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Terms and Conditions

Please read these Genetic Testing Terms and Conditions carefully before submitting your order for genetic testing services from DNATraits, LLC.

By submitting your order, you provide your acceptance of these Terms and Conditions. If you do not agree to all of these Terms and Conditions, you may not use the site or gene testing services. DNATraits may revise these Terms and Conditions at any time and for any reason. Modifications may be posted on the website. By continuing use of the website and DNATraits services after such changes are made you will be accepting such changes.

These Terms and Conditions shall be governed by the laws of the State of Texas. The courts of Texas shall have exclusive jurisdiction over any claims or disputes arising in relation to, out of or in connection with these Terms and Conditions and genetic testing performed by DNATraits.

Information of the sample material

Genetic testing will be performed if:
1. the digital submission form has been filled in as required; and
2. quality, quantity and concentration of the sample material is in accordance with the requirements; and
3. the code of the sample material or patient’s name on the submission form is in full accordance with the code of the sample material or patient’s name marked on the sample container.
All requirements and instructions for samples are published on DNATraits website, and any questions to answers not posted in the website can be emailed to info@dnatraits.com.
DNATraits is not responsible for the loss of samples sent for testing or for samples sent to a wrong address or for breakage of a container during transportation.
DNATraits is entitled to ask for additional sample material if the quantity or quality needed for testing is not in compliance with the requirements.
DNATraits will inform the customer of the received sample by e-mail.
The sample material sent for testing is used only to perform the requested testing. No other laboratory studies are performed with the sample material. The remaining sample material is stored for 3 months after the test is completed, unless otherwise required by regulatory agencies. After 3 months the sample will be discarded. If a customer wishes DNATraits to store the sample for a longer period, he/she needs to inform DNATraits by email and pay the corresponding sample storage fee. If there is not enough sample material for storing or the customer wishes later to perform a repeated analysis on new sample material, DNATraits is not responsible for the differences in the results received by carrying out the new analysis. Sending back remaining sample material to the customer will be done at the customer’s expense.
Sample requirements
1. Specimen Type: Extracted DNA Shipping Conditions: Seal the tube with parafilm to prevent leakage. Ship at room temperature in an insulated container. Do not heat or freeze.
2. Specimen Type: Buccal Swabs from DNATraits kit Requirements: Two buccal swabs per individual, as submitted with the kit Shipping Conditions: Ship at room temperature in an insulated container. Do not heat or freeze.
3. Specimen Type: Dried Blood Requirements: Spot blood onto Whatman® FTA® Classic Card (Cat. No. WB12 0205). Include sample ID on each card. Shipping Conditions: Do not ship until completely dry. Place each card in an envelope and ship at room temperature. Do not heat or freeze.
4. Specimen Type: Blood Requirements: Draw blood in an EDTA (purple-top) tube(s) and send 3-5 cc. Shipping Conditions: Ship at room temperature in an insulated container by overnight courier. Do not heat or freeze.
5. DNA extracted from amniocentesis: Requirements: An additional DNA sample from the mother is required for testing of maternal contamination. A DNA sample from the father is strongly recommended. Shipping Conditions: Seal the tube with parafilm to prevent leakage. Ship at room temperature in an insulated container. Do not heat or freeze.

DNATraits will not charge for DNA extraction when in conjunction with an order for genotyping unless whole blood is received. The charge for DNA extraction from whole blood is 50USD.

Performance of the genetic test

The customer shall be a certified medical professional or a researcher. Proof of medical credentials is required before tests may be ordered. Researchers are not allowed to use the results of tests for diagnostic purposes. Prior to placing an order, the customer is responsible for getting the informed consent from the patient whose sample is sent for testing. After receiving the results of the genetic test, the customer is responsible for providing a genetic consultation to the patient. Genetic testing is for informational purposes only, it is not medical advice, and it is not a substitute for professional medical advice, genetic counseling, diagnosis or treatment.
Genetic testing performed by DNATraits is in accordance with the good laboratory practices and international quality requirements. The accuracy rate of testing is 99% or higher, the detection call rate (“present” vs. “absent”) at least 98%. The development of the genetic test and performance of the analyses is based on our current knowledge of the molecular biological data and it may change over time as more information becomes available. Due to the variability of DNA as a biological material and the molecular biological methods used, in rare cases the result of the genetic test may appear to be invalid, and/or be different from the quality conditions determined previously.

Testing Methodology

For Chromosomal Microarray Analysis (CMA)

total of no less than 400 ng should be supplied preferably at 50 ng/µl. Concentration will be verified prior to sample genotyping
Following the manufacturer’s protocol, samples are analyzed using the Illumina HumanOmniExpress BeadChip process and genome build GRCh37/hg19. All data collected is evaluated using Illumina’s GenomeStudio v2011.1 software. Genotypes obtained from the Illumina HumanOmniExpress BeadChip array are used to indentify copy number variations (CNVs).
CMA is performed using Nexus Copy Number 6.1 Standard Edition, as updated periodically. The Nexus analysis settings used for reporting CNV(s) are as follows:
1. SNP-FASST2 Segmentation
2. Significance Threshold = 1.0E-9
3. Max Contiguous Probe Spacing (Kbp) = 1000.0
4. Min number of probes per segment = 15
5. High Gain = 0.41
6. Gain = 0.13
7. Loss = -0.23
8. Big Loss = -1.1
9. 3:1 Sex chromosome gain = 1.2
10. 4:1 Sex chromosome gain = 1.7
11. Homozygous Frequency Threshold = 0.95
12. Homozygous Value Threshold = 0.8
13. Heterozygous Imbalance Threshold = 0.4
14. Minimum SNP Probe Density (Probes/MB) = 0.0
15. Regions Minimum Size (Kbp) = 50
The American College of Medical Genetics standards and guidelines for reporting of postnatal constitutional CNVs are followed to identify CNV(s) with pathogenic, uncertain clinical significance or benign significance:
1. Pathogenic CNVs: Observed CNVs are reported as pathogenic only when fully overlapping a CNV of clinical significance. In that case, well-established clinical syndromes are noted (Decipher as defined within Nexus) and to the extent feasible, gene(s) involved are specified (OMIM as defined within Nexus).
2. Uncertain clinical significance CNVs: Observed CNVs of uncertain clinical significance are further refined as likely pathogenic, likely benign or with no subclassification. In these cases, partially overlapping well established clinical syndromes are noted (Decipher as defined within Nexus) and to the extent feasible, gene(s) involved are specified (OMIM as defined within Nexus).
3. Benign CNVs: Observed CNVs are reported as benign only when fully overlapping a CNV of benign nature identified by the Nexus ‘more stringent DGV’ track.
Interpretative Comments
1. The observed CNV(s) are screened to identify genetic conditions of clinical significance.
2. Nexus CN 6.1 Standard Edition, as updated periodically, is used to complete the investigation.
3. The minimal CNV(s) region is used for interpretation of the observed CNV(s).
4. All CN events (Loss or Gain) contained within a suggested benign CNV(s) are screened to verify that the specific observed event was previously reported.
5. All genes contained within any CN Loss of uncertain clinical significance are systematically screened to identify a potential deleterious autosomal dominant effect.

For Homozygosity Mapping (Loss of heterozygosity)

A total of no less than 400 ng should be supplied preferably at 50 ng/µl. Concentration will be verified prior to sample genotyping
Following the manufacturer’s protocol, samples are analyzed using the Illumina OmniExpress BeadChip process. All data collected are analyzed using Illumina’s GenomeStudio software.
The results obtained from the BeadChip genotyping are summarized in an excel-based report indicating the SNP name, chromosomal position and actual genotype result for each of the array SNPs. In addition, the report will include the 20 largest homozygosity regions observed, the genes found within these regions and the OMIM phenotypes, whenever available.

For Gene Sequencing (Genes and mtDNA and targeted mutation analysis)

A total of no less than 800 ng should be supplied preferably at 10 ng/ul. Concentration will be verified prior to sample genotyping
Genomic DNA is extracted following standard protocols. DNA is amplified to obtain all coding exons and their flanking regions (approximately 50 bp on either side). All fragments are sequenced by forward and reverse internal primers when possible to determine the noted regions. When coverage with both forward and reverse primers is not possible, PCR and sequencing are performed in at least two independent reactions in one direction. Mutations are scored relative to the reference sequences deposited in the publicly available database NCBI and following the recommendations of the human genetic variation nomenclature scheme. Accordingly, exon 1 of the tested gene is defined as the exon in which the first ATG appears. Chromosomal positions are indicated according to the last reference assembly version - hg19. The term "mutation" is used to indicate "a disease-causing change". Similarly, the term "polymorphism" is used to indicate "a non disease-causing change".

For Exome Sequencing 80x - RESEARCH USE ONLY

Exome sequencing is achieved using the Nextera DNA sample preparation kit and the Illumina next generation sequencing HiSeq 2000 or 2500 platforms targeting an average coverage of 80x. This product is meant for research use only and, accordingly, is accompanied by no clinical report. The Nextera Exome Enrichment kit supports the discovery of the greatest number of variants, featuring a highly optimized probe set that delivers comprehensive coverage of exomic sequence, starting from only 50ng of DNA input. The kit includes more than 340,000 95mer probes, each constructed against the human NCBI37/hg19 reference genome. The probe set was designed to enrich more than 200,000 exons spanning 20,794 genes. The Nextera Exome Enrichment kit targets around 62Mb of the human genome.

Insert into the Notes field of the patient the DNA submission requirements:

Preferred extraction source: Blood. Please consult us before submitting DNA extracted from other non-blood non-contaminated human tissues. Buccal swabs are not accepted.
Detail your extraction method (Phenol Chloroform, Qiagen Kit, etc)
Elution Buffer (H2O, TE, EB, etc)
Quality (OD260/OD280) >1.8
Quantity (ng/ul) ) 20 ul of 50ng/ul

Turnaround time:

The current average turnaround time for processing is 10-14 weeks.

Deliverables:

The raw data as FastQ.
No analysis or interpretation will be provided.
Results will be delivered by means of secured FTP and notification by email.

Validation:

Upon completion of exome sequencing with DNATraits, you will be entitled to a validation package for an additional cost of $395.
The package includes validation of a maximum of five suspected variants.
Validation is based on bidirectional Sanger sequencing.
Suspected variants should be indicated by the referring physician.
Validation is good for up to four family members.
A detailed clinical report will be issued to summarize the validation results.

Special Pricing:

If you are interested in placing and order for a trio or quadruple special pricing is available.
Trio - $2550
Quadruple - $3400
To receive this special price please email info@dnatraits.com

Specimen Type and Shipping Conditions

Genetic testing will be performed if:

The digital submission form has been filled in as required; and
Quality, quantity and concentration of the sample material is in accordance with the requirements; and
The code of the sample material or patient’s name on the submission form is in full accordance with the code of the sample material or patient’s name marked on the sample container.

DNATraits is not responsible for the loss of samples sent for testing or for samples sent to a wrong address or for breakage of a container during transportation.
DNATraits is entitled to ask for additional sample material if the quantity or quality needed for testing is not in compliance with the requirements.
DNATraits will inform the customer of the received sample by e-mail.
The sample material sent for testing is used only to perform the requested testing. No other laboratory studies are performed with the sample material. The remaining sample material is stored for 3 months after the test is completed, unless otherwise required by regulatory agencies. After 3 months the sample will be discarded. If a customer wishes DNATraits to store the sample for a longer period, he/she needs to inform DNATraits by email and pay the corresponding sample storage fee. If there is not enough sample material for storing or the customer wishes later to perform a repeated analysis on new sample material, DNATraits is not responsible for the differences in the results received by carrying out the new analysis. Sending back remaining sample material to the customer will be done at the customer’s expense.

Specimen Type: Dried Blood Requirements: Spot blood onto Whatman® FTA® Classic Card (Cat. No. WB12 0205). Include sample ID on each card. Shipping Conditions: Do not ship until completely dry. Place each card in an envelope and ship at room temperature. Do not heat or freeze.
Specimen Type: Blood Requirements: Draw blood in an EDTA (purple-top) tube(s) and send 3-5 cc. Shipping Conditions: Ship at room temperature in an insulated container by overnight courier. Do not heat or freeze.

Any reporting requested by a customer, which differs from the above mentioned settings, will be applied to all customer’s orders. A fee will be required to modify the reporting settings a second time.

Interpretation of the results of genetic testing

The purpose of genetic testing is to evaluate the presence of the predisposition to genetic diseases, to assess the risk for developing a genetic disease, or to determine the carrier status of a known disease-causing mutation. The interpretation of the results of the genetic testing is based on our current knowledge of the molecular biological data and it may change over time as more information becomes available.
Negative result (no mutation detected) does not exclude the presence of predisposition for genetic diseases.
While assessing the disease risk, genetic information is one of the factors for developing the disease; environmental and life-style effects also play an important role. The total risk for developing the disease cannot be assessed based on the results of genetic testing. Increased risk for developing the disease does not necessarily mean getting the disease; whereas the disease may nevertheless present in low risk patients if environmental factors or other currently unknown risk factors decrease or increase the probability of getting the disease. Risk evaluation takes into account the risk in general population, which does not mean one-to-one risk for every single member of the population.
In the interpretation of the genetic test, it should be taken into consideration that current knowledge on the genetics of the disease or pathogenic disorder, or on the interactions of various genes, may be incomplete. The current interpretation of the genetic test may be subjected to change in the future due to the publication of new scientific investigations.
The result received based on the genetic test may not be complete, because many ethnic groups are not involved in scientific research. The results of genetic tests issued by DNATraits are based on published scientific research and may not be applicable to all ethnic groups.
DNATraits is not responsible for legal, material, social, psychological, or moral consequences that may appear in association to the results of gene testing.

Issue of the results

Unless otherwise noted in this Terms & Conditions, turnaround time for a genetic test is 4-8 weeks from the receipt of the samples. For genes that have already been validated, or for full mitochondria testing, DNATraits will do a best effort to deliver results in 4 weeks. Testing of genes that are not listed as available for testing or have not yet been validated can be ordered. In this case, the order will be charged only after successful validation. If within 4 weeks after the order was placed, DNATraits has not completed successful validation of the gene, the customer will be given the option to
1. cancel the request at no charge or
2. allow for continuation
of validation until DNTraits either successfully completes it, or informs the customer that it will not proceed due to unsuccessful attempts. For new gene orders that have been successfully validated within the initial 4 weeks or following an agreed upon extended period, the order will proceed and customer will be charged accordingly. For genotyping, in case of express service, upon payment of the express service fee, the test results are delivered within 14 working days from the receipt of the samples. DNATraits will do everything to submit the results of the genetic test at the first possibility, but DNATraits cannot take responsibility for the delay of the results due to unforeseen time-consuming incidents, in which case, the express service fee will be waived and the customer will pay the regular cost of the test. Turnaround time for CMA or Homozygosity mapping will be 3 weeks.
The express service fee is two times the listed price.
DNA tests submitted from amniocentesis during pregnancy are considered rush. Tests on such samples will be delivered 2 weeks after the sample is received at the lab, unless the test is for a gene that has not been validated, in which case the Terms & Conditions related to such situation will apply. Test from maternal contamination is mandatory at a fee of additional 250USD.
The test results will be issued only to the purchaser of the genetic test, which must be a licensed medical professional or researcher. Researchers are not allowed to use the results of tests for diagnostic purposes. DNATraits shall not disclose the personal data of the patient or the results of the genetic test to the third parties.
In some cases genetic results might be of “uncertain clinical significance”, and better understanding of those results will require that additional family members are also tested. In such cases DNATraits will discount the price of the same tests in additional family mambers to 70% of the published price.

Storage of DNA and Data/Reports

DNATraits will store the DNA for 3 months after the sample test is completed, unless otherwise required by regulatory agencies. After 3 months the sample will be discarded. If a customer wishes DNATraits to store the sample for a longer period, he/she needs to inform DNATraits by email and pay the corresponding sample storage fee.
The customer is responsible for keeping the raw data after reporting by DNATraits. DNATraits will store for a minimum of 3 months the customers’ raw data and reports, unless regulatory requirements prevent it from doing so, or a customer requests the data/report to be deleted.

Price and payment

DNATraits reserves the right to change prices at any time. Irrespective of any change of prices the customer will be charged the price, which was specified for the service when the order was placed.
Payment is required when the order is placed. For customers that place orders at a regular frequency and under certain conditions, DNATraits can create an account for monthly payment. This will require the customer contacting DNATraits and having a credit card on file for automatic debit at the end of the billing period. DNATraits is entitled to a fee of 5% of the unpaid amount, plus collection fees if a credit card is declined, and payment is not made within 5 days after the due date.
The price of tests performed for parents of an individual with results of “uncertain clinical significance” will be discounted to 70% of the published price.

Refund Policy

After a sample has been received at DNATraits lab and it has started the testing process, no requests for refunds will be accepted. If it is determined by the lab that the test cannot be performed due to the poor quality of the sample that was received, the customer will be entitled to resend a new sample for testing, but no refund will be issued.

Warranties and disclaimers

DNATraits, its divisions, subsidiaries, parent companies or their employees shall not be liable for any direct, consequential, indirect or any other damages arising out of performed gene tests or use of gene tests results. This includes liability for personal injury or death.
The customer hereby agrees to indemnify DNATraits, its divisions, subsidiaries, parent companies or their employees in respect to all loss or damage suffered in connection to use of this website or DNATraits gene testing services and in respect of all claims or legal proceeding brought by any third party which arise in connection to such services.
In no case shall the liability of DNATraits, its divisions, subsidiaries, parent companies or their employees exceed the amount paid by the customer for the particular genetic testing. Any claim against DNATraits, its divisions, subsidiaries, parent companies or their employees shall be submitted within 6 months as from issue of the test results, otherwise the claim is deemed to be expired.
Please note that DNA Traits does not accept orders for Individual Genome Sequencing services from Florida and New York.