Testing Frequently Asked Questions

Specimen Requirements

What kind of specimens do you accept?

PreventionGenetics accepts whole blood, purified DNA, cell cultures and a number of other specimen types. Details are listed on our Specimen Requirements page.

Is a separate tube of blood required for each test?

No, only one tube of the required 3 ml - 5 ml of blood will be sufficient to perform multiple tests. Blood should be collected in an EDTA (purple top) or ACD (yellow top) tube.

I am drawing a specimen from an infant. What is the minimum amount of blood required?

We require a minimum of 1 ml of whole blood in an EDTA (purple top) or ACD (yellow top) tube.

What is the stability of a blood specimen?

If the blood is stored at room temperature, it is good for up to 48 hours. If the blood is refrigerated, it is good for up to one week. Do not freeze the blood.

Does PreventionGenetics accept DNA extracted in other laboratories?

Yes, PreventionGenetics accepts purified DNA. We request that DNA be sent in a screw cap tube with at least 5µg – 10µg of purified DNA at a concentration of at least 20 ng/µl for NGS and Sanger tests and at least 5µg of purified DNA at a concentration of at least 100 ng/µl for gene centric aCGH, MLPA, and CMA tests, minimum 2 µg for limited specimens. For requests requiring more than one test, send an additional 5 µg DNA per test ordered when possible. We require that concentration, composition of the solute and identity of the specimen be clearly indicated on the DNA tube and/or Test Requisition Form. PreventionGenetics does not accept products of whole genome amplification or other amplification products.

What are the requirements for a prenatal specimen?

We accept fetal DNA, fetal tissue, cultured fetal cells, or direct CVS/amniotic fluid. However, acceptable specimen type is dependent on the fetal testing requested. Culture and send at least two, T25 flasks of confluent cells. For sequencing or gene-centric aCGH panels, two flasks are often sufficient; however, some panels may require additional flasks (dependent on size of genes, amount of Sanger sequencing required, etc.). Multiple test requests may also require additional flasks. Please contact us for details. Most tests can also be performed using 5 µg of purified DNA. We strongly recommend maintaining a back-up culture. PreventionGenetics offers cell culture via Test Code 995 for $250. Cell cultures and direct fetal specimens are routinely accepted Monday - Thursday and require advance notice of arrival. See our Prenatal Testing Guidelines for more information. A signed Health Care Provider's Statement is required for all prenatal tests with ongoing pregnancies, which can be found within our Prenatal Test Requisition Form & Provider Statement on our Forms page. At this time, PreventionGenetics is not validated to offer prenatal testing for MLPA or repeat expansion testing. We also currently do not offer whole exome sequencing (WES) for ongoing pregnancies.

What paperwork do I need to include with each specimen?

A completed Test Requisition Form, found on our Forms page, must accompany each specimen. Incomplete paperwork will delay testing.

Shipping

How do I send a specimen?

Blood specimens should be shipped in a crushproof, insulated container. Whole blood and cell cultures are usually sent by overnight courier. Purified DNA may be sent by a slower mechanism. All specimens should be accompanied by a completed Test Requisition Form, found on our Forms page.

Where do I ship a specimen?

PreventionGenetics
Attention: Diagnostic Lab
3800 S. Business Park Ave
Marshfield, WI 54449

For international clients- Attention: Ann Solatycki

Do you accept Saturday or holiday deliveries?

We accept whole blood and DNA Monday-Saturday. Cell cultures and prenatal specimens are only accepted Monday-Thursday, and we prefer to be notified in advance of their arrival. PreventionGenetics is closed on major holidays.

Can I ship specimens by regular postal mail?

We do not recommend shipping blood specimens or cell cultures by mail. They should be shipped by overnight express. Purified DNA may be shipped through postal mail.

Does PreventionGenetics pay for shipping?

Yes. We are pleased to offer clinical testing kits with paid return shipping for our US clients. We can send kits internationally, but are unable to pay for return shipping for our international clients at this time. If you would like to order clinical testing kits, please use our electronic order form.

Turnaround Times

How long do results take?

Please see our Turnaround Times page for details.

Do you have a STAT option for ordering a test?

Yes, we offer a STAT option for Sanger sequencing and gene-centric aCGH. The great majority of STAT tests are completed within 8-10 calendar days. If we are unable to complete STAT requests within 10 days, STAT surcharges (25%) will be waived. We now offer a Rapid CMA test (Test Code #3780). For urgent gene-centric aCGH, or NextGen Sequencing Panel requests, please contact us.

How long do prenatal tests take?

The great majority of targeted prenatal tests are completed within 8-10 days. For full gene sequencing via NGS and Sanger and deletion/duplication testing via aCGH, please refer to the test descriptions. We prioritize all testing related to ongoing pregnancies in order to get the results out as quickly as possible. Please alert us if you order testing for situations of extreme clinical urgency.

What is your procedure to add-on another test for a patient who was tested previously at PreventionGenetics?

Additional tests can be ordered by faxing the Add-On Test Requisition Form to 715-384-3661. We will contact you if we require a new specimen to complete the requested testing.

Do I have to send another specimen if I am adding on a test?

Usually not. PreventionGenetics retains unused DNA from previous tests. If a blood specimen was originally sent, we nearly always have sufficient DNA to perform additional tests. If a limited amount of purified DNA was originally sent, or if the specimen originated in NY state, then a second specimen will often be required.

Billing

What is your tax identification number?

PreventionGenetics LLC Tax Identification Number is 83 0343803.

Does Preventiongenetics accept insurance?

PreventionGenetics will file an insurance claim on behalf of a patient with any commercial insurance company.

What is necessary for PreventionGenetics to bill insurance?

Page 3 of the TRF indicates the information needed for insurance billing. This section must be completed in its entirety before testing can begin. This includes additional information such as pre-authorization information, pertinent medical record information, and/or a letter of medical necessity.

If insurance has been verified and preauthorization obtained, why would my patient receive an invoice for charges (partial or total)?

Preauthorization does not guarantee payment. Insurance companies determine payment and what charges will be billed to the patient after a medical claim is filed.

As a friendly reminder that the test has been completed and there is the possibility of some financial obligation from the patient, an invoice will be mailed to the patient after testing is complete. The invoice will indicate that an insurance claim has been filed and no payment is due at this time. A monthly statement indicating an insurance claim is in process will also be mailed to the patient. No payment will be required from the patient until the insurance claim has been processed and closed. Once insurance payment has been received, the monthly statement will indicate the remaining balance and note that the remaining amount is now due from the patient.

The patient is responsible for notifying PreventionGenetics of the status of the explanation of benefits (EOB) and remitting any funds received directly from the insurance company to PreventionGenetics.

The patient is responsible for any portion of the test fee not covered by the insurance company for any reason including, but not limited to, co-payments, co-insurance, unmet deductibles, or non-covered services.

How can patients find out how much their insurance will cover?

While preauthorization does not guarantee payment, PreventionGenetics can assist with pre-verification or pre-authorization of insurance coverage. For assistance please complete the insurance pre-verification/pre-authorization form found on our website or call our insurance specialists at 715-387-0484 extension 266 or 185.

Where are the specific CPT codes and prices for the test I'm ordering?

A spreadsheet containing CPT codes and prices for our tests can be found here. Each test description also lists the CPT codes for testing.

Does PreventionGenetics participate in any Medicare or Medicaid plans?

We are a contracted provider for Medicare and Wisconsin Medicaid. At this time we do not accept any other state's Medicaid.

The patient must meet Medicare criteria for genetic testing in order for the services provided to be considered covered and reimbursable by Medicare. We do require Medicare patients to sign a completed advance beneficiary notice (ABN) in advance of testing to acknowledge financial responsibility should the testing not meet Medicare criteria for covered service.

Is PreventionGenetics contracted with private insurance companies?

We are a contracted provider for Security Health Plan and HealthChoice (State of Oklahoma). We are also a contracted provider for Wisconsin Medicaid.

Does PreventionGenetics bill institutions?

Yes, PreventionGenetics will invoice the institution or provider directly for the total test fee once the report has been sent to the ordering healthcare provider.

Does PreventionGenetics offer patient self-pay?

Yes, we will bill the patient directly. The individual accepting financial responsibility for the test fees must sign the acknowledgement statement on the Test Requisition Form. The responsible billing party must be at least 18 years old.

Does PreventionGenetics require pre payment for self-pay testing?

No. We do not bill for the test until testing is complete. We do not require a credit card to be on file, however, having a credit card authorization on file allows for easy payment processing once the test has been completed. PreventionGenetics accepts Visa, MasterCard, and Discover. We can also accept payments by bank wire transfer, Automatic Clearing House (ACH), or check.

Does PreventionGenetics offer different pricelists for different payment types?

Regardless of the nature of payment or payer, we strive to provide the lowest prices in the market and therefore, our prices do not vary for different payment options. Our prices are transparent and openly published on our website. We offer three (3) convenient payment options for testing services: we can bill the ordering institution/provider directly (institutional billing), we can bill the patient directly (self-pay), or we can bill the patient's commercial insurance company (insurance billing).

What Date of Service does PreventionGenetics use?

Date of service (DOS) on the invoice will be the accession date. If the DOS must reflect the date that testing is started (rather than accession date) please contact our billing team to make arrangements.

What are the payment terms?

Payment is due 30 days from the date of the invoice, or 30 days from the date the insurance claim closes. Please contact our billing team to discuss payment plans if necessary.

What happens if we cancel a test?

If you need to cancel a test, please contact our client services department.

Test Information

Does PreventionGenetics provide detailed information for each test?

Yes, a detailed Test Description for each test is freely and easily available from our web site. Just search a test to begin.

Can we order testing for a specific mutation, or do we have to order the entire gene?

We offer single (Test #100, $250), double (Test #200, $370) or triple (Test #300, $440) exon sequencing for any of the genes on our test menu. These tests are typically performed for relatives of the probands or for confirmation of test results from other labs. Please specify the mutation fully in the comments section at the bottom of page 1 of the Targeted Variant Test Requisition Form.

Do you offer Deletion/Duplication testing?

Yes, PreventionGenetics offers a custom designed, high probe density, gene-centric aCGH test (our Test #600) which targets many of the genes on our test menu. Please specify the desired genes in the comments section at the bottom of page 1 of the Test Requisition Form.

Do you offer free family testing for Variants of Unknown Significance?

We offer free testing for variants of unknown significance in up to two family members of probands who had full gene sequencing completed at PreventionGenetics. Free testing for deletion/duplications of unknown significance discovered by aCGH or CMA will be available for up to two family members of the proband only if we are able to test the del/dup by PCR. Please complete our Targeted Variant Test Requisition Form and mark the "No Charge" box on the Test Selection box on page 1.

Do you require positive control specimens for targeted mutations?

If the family member was tested at an outside laboratory, we recommend that you submit a specimen from that individual to serve as a positive control. The positive control specimen will be tested free of charge and no report will be provided. If a positive control is not provided, negative results will carry a limitation stating that PreventionGenetics did not have the opportunity to verify that we can detect the variant in this family. Positive controls are required for targeted prenatal testing.

If I only want to order a single gene, but it's only available on a NextGen Sequencing panel, can I order it individually?

Yes in these situations please contact us to discuss pricing. Please indicate "Interpret only XXXX gene" on the Test Requisition Form. In the event that more than 1 gene is desired (but not the full panel), please contact us for customized pricing details.

Can I order a NextGen Sequencing panel update?

If our NextGen Sequencing panel is updated to offer additional genes, we will offer a panel update for a charge of $990. Please contact us to confirm that we have adequate DNA remaining, and then complete our Add-On Test Requisition Form, found on our Forms page, specifying NextGen Sequencing panel of interest and "Update". The interpretation will include only the genes that have not been previously analyzed. CPT codes for newly added genes apply.

If I order a smaller NextGen Sequencing panel that is negative, can I reflex to a larger NextGen Sequencing panel?

Yes, for many of our NextGen Sequencing panels we offer smaller, more focused disease-specific panels and also a broader, more comprehensive panel. In particular, for any exome based test, we can reflex to whole exome sequencing (PGxome) for $990.

Certificates & Licenses

Is PreventionGenetics CLIA accredited?

Yes, identification number 52D2065132. The certificate is posted on our website.

Is PreventionGenetics CAP accredited?

Yes, CAP number 7185561, AU-ID 1407125. The certificate is posted on our website.

Is PreventionGenetics ISO 15189 accredited?

Yes, we are ISO 15189 accredited. Our certification number is 3950.01 and is posted on our website.

Do you hold any state licenses?

Yes, PreventionGenetics is currently licensed by the states of New York, California, Maryland, Florida, Pennsylvania, and Rhode Island. The certificates are posted on our web site. For New York approved tests and more details please see our NY Landing Page.