You can now recommend Whole
Genome Sequencing based
Claria NIPT from as early as
the 9th week of pregnancy
Claria Non Invasive Prenatal Test (NIPT)
You can now recommend SNP based
Claria NIPT from as early as
the 9th week of pregnancy
Claria Non Invasive Prenatal Test (NIPT)
Now available in India for the very first time, MedGenome Claria NIPT is an integrated solution of WGS based NIPT along with a highly customised and free genetic counselling service. Claria NIPT empowers you to guide and provide great clarity to your patients from as early as the 9th week of a pregnancy..
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 *
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
List of Conditions Tested by Claria NIPT
Trisomy 21
Down syndrome
Trisomy 18
Edward’s syndrome
Trisomy 13
Patau syndrome
Triploidy
Monosomy X
Turner syndrome
Sex
Chromosome
Trisomies
22q11.2
deletion
syndrome
1p36
deletion
syndrome
Prader Willi syndrome*
Angelman syndrome*
Cri-du-chat syndrome
Claria NIPT now also screens for Twins, Egg Donor and Surrogate Pregnancies
For the first time in India Claria NIPT determines
- Zygosity information
- Individual foetal fractions for dizygotic twins
- Monosomy X risk for monozygotic twins
- Rare Autosomal Aneuploidies
| Reported Conditions | Singleton | Twins, Egg Donor and Surrogate |
|---|---|---|
| Trisomy 21 | Yes | Yes |
| Trisomy 18 | Yes | Yes |
| Trisomy 13 | Yes | Yes |
| Monosomy X | Yes | No |
| Sex Chromosome Trisomies* | Yes | No |
Increased Number of Doctors in India Recommending Claria NIPT to Expecting Patients
Medgenome Claria NIPT Advantage
The unique molecular biology, bioinformatics and human approach, utilised by Claria NIPT provides greater quality control capability, making it one of a kind solution. Claria NIPT provides:
- Screens entire fetal genome* and not just trisomies in chromosomes 21, 18, and 13 which represent only a small portion of the genome
- Sensitivity and specificity of >99.9% for Trisomy 21, 18, 13
- >99% call rate
- 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.
- 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
- 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.
- Sensitivity – 96.4% (27/28)
- Specificity – 99.80% (2001/2005)
An absolutely FREE genetic counselling service.
Expert genetic counselling and a knowledge centre to help and guide your patients through the entire testing process
Superior over other NIPT’s
Claria NIPT can be performed from as early as the 9th week of gestation – earlier than any other test.
Offers consistently high levels of detection across all evaluated chromosomes.
Highest levels of sensitivity and lowest levels of false positives even at low foetal fractions
Claria NIPT does NOT perform gender determination.
All samples for Claria NIPT are collected only at certified PCP&NDT certified labs.
Reimbursement on diagnostic testing.
If the patients report comes in as a “HIGH RISK”, MedGenome will offer a complete reimbursement on the further confirmatory test
Medgenome Lab located in India – Unlike most other NIPT solution providers, MedGenome is the only entity to have a state-of-the-art lab in India. The samples do not need to be sent overseas for screening and therefore our response time is 2X faster. It only takes 10 to 15 days for the report and saves valuable time of your patient during the pregnancy.
Compliance
MedGenome is a PC & PNDT certified company. We adhere to the Pre-Natal Diagnostics Techniques (Regulation & Prevention of misuse) Act , 1994
MedGenome Claria NIPT does not disclose or test for the sex of the foetus.
Claria NIPT v/s Traditional Tests
With a sensitivity of over 99.84% and a false positive rate of less than 1%, every Claria NIPT report provides a personalized risk score which is far more accurate than traditional screening procedures.
Claria NIPT screens for more chromosomal abnormalities with greater accuracy. Compared to first trimester screenings Claria NIPT has higher sensitivity and low false positive rate for the conditions screened.
| Accuracy chart | First Trimester Screen (Sensitivity & False Positive Value) |
MedGenome NIPT (Sensitivity & False Positive Value) |
|---|---|---|
| Trisomy 21 Down’s Syndrome |
  |
  |
| Trisomy 18 Edwards Syndrome |
  |
  |
| Trisomy 13 Patau Syndrome |
  |
  |
| Monosomy X Turner Syndrome |
Does not screen
|
  |
| Triploidy |
Does not screen for
|
 |
| Optional Microdeletion Syndromes | ||
| 22q 11.2 deletion DiGeorge Syndrome |
Does not screen for
|
 |
| Monosomy X Turner Syndrome |
Does not screen for
|
 |
| MedGenome Claria NIPT and Claria NIPT plus | Maternal Serum Screening (MSS) | Chorionic Villus Sampling (CVS) | Amniocentesis | |
|---|---|---|---|---|
| SCREENING TESTS | DIAGNOSTIC TESTS | |||
| Timing | >9 weeks |
11-13 weeks and/or 15-22 weeks |
10-12 weeks |
15-22 weeks |
| False Positive Rate |
<1% | 5% | <<% | <<1% |
| No. of Chromo. Conditions Tested | >5+ Conditions T21 T18 T13 Monosomy X Triploidy, SCA |
2-3 Conditions T21 T18 & sometimes T13 |
All chromosomes |
All chromosomes |
| PPV | 91% for T21 | 5% | ||
Claria NIPT v/s
Other NIPT Offerings
| Feature | CLARIA NIPT and Claria NIPT plus | Others | Significance |
|---|---|---|---|
| Fetal Fraction |  |
 |
Huge advantage, reduces false negatives |
| Validation | Extensive | Variable | Huge advantage, reduces false negatives |
| Validation in India | |
|
Shows effectiveness in Indian scenario |
| PC & PNDT certified | Yes | Not known | Mandatory in India |
| Laboratory | Bengaluru | Shipped outside | Reduces transit time and need for redraws |
| Maternal contribution | |
|
Reduces false positives |
| Vanishing Twin | |
|
Reduces false positives, >15% False positives in others |
| Triploidy | |
|
Severe birth defects risks to mother, preeclampsia, cancer |
The Methodology
Claria NIPT based on Illumina VeriseqTM Solution v2 brings this whole-genome sequencing (WGS) approach to NIPT. Sequencing of the full fetal genome provides a comprehensive view of the chromosomes. This method offers an enhanced counting technique along with cutting edge algorithms to determine the risk of aneuploidies based on a ratio between chromosomes of interest to multiple reference chromosome.
Availability Centres
Samples for MedGenome NIPT are only collected at PCP-NDT certified centres.
Contact us Today
Call us at 1800 103 3691
Email us at diagnostics@medgenome.com
Validated Performance
of Panorama NIPT
| Validation T21, T18, T13, and MX3 |
Clinical Outcomes T21, T18, T13, and MX4 (Aneuploidy Incidence) |
||
|---|---|---|---|
| Sensitivity | Specificity | PPV* | |
| High Risk** |
98%(98/100)
98%98
|
99.5%(389/391)
99.5100
|
82.9%(2.4%)
82.9%83
|
| Average Risk** |
100%(5/5)
100%100
|
100%(389/391)
100100
|
87.2%(1.0%)
87.2%87
|
*PPV = Positive Predictive Value
– Dar et al, November 2014
**For the purposes of calculating PPV, high risk was defined as women of or above the age of 35 at the time of delivery, and average risk was defined as women below the age of 35.
Patient Conversation
It can be administered early into the pregnancy, at 9 weeks – earlier than any other prenatal test, which empowers the parents to make informed decisions about the future of their baby.
Medgenome Claria NIPT is backed by 21st century technology and PURE SCIENCE, and does not rely on any traditional methodology which are low on accuracy. It uniquely distinguishes between fetal and maternal cell-free DNA, leading to fewer false positives and a higher accuracy of over 99.84%.
Due to the higher false positive rates in traditional screening tests, many women might have to undergo the invasive tests of Amniocentesis /CVS unnecessarily and which carry a slight risk factor of miscarriage.
In the event of a positive result for any of the patients we will cover the costs for doing an AmnioCentesis test for that patient.
If you don’t
tell them,
who will?
Join us in empowering your patients with
the best options in genetic screening.
Become a Provider
Joining our provider network is very simple.
All you need to do is
email us at diagnostics@medgenome.com
or dial 1800 103 3691
Our representative will get in touch with you within 24 hours to help you with the registration. You can then start prescribing the test right away and help your patients gain clarity about their genetic health.