24
26
28
30
32
34
Maternal Age Down Syndrome1
Panorama Microdeletions Panel 2
0RUULV -. :DOG 1- 0XWWRQ '( $OEHUPDQ ( &RPSDULVRQ RI PRGHOV RI PDWHUQDO DJH VSHFLĆF ULVN IRU 'RZQ syndrome live births. Prenat Diagn. 2003 Mar;23(3):252-8. 1 Snijders, et al. Ultrasound Obstet Gynecol 1999; 13: 167-170. 2 Combined prevalence using higher end of published ranges from Gross et al. Prenatal Diagnosis 2011; 39, 259-266; and www.genetests.org. Total prevalence may range from 1/1071 - 1/2206.
What are the chromosomal and structural anomalies detected by Claria NIPT? Common aneuploidies T21, T18, T13, Sex Chromosomes abnormalities, triploidy and 5 common microdeletion syndromes from fetal DNA obtained from maternal blood.
Aneuploidy
Microdeletions
• Trisomy 21 (Down Syndrome)
• 22q11.2 Deletion Syndrome
• Trisomy 18 (Edwards’ Syndrome)
• 1p36 Deletion Syndrome
• Trisomy 13 (Patau syndrome)
• Prader-Willi Syndrome
• Triploidy
• Angelman Syndrome
• Monosomy X (Turner Syndrome)
• Cri-du-chat Syndrome
• Klinefelter Syndrome, Triple X Syndrome, Jacob’s Syndrome
Unlike other tests, Claria NIPT also tests for triploidy and vanishing twin. It is the only test that differentiates between maternal and fetal DNA, which helps avoid false positives. Claria NIPT does not test for the gender of the foetus. 0HG*HQRPH LV D 3& 31'7 FHUWLĆHG FRPSDQ\
Why screening is important • Reassurance for expecting parents • Early information for better management • Preparation for the birth and early intervention wherever possible
Why Claria NIPT? Over 99.9% accuracy Can be screened from as early as the 9th week of a pregnancy. A simple, and safe blood draw from mothers arm, posing no risk to the foetus The only SNP technology based NIPT in India
Reports foetal fraction in each case
FREE Pre & Post test genetic counseling for all patients The only lab to process NIPT samples in India, enabling for accurate and faster reporting.
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 pregnancies. 0HGLFDO VRFLHWLHV WRGD\ VXSSRUW WKH XVH RI 1,37 DV WKH ĆUVW OLQH RI VFUHHQLQJ IRU DOO SUHJnancies, 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 report • Couples with a family history of chromosomal conditions or birth defects • Couples who have had a child with a chromosomal disorder • Couples with a history of infertility or pregnancy loss (miscarriages or stillbirths)
Traditional screening test vs. Claria NIPT
Traditional screening test
Claria NIPT
Test accuracy: 75-90%
Test accuracy: >99.9%
False positives: 5%
False positives: <0.1%
Affected, undetected cases: 10-15%
Affected, undetected cases: <0.1%
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
Claria NIPT in 5 simple steps 1. Ask about Claria NIPT To book the test, dial 1800 -1037590 or visit www.medgenomeclaria.com and we will help you locate the sample collection centre closest to your patient.
2. Quick and simple blood draw A small sample of blood is drawn from the motherâ&#x20AC;&#x2122;s arm. This is a non-invasive procedure and poses no risk to the baby.
3. Receive highly accurate reports Medgenome is the only lab enabled to process NIPT samples in India. This ability allows for high accuracy and faster reporting.3. Receive highly accurate reports
4. Review the test results Our Genetic Counsellor and Scientists will help you understand the detailed report and guide you accordingly.
5. Get in touch with us for counselling <RXU SDWLHQWV FDQ FDOO RXU WROO IUHH QXPEHU DQG Ä&#x2020;[ DQ DSSRLQWPHQW WR JHW D IUHH FRXQVHOOLQJ session with one of our genetic counselling experts.
The Claria NIPT advantage for your patients The CLARIA NIPT ADVANTAGE for your patients: • Over 99.9% accuracy • Can be screened from as early as 9th week of a pregnancy • A simple, and safe blood draw from mothers arm, posing no risk to the foetus • The only SNP technology based NIPT in India • Reports foetal fraction in each case • FREE Pre & Post test genetic counseling for all patients • The only lab to process NIPT samples in India, enabling for accurate and faster reportingv
Order now MedGenome Labs Pvt. Ltd. 3rd Floor, Narayana Netralaya Building, Narayana Health City, #258/A, Bommasandra, Hosur Road, Bangalore – 560099 Toll free no: 1800-1037590 | SMS ‘CLARIA’ to 56767 www.medgenomeclaria.com | doctorsupport@medgenomeclaria.com