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).

In addition to this Claria now offers not just advanced NGS based tests but also routine prenatal diagnostics and cytogenetic tests

claria-medgenome
Why is screening an embryo before implantation critical?
  • One-in-two human preimplantation embryos from IVF (in vitro fertilized) are chromosomally abnormal #
  • Even up to 40% of morphologically normal embryos harbour aneuploidies*
  • 70% pregnancy rate with PGS vs 40% without
  • Reduces number of IVF cycles the patient has to undergo
  • Improves the overall success rate of the IVF Center

# McCoy RC. Mosaicism in Preimplantation Human Embryos: When chromosomal abnormalities are the norm. Trends Genet. 33(7): 448–463 (2017).

* Harton GL, Munne S, Surrey M, et al. Diminished effect of maternal age on implantation after preimplantation genetic diagnosis with array comparative genomic hybridization. Fertil Steril. 2013;100(6):1695–1703.

Why PGS?
  • Leads to greater implantation rates and improved IVF outcomes
  • Reduces the number of IVF cycles required to achieve a successful pregnancy
  • Increases success rate for single embryo transfer
  • Reduces the likelihood of miscarriage due to Aneuploidies
  • Increases reproductive success rates in women above 35 years
When should a biopsy be done?
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A biopsy can be done on Day 3 (Blastomere) or Day 5 (Trophectoderm).

On Day 3, a fresh embryo transfer is possible. However, on Day 5,a frozen embryo transfer is possible, which is why Day 5 biopsy is recommended.

Why is Day 5 biopsy preferred for PGS?

  • At this stage, there are sufficient number of cells from which DNA can be isolated, thus ensuring success of the test
  • Mosaicism of Aneuploidies can be detected at this stage
  • Vitrification (rapid-freezing) of embryos after biopsy also allows the clinician to determine the optimum conditions for implantation
Calender 5

BLASTOMERE BIOPSY

  • Poorer representation of embryo’s cells (1 cell only)
  • Higher Test Failure Rate, as only one/two cell(s) is available for analysis
  • Cannot detect Mosaicism
Calender 5

BLASTOCYST BIOPSY

  • More cells (8-10 cells) = More DNA
  • Better representation of embryo’s cells (few cells)
  • Lower Test Failure Rate, as more number of cells are available for analysis
  • Can detect Mosaicism
Why Claria PGS is better?
With our wealth of technical expertise in Genomics, we have the most powerful solution for your needs.
Inherent flexibility to suit your needs without any compromise on quality.
We provide end-to-end support: From site validation and embryo biopsy training, to result data interpretation, phenotype correlation and genetic counselling
Robust sequencing technology that provides sensitive and replicable results.
Technology

Claria PGS is carried out using advanced Next-Generation Sequencing (NGS) technology

What are the advantages of NGS based techniques?
  • Rapid and convenient
  • Screening of all 23 pairs of chromosomes for abnormalities in one test
  • Able to detect greater than 20 Mb gains and losses in chromosomes
  • Higher resolution - 1Mb areas are analysed to provide data with high confidence
  • High sensitivity in detecting Aneuploidy (100 % sensitivity)
  • High specificity and accuracy (99.98% specificity)
  • Lower chances of test failure with NGS
Externally validated results

MedGenome’s PGS test has shown 100% accuracy in Aneuploidy detection, when external validation was done using Proficiency Testing (PT) samples by the American Association of Bioanalysts.

Advantages of PGS by NGS vs. other screening approaches
Fluorescent In Situ Hybridisation (FISH) Array Comparative Genomic Hybridisation (aCGH) Single Nucleotide Polymorphism (SNP) Microarray NGS
A largely manual process, highly skill/ operator dependant. Requires normal DNA for each sample to provide a comparison. A prolonged hybridisation step. SNP array analysis of DNA, extracted from a cell population, cannot indicate the mosaicism within the sample. NGS detects partial chromosomal gains and losses more precisely. NGS detects Aneuploidy and segmental imbalances at the same time.
Screening all 24 chromosomes at once requires a special probes set, requiring separate software at higher cost per sample. Levels of mosaicism of 20% or less will not be detected. Longer time needed to complete intended test. NGS provides more accurate detection of mosaicism of the Trophectoderm cells from blastocyst biopsy.
Difficult to resolve chromosomal overlaps/ split signals. Relatively expensive. Relatively expensive. NGS offers reduced costs and enhanced precision. It allows parallel analysis for multiple embryos for a single patient. In a single run, samples from different patients can be analysed together as well.
What can Claria PGS detect?
  • Turner Syndrome
  • Klinefelter Syndrome
  • Down Syndrome
  • Edwards Syndrome
  • Patau Syndrome
  • Other trisomies and monosomies which could increase the risk of implantation failure and miscarriage
  • Segmental Gain and Losses (>20Mb) in chromosomes which can lead to abnormalities in the embryo
Claria PGS workflow
pgsworkflow
What is Preimplantation Genetic Diagnosis (PGD)

PGD is a diagnostic procedure to test the material collected from an embryo for the presence of mutations carried by one or both parents. This is carried out when one or both genetic parents has a known genetic abnormality. In PGD every test is prepared on a case-by-case basis.

Possible candidates for PGD
  • Carriers of X-linked genetic disorders
  • Carriers of single gene disorders
  • Couples who have a child/ children affected by a single gene disorder
  • Couples who have a family history of a single gene disorder
What are the benefits of PGD?
PGD can test for most single gene disorders
PGD allows the clinician to select embryos that do not carry the single gene disorder being tested for the implantation
By using PGD, the single gene disorder can be prevented from being passed on from one generation to the next
How to order the Embryo Biopsy Kit

Contact Customer Support

MedGenome Labs Pvt. Ltd.,

Bangalore

Ph: 91-80-67154931

(At least 2 days in advance)

Clearly indicate number of kits required

Kits will be transported to the provided address at room temperature

Ensure the contents of the kit are intact before proceeding with the biopsy. Refer to the instructions on the kit

Dial 1800 103 3691
diagnostics@medgenome.com

Our representative will get in touch with you within 24 hours to help you with the registration. You can start prescribing the test right away and help your patients gain clarity about their genetic health.

Talk with one of our Genetic experts for free today

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

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