Non-Invasive Prenatal DNA Paternity

General Information

Parties wishing to establish paternity during the term of pregnancy have a new non-invasive option. 

Traditionally, prenatal testing required samples to have been obtained from CVS (Chorionic Villi Sampling) or Amniocentesis under a physicians direction. 

In many cases such sample collection was extremely difficult, and the risks to the fetus may not warrant such invasive procedures.  Through application of research technology it is now possible to determine the paternity of an unborn child using a simple maternal blood sample.

Non-Invasive prenatal testing utilizes a procedure that uses a mother's blood sample to separate the necessary fetal cells from the mothe'rs circulation.  These fetal cells are utilized in determining paternity relationships.  Samples are obtained from all parties to be tested including the expecting mother.  Once all samples have been received by the laboratory an extraction procedure will begin separating primordial fetal cells from the maternal blood samples.  Recent research has shown that fetal cells are extractable after 12 weeks fetal gestation.

			Invasive Prenatal		Non-Invasive Prenatal
	Sample		Amniocentesis: collecting the amniotic fluid that surrounds the fetus. Guided by ultrasound, an OB-GYN uses a long needle through the abdomen to collect fluid. CVS: collecting the chorionic villi that make up the placenta. Guided by ultrasound, an OB-GYN uses a catheter through the vagina or a long, hollow needle through the abdomen (depending on the position of the fetus) to collect cells.		Simple blood sample collection from the mother
	Time for Testing		Amniocentesis: between 14th and 22nd week of pregnancy. CVS: between 10th and 14th week of pregnancy.		After the 14th week of pregnancy
	Tested Parties		Mother and all alleged fathers		Mother and all alleged fathers
	Accuracy		99.9% for inclusions (the alleged father is the biological father of the fetus) and 100% for exclusions (the alleged father is not the biological father of the fetus).		99% for inclusions (the alleged father is the biological father of the fetus) and 100% for exclusions (the alleged father is not the biological father of the fetus).
	Results		in 5 to 12 business days (depending on the company)		in 12 business days
	Health Risks associated with procedure		Studies have indicated that the chances for fetal loss are increased by 0.5% for amniocentesis and 1% for chorionic villus sampling comparing to the normal pregnancy without the procedures.		NO HEALTH RISK FOR THE MOTHER OR THE FETUS
	Sample Collection Fee		Mother is required to pay a separate physician fee for prenatal sampling (CVS or amniotic fluid) that ranges between $500.00 and $1,500.00 depending from the collection facility. Most DNA testing providers do not advertise these prices on their websites.		Blood collection charges range between $15.00 and $50.00.
	Testing Fee		Ranging from $460.00 to $650.00 for testing mother and ONE alleged father. An average charge for an additional alleged father is $195.00.		$990.00 for testing mother and two alleged fathers.
	Shipping Fee		$25.00 to $50.00 depending on a courier company.		$50.00 for FedEx next business day delivery.
	Travel Costs		In most cases collection facilities are located in different cities or states. Additional travel expenses (on average $150.00)should be taken into consideration.		NO TRAVEL COST. Blood collection is arranged through a local medical laboratory.

Non-Invasive Prenatal Testing will determine the paternity of an unborn child with one alleged father for $990.  Each additional putative father is subject to $150.  Non-Invasive Prenatal Testing is more safe and cost effective than traditional prenatal testing.  Our laboratory will work together with each patient to collect all necessary samples throughout the world.

A variety of other diagnostic procedures based upon prenatal testing services are available.  Interested parties may additionally request sex determination and common inherited genetic disease mutation detection services.  Please call our offices for more information.

To determine if you are an eligible candidate for non-invasive DNA prenatal testing please call our customer care team toll free across Canada and the US at (877) 404-4363. If you are calling from outside North America please call (905) 607-8628.

Please contact your customer service representative for further information.

Fees

$990.00

Specimen Requirements

Buccal swab; 10cc Lavender

Turnaround Time

3-5 days, up to 5 days for complex analysis

Procedure

Initiating a Non-Invasive DNA Prenatal Paternity Test is a simple and easy process. Simply follow the instruction below for a convenient approach.

Call our toll-free number (877) 404-4363 to initiate your prenatal test or click here for downloadable version

Genetest will schedule you into a collection clinic in your local area for sample collection

Attend your collection appointment

Results are made available within 10-15 business days upon receipt of samples through the VERI Network and standard US Mail

Sample collection location sites are typically within your local area. Our database of affiliated collection sites will afford ease of collection in a proximate location.

Prenatal samples are collected Mondays through Thursdays only. All samples are received within 24 hours for viability of fetal cellular DNA.

If you are a client living outside North America or Europe our global affiliated collection sites will provide the same proximity of collection sites for obtaining of blood samples.

References

Non-Invasive Prenatal Diagnostics is a novel approach to establishing paternity since its inception in 2001. Utilizing novel cell isolation techniques, primordial fetal erythroblasts are separated and utilized for DNA diagnostic studies.

The science of the basis of such technology has been laden among the literature since 1990. Below are a collection of references highlighting the use of similiar isolation techniques for medical applications.

1.	Prieto et al. (2001) Optimization of nucleated red blood cell (NRBC) recovery from maternal blood collected using both layers of a double density gradient. Prenat Diagn. 21:187-193.
2.	Lo D (2000) Fetal DNA in maternal plasma: biology and diagnostic applications. Clin. Chem. 46:1903-1906.
3.	Perl et al. (2000) Detection of male and female fetal DNA in maternal plasma by multiplex fluorescent polymerase chain reaction amplification of short tandem repeats. Hum. Genet. 106:45-49.
4.	Chiesa et al. (1999) Detection of foetal cells in maternal blood and prenatal sex determination by in situ hybridization. Procedure verification. Genetic Analysis: Biomolecular Engineering 15:41-45.
5.	de Alba et al. (1999) Prenatal diagnosis on fetal cells obtained from maternal peripheral blood: report of 66 cases.
6.	Troeger et al. (1999) Approximately half of the erythroblasts in maternal blood are of fetal origin. Mol. Hum. Reprod. 5:1162-1165.
7.	Ganshirt et al. (1998) Enrichment of fetal nucleated red blood cells from the maternal circulation for prenatal diagnosis: experiences with triple density gradient and MACS based on more than 600 cases. Fetal Diagn. Ther. 13:276-286.
8.	Holzgreve et al. (1998) Prenatal diagnosis using fetal cells enriched from maternal blood. Croat Med J. 39:115-120.
9.	Lo et al. (1998) Quantitative analysis of fetal DNA in maternal plasma and serum: implications for noninvasive prenatal diagnosis. Am. J. Hum. Genet. 62:768-775.
10.	Watanabe et al. (1998) Prenatal diagnosis of ornithine transcarbamylase deficiency by using a single nucleated erythrocyte from maternal blood. Hum. Genet. 102:611-615
11.	Campagnoli et al. (1997) Noninvasive prenatal Diagnosis. Use of density gradient centrifugation, magnetically activated cell sorting and in situ hybridization. J. Repr. Med. 42:193-199.
12.	Cheung et al. (1996) Prenatal diagnosis of sickle cells anaemia and thalassaemia by analysis of fetal cells in maternal blood. Nature Genetics 14:264-268.
13.	Sekizawa et al. (1996) Prenatal Diagnosis of Duchenne muscular dystrophy using a single nucleated erythrocyte in maternal blood. Neurology 46:1350-1353.
14.	Busch et al. (1994) Enrichment of fetal cells from maternal blood by high gradient magnetic cell sorting (double MACS) for PCR-based genetic analysis. Prenat. Dign. 14:1129-1140.
15.	Ganshirt-Ahlert et al. (1993) Detection of fetal trisomies 21 and 18 from maternal blood using triple gradient and magnetic cell sorting. Am. J. Repr. Immun. 30:194-201.
16.	Bianchi et al. (1990) Isolation of fetal DNA from nucleated erythrocytes in maternal blood. Proc. Natl.Acad. Sci. 87:3279-3283

19 Feb 08		Complete Service Requisition Package (pdf)
07 June 08		Collection Instruction and Protocols (pdf)
21 Apr 07		Consent and Indemnity Agreement (pdf)
13 Jan 08		Chain of Custody Forms (pdf)

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