Certifications and Important Numbers
Is Blueprint Genetics an accredited diagnostic laboratory?
Yes. Blueprint Genetics is accredited by both ISO 15189 and College of American Pathologists (CAP). The ISO 15189 standard accreditation is carried by FINAS,
Finnish Accreditation Service, laboratory no. T292, accreditation requirement SFS-EN ISO 15189:2013 and the information about the scope is available on the website: FINAS.
Is Blueprint Genetic CLIA certified?
We are a CLIA certified laboratory for high complexity testing (#99D2092375) approved by US authorities (Centers of Medicare & Medicaid Services – Clinical Laboratory Improvement Amendment Survey and Certificate Group) qualifying us to operate in 46 states or districts in USA (Alabama, Alaska, American Samoa, Arizona, Arkansas, Colorado, Connecticut, Delaware, District of Columbia, Guam, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Northern Mariana Islands, Ohio, Oklahoma, Oregon, Puerto Rico, South Carolina, South Dakota, Texas, Utah, Vermont, Virgin Islands (US), Virginia, Washington, West Virginia, Wisconsin, Wyoming). In addition, we have CA State License (#COS800637), valid until Oct 22, 2016.
Does Blueprint Genetics comply with the EU Safe Harbor Framework?
Blueprint Genetics complies with the U.S.-EU Safe Harbor Framework as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal information from European Union member countries. To learn more about this program, please visit http://www.export.gov/safeharbor/
Are your tests FDA-approved?
Our tests are developed and validated in-house and the FDA has determined that such clearance or approval is not necessary.
Clinical Genetics Support
Clinical Genetics Support
Blueprint Genetics offers Clinical Genetics Support for situations requiring specialized expertise in genetic diagnostics.
These situations include:
- questions on challenging biological samples and shipment strategies
- discussions on selecting an optimal diagnostic tool for your patient
- questions concerning the clinical statement and discussions on variant classification
- assistance in genetic counseling of your patient and the family
- other requests that require tailoring of our service to your clinical needs.
Our mission is to improve our services and our Clinical Genetics Support team is happy to discuss strategies that can lead to better service and improved quality of diagnostics.
When contacting us, you will have a chance to discuss your issue with our Clinical Team consisting of physicians, geneticists or genetic counselors. You may send your requests via email email@example.com and we will respond to you within 24 hours or contact you by phone if requested. You may also call our Customer Support in North America at (650) 452-9340 or in Europe at +358 40 2511 372 which will direct your call to our Clinical Team.
Our Customer Support can also assist you with all other practical issues such as billing, sample collection kits, ordering options or to evaluate the status of your patient’s analysis.
What is the procedure for adding on further testing to a sample already at Blueprint Genetics?
An additional test can be added on to a sample already at Blueprint Genetics by making a new order in our system and notifying this exception in the referral. In this case, write the ID number of the previous purchase on the new referral.
I would like to order another test on a patient who was tested previously. Do I need to submit another sample?
No. Generally, we obtain enough DNA from one sample to allow completion of another test. A second sample is not usually necessary and in case of any exceptions the referring physician will be promptly informed.
What payment methods can I use?
You can use either bank transfer, Credit Card or PayPal. In US and Canada, checks are also accepted.
What is the US billing policy of Blueprint Genetics?
At Blueprint Genetics, we believe that cost should not be a barrier for patients or families who require genetic testing. Our mission is to improve access to genetic testing when clinically required. Blueprint Genetics will work with all commercial insurers and every patient with active insurance benefits will qualify for Blueprint Genetics diagnostic testing services. The amount the patient will pay for genetic testing is dependent on their insurance coverage and ability to pay. When we receive a sample at Blueprint Genetics we work with the patient and their physicians to obtain the maximum reimbursement from the insurance provider. Our billing specialist will manage the claim process and offer financial assistance and/or a flexible payment plan to eligible patients. This policy does not currently apply to US patients with Medicare and Medicaid, or patients outside the USA.
Patients with commercial insurance
Blueprint Genetics will perform an insurance benefit investigation once a patient sample and test requisition are received. If the patient’s financial responsibility is greater than $100, our billing specialist will contact the patient or family directly and inform them of any unmet deductible, co-pay, and co-insurance, as well as explain their payment options under our Financial Assistance Program (FAP). Blueprint Genetics billing specialists will process insurance prior authorizations (PA) on behalf of the patient whenever allowed, and will assist clinicians with submitting letters of medical necessity (LOMN) and supporting clinical documents. Blueprint Genetics complies with all appropriate statutes and rules governing insurance billing and claims for reimbursement.
The patient is responsible for any co- insurance, co-pay, and unmet deductible established by the patient’s insurance carrier. Blueprint Genetics has a generous Financial Assistance Program and payment plan options for patients and families who experience economic challenges associated with their clinical situation or family income level. This may significantly reduce the patient’s financial responsibility. Contact our customer support for more information at (650) 452-9340 or firstname.lastname@example.org.
If the patient is not completely satisfied with our billing solution under the Blueprint Genetics Financial Assistance Program there is no obligation to move forward with testing. If the patient decides to cancel the test, we will contact the ordering physician to get their approval before cancellation.
Blueprint Genetics offers a self-pay option for patients who participate in government insurance programs, are underinsured, or indigent. In addition, Blueprint Genetics offers a self-pay option for patients with commercial insurance policies that are structured with extraordinarily high deductibles or restrict access to the specialty genetic testing services provided by Blueprint Genetics. Simply select the self-pay option in the requisition form and enter the patient’s email address or phone number. We will follow-up with the patient to gather the necessary payment information. Blueprint Genetics accepts most commonly used credit cards and checks. Contact our customer support for information on self-pay options at (650) 452-9340 or email@example.com.
Clinics, hospitals, laboratories, and physicians may establish an institutional billing account with convenient monthly invoicing and payment options. Complete billing information must be on the test requisition form when samples are submitted. For questions about establishing an institutional billing account, please contact our customer support at (650) 452-9340 or firstname.lastname@example.org.
What is the global billing policy of Blueprint Genetics?
Blueprint Genetics provides clinical genetic diagnostics throughout the globe with significant variability in healthcare systems and billing policies. In principle, Blueprint Genetics invoices the payer or customer when the analysis is complete. Exceptions with this policy may occur. Blueprint Genetics offers diagnostic services only when ordered by a healthcare professional. Blueprint Genetics may have different pricing and service models in different territories. Our philosophy is full transparency in pricing.
Can I set up an institutional billing account?
Yes. Generally an account is set to each department of the hospital. Simply provide the contact information (name, phone and fax numbers, email/physical address) to which we can mail an invoice.
Who can order genetic tests from Blueprint Genetics?
Our genetic tests can be ordered only by qualified healthcare professionals.
What should I consider before ordering a test?
Before ordering a test, a healthcare professional should explain to the patient to be tested:
- What is the purpose of the test
- What the test results mean (including positive, negative and possible uncertain results)
- That the results might reveal information about patient’s family members’ health.
If you are not sure whether Blueprint Genetics has a test for your patient or what would be the optimal test for your patient, please first review our diagnostic panels in the website top bar menu under ‘tests’ where each panel is shortly described including a list of covered genes and regions within each gene, analytic performance and potential limitations. If the phenotype is partly unclear and you are still unsure which test to pick up, send us a consultation preferably by email or phone (see contact section). Please do not insert patient’s name or social security number (or equivalent) in emails. Customer will be advised by email within 24 hours from the request.
Results and Analysis
Why are the results of testing sent directly to the referring physician rather than the patient or parent of a patient?
Genetic testing is usually performed as a tool to help the physician make a diagnosis and thus improving risk assessment, prevention and treatment strategies for the disease. Results of genetic testing are sometimes complicated and difficult to understand, so that special knowledge is essential in order to explain the consequences of the test outcome. Results of genetic testing may lead to immediate change of life style, treatment or need of additional testing, which all need to be explained to the patient by his/her physician to make sure that the final decisions are done by an expert who knows all aspects of the patient’s situation.
The test results have been lost or were never received. Can you resend them?
Results are available for the ordering physician at our online reporting system, where copies can be taken. We cannot send results to the patient or other physicians who were not registered in our system when preliminary order was done without a signed release from the ordering physician authorizing us to do so. When asking a new report, please contact our customer service.
I received an email saying that the test results are ready. How can I see them?
You can access the results by our ordering and reporting system, Nucleus. We send login details by email to all of our unregistered customers after they have placed an order. If you can’t find/remember your password, you can order a new one using the “Forgot password?” link. If you asked for the results to be sent by regular mail, they are sent to you via priority mail the same or the following business day after the notification email. If you asked for the results to be faxed to you, they are faxed the same or the following business day after the notification email.
How do I know that my test results are ready?
Our tests take normally 21 days to complete. Your physician can track the laboratory process from our online system. As soon as a test is completed, your physician will be notified by email that your test results are available at our online reporting system.
Which buffer should I use to extract the DNA?
TE buffer is often used. Other options are nuclease free water or elution buffer provided by standard DNA extraction kits.
What kind of patient samples do you accept?
So far, we accept the following sample types:
- EDTA blood, min. 1 ml
- Purified DNA, min. 5μg*
- Saliva (Oragene DNA OG-500 kit)
* If DNA concentration is measured using fluorescence based DNA quantification method such as Qubit, 5 µg of DNA would be enough, but when the measurement is done using spectrophotometric methods two times higher amount is needed due to likely overestimation of true amount. If our DNA quality and quantity control show that customer has provided DNA less than needed, it will delay testing due to need for additional sample material before analysis can be initiated.
For Whole Exome tests, sample requirements are:
- EDTA blood, min. 2 ml
- Purified DNA, min. 10μg*
- Saliva (Oragene DNA OG-500 kit)
When Whole Exome Family or Whole Exome Family Plus product is ordered, we require to send samples from first-degree relatives of the index patient at the start of testing.
We do not accept DNA samples isolated from formalin-fixed paraffin-embedded (FFPE) tissue.
Contact customer support if you are wishing to send any other material. It is mandatory that customer notifies Blueprint Genetics if patient has received bone marrow transplant due to risk of misinterpretation when analyzing blood or saliva samples as starting material for the analysis.
If more than one test is being ordered from the same patient, is it better to provide a new tube of blood for each test?
There is usually no need for another sample. Blueprint Genetics obtains enough DNA from one sample to complete a number of tests. In case we run out of sample material, you are contacted by our customer support.
How should samples be collected, labeled and stored before shipping?
Blood sample should be collected to an EDTA tube designated for blood samples. The tube should be labeled with patient name, date of birth and date of sample collection. Ideal is to send the sterile blood sample as soon as possible after sample collection. It can be sent in ambient temperature. Overnight shipment is recommended. In hot weather a cool pack should be enclosed. If storing of the sample is the only option, the blood sample can be refrigerated for a couple of days before shipment. For longer storage the sample should be frozen. The yield and quality of isolated DNA determines whether the sample can be analyzed. Blood specimens will be rejected if hemolyzed or clotted. Blood is accepted for all tests except if the patient has ever received a heterologous bone marrow transplant. We recommend using transport tubes in accordance with IATA regulations 650.
DNA samples should be sent either in nuclease free water or any standard elution buffer used in DNA isolation. Sample tube should be labeled with patient name, date of birth, DNA concentration and volume. The sample can be sent in ambient temperature. If the sample needs to be stored before shipment, it can be refrigerated for a couple of days. For longer storage the sample should be frozen. The quality and quantity of DNA will be tested at arrival at Blueprint Genetics and the customer will be asked to send a new sample if the DNA quality or quantity is not sufficient for the analysis. We recommend using transport tubes in accordance with IATA regulations 650.
Sample tube should be labeled with patient name, date of birth and date of sample collection. Collect the sample according to the manufacturer’s instructions to the tube provided in the kit. Samples not collected properly (e.g. sample is mainly mucus not saliva) will be rejected. The sample can be stored and sent in ambient temperature.
Where do I send the sample?
US, Canada and South America
1250 Missouri Street, #208
San Francisco, CA 94107
Europe, Middle East, Asia and Australia
Tukholmankatu 8, Biomedicum 2U
How do I send the sample?
Sending samples by using the Specimen kit
Follow the orders and use the packing materials provided in the kit.
Sending samples without the kit
An express courier service should be used for sending blood samples from outside the Nordic countries. Blood samples can be sent in ambient temperature if overnight shipping is used. Blood samples fall under Biological substance category B (UN3373) and should be packaged and sent according to IATA 650 guidelines. The primary receptacle (=tube) needs to be leak proof and should be placed into a leak proof secondary package (e.g. sealed plastic bag or falcon tube) with some absorbent material. The secondary package should then be placed into a rigid outer package. The outer package needs to include the text “Biological Substance, Category B” next to a diamond-shaped UN3373 label.
DNA samples can be sent either via an express courier service or regular mail depending on your country’s postal service and their regulations. They can be sent in ambient temperature if express shipping is used. DNA samples are considered noninfectious and can be sent as exempt human specimens. They should however be packaged in a triple package. The primary receptacle (=tube) needs to be leak proof and should be placed into a leak proof secondary package (e.g. sealed plastic bag or falcon tube) with some absorbent material. The secondary package should then be placed into a sturdy outer package. The outer package needs to include the text “Exempt human specimen”.
Saliva samples can be sent either via an express courier service or regular mail depending on your country’s postal service and their regulations. They can be sent in ambient temperature. Saliva samples are considered noninfectious and can be sent as exempt human specimens. They should however be packaged in a triple package. The saliva tube should be placed into a leak proof secondary package (e.g. sealed plastic bag or falcon tube) with some absorbent material. The secondary package should then be placed into a sturdy outer package. The outer package needs to include the text “Exempt human specimen”.
Does Blueprint Genetics pay for shipping?
When using our Specimen Kit, the shipping has been prepaid by Blueprint Genetics. For sending samples without the specimen kit, contact our customer support (support(at)blueprintgenetics.com).
Can I send samples in ambient temperature?
Blood, DNA and saliva samples can be sent in ambient temperature. Express shipping should be used for blood and DNA samples. Blood samples collected on a Friday evening or over a weekend should be kept in the refrigerator and shipped on the next business day for overnight delivery. Keeping the specimen refrigerated over the weekend will not compromise the quality of the specimen.