US laboratory operations frequently asked questions

General

What is happening?

Effective August 15, Blueprint Genetics will transition laboratory services to our global headquarters and laboratory in Helsinki, Finland and discontinue testing specimens in Marlborough, MA. Blueprint Genetics will continue to offer genetic test services for you and other US-based customers through our Helsinki lab.  All samples received at our US lab after August 15, with the client’s permission, will be forwarded, processed, and resulted from our laboratory in Helsinki, Finland. Starting August 15, we can only accept institutional billing orders.

 

What is the reason for the transition?

Our Helsinki laboratory is our largest facility where we service clients worldwide and a location where we can centralize innovation and expertise.

 

I would like to continue to use Blueprint for US genetic testing needs. What do I do?

Please fill out the request form above to have your laboratory services agreement (LSA) amended, acknowledging that your samples will be processed in Helsinki, Finland and that Blueprint Genetics will bill you according to our institutional billing practices, in US dollars.  Upon receipt of this form, our team will contact you to create or amend your laboratory services agreement with Blueprint Genetics.

Following this, our team will create a NEW Nucleus account for your future orders in the Global Nucleus. You will receive an email with your new account credentials and instructions for logging in.

 

Ordering

I have an in-process order.  Will you still be resulting that order?

Any orders received that have entered processing before August 15 will still be processed and resulted in our US laboratories. You can log into your US Nucleus account to check the status of those orders. While we will stop processing NEW samples and orders received starting August 15, we will continue to result all orders in analysis from the US laboratory in our expected turnaround time, which is currently approximately 8-9 weeks.

 

I have an open order that is on hold because the sample has not been sent by the patient or an issue is holding up processing.  Will this order still be processed?

Any orders for which samples have not been received or that have outstanding issues will be canceled at the close of business on August 15. You can place a NEW order for your patient after you have filled out the LSA request form and our team has created a Global Nucleus account for you.

You can find the LSA request form here: https://blueprintgenetics.com/us-lab-operations/

 

Will I still be able to use my current US Nucleus account?

Your US Nucleus account will stay active so that you can access previous orders and results.  However, you will no longer be able to place new orders using this account.  To place new orders to be processed in Helsinki, Finland you will need to fill out the LSA request form on our website acknowledging that your samples will be processed in Helsinki and that Blueprint will bill you according to our institutional billing process in the US. Upon receipt of your signed form, our team will contact you for next steps.

 

Do I need to request a new account for the global instance of Nucleus?

You can request that your existing account information be transferred into a Global account by visiting our website and filling out the laboratory services agreement request form. Once the LSA has been updated, our team will create a NEW Global Nucleus account for your future orders. You will receive an email with new account credentials and instructions for logging in once this request has been approved.

 

How do I place an order once I am set up with a new global Nucleus account?

You can place future orders via Nucleus; just make sure you are in the correct instance of Nucleus: https://nucleus.global.blueprintgenetics.com.

Alternatively, you can place an order via a paper requisition form by sending it to us with the sample or via land mail or fax at +1 (650) 446-7790.

Send paper requisitions to:

Blueprint Genetics

Keilaranta 16 A-B,

02150 Espoo

Finland

 

For clients who are ordering the My Retina Tracker Panel for individuals affected by inherited retinal disease:

As of July 26, 2024, the My Retina Tracker Program will no longer be available through Blueprint Genetics.  All My Retina Tracker orders must be fully submitted in US Nucleus on or before July 25, 2024. Patient samples and consent forms submitted for My Retina Tracker orders must be received by Blueprint Genetics no later than August 16, 2024. Any My Retina Tracker orders missing required components as of August 16, 2024, will be canceled.

 

Client services requests

How do I get in touch with a client services representative?

While testing will be performed in our Helsinki laboratory, you will continue to be serviced by our US client services team. Feel free to use our contact form on the website, https://blueprintgenetics.com/contact/ , email us at support.us@blueprintgenetics.com, or, if you need assistance, call us at 1.650.452.9340 ext. 0.

 

Will I still be able to get copies of previous reports or raw data?

Yes. Reports will still be available through your US Nucleus accounts. Raw data can also be requested on previous orders processed in the US. You can email us at support.us@blueprintgenetics.com or call us at +1.650.452.9340 ext. 0. We are happy to assist you.

 

Shipping

How can I order kits?

You can continue to order specimen kits from our website and from Global Nucleus or by contacting us directly via email at logistics.support@blueprintgenetics.com.

To order new kits from our website, please visit: https://blueprintgenetics.com/order-kit/.

 

How will this affect shipping times for kits arriving at our facility and for you to receive the sample?

We are continuously working with our courier partners to ensure a smooth transition to and from our facility. We cannot guarantee a specific shipping time but expect the shipments to arrive within 2-3 days.

 

Can we still send samples to the US lab? 

Yes, you may use kits with the US lab address you have in stock. Samples shipped to the US lab will be forwarded to our facility in Helsinki if we have received your consent through a signed laboratory services agreement.  If samples are received without consent to forward to Helsinki, we will contact you.

Our US sample shipping address remains:

200 Forest Street

2nd Floor

Marlborough, MA 01752

United States

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I recently sent a patient’s sample to the US laboratory. What will happen to the sample? Am I able to request the sample to be returned?

For new tests, you may choose to proceed with testing of the sample at our Helsinki laboratory, have the sample returned to you, or have the sample disposed.

If you would like to proceed with testing of the sample at our Helsinki laboratory, please fill out the request form to have your laboratory services agreement (LSA) amended, acknowledging that your samples will be processed in Helsinki, Finland and that Blueprint Genetics will bill you according to our institutional billing practices, in US dollars. Upon receipt of this form, our team will contact you to create or amend your laboratory services agreement with Blueprint Genetics.

Following this, our team will create a NEW Nucleus account for your future orders in the Global Nucleus. You will receive an email with your new account credentials and instructions for logging in.

If you wish for the samples to be returned to you, please reach out to our client services team. If you do not request your sample to be returned nor for us to proceed with the testing at our Helsinki laboratory, we will dispose of the sample 30 days after arrival.

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Can I send samples directly to Helsinki?

If you would like to ship directly to our facility in Helsinki, you are welcome to do so. If your institution has a courier account with international shipments enabled, we can share detailed instructions to ensure the shipping labels and other customs documents are correctly completed. Our logistics team is also readily available for further assistance if required.

The shipping address for our Helsinki facility is:

Blueprint Genetics

Keilaranta 16 A-B

02150 Espoo

Finland

 

If I choose to send samples directly to Helsinki, what customs documentation is required to ensure smooth transit?

A valid shipping label and a customs invoice are required for all international shipments. These are to be filled in correctly and included with the shipment. To ensure a smooth transit of shipments from the US to Finland, please ensure that the following information is included:

  • Blueprint Genetics EORI number: FI22307900
  • HS code for the items included in the package
    • DNA SAMPLE: 3824 99 92 99
    • Saliva SAMPLE: 3001 90 20 00
    • Blood SAMPLE: 3002 90 10 00
  • Value for customs for the items included in the package; this is up to you to determine, but we recommend 5 USD per sample
  • Description of the items included in the package, for example: Exempt human specimen
  • Country of manufacture of the items included in the package, for example: United States

Our team regularly monitors incoming shipments and is alerted should there be any issues along the way. Should a package be held at customs, we will work with our courier partners and you, if necessary, to get the shipment released.

 

How can I request a return label only? (using own packaging)

You may send a request for a return label only by emailing us at logistics.support@blueprintgenetics.com. Please include the following information:

  • Courier preference (FedEx or DHL)
  • Sender’s name
  • Sender’s address
  • Sender’s phone number
  • Sender’s email address
  • Number of samples
  • Sample type (saliva/blood/DNA)
  • Package information (estimated weight and dimensions, if possible)
  • Any preference regarding the pickup (date/time slot/additional information for the courier)

We will create the label and customs invoice for you and send it via email.

 

Sample stability

Will longer shipping times/customs hold affect the stability of the sample?

There shouldn’t be any significant effect on sample stability.

 

Testing

After this transition, will any of the products or services offered by Blueprint Genetics change?

Yes, there will be a few changes to the offering. Please see below for more information.

Gaining:

  • Improved Whole Exome Sequencing
    • Our Whole Exome products (singleton and family) have improved performance, with the whole mitochondrial genome and almost 2000 clinically relevant noncoding variants.
    • The improved WES will not be available for order via Nucleus right away, but you may order using our Whole Exome paper requisition form for the time being.

No changes:

  • Panels
  • Single gene tests
  • Variant specific testing:
    • Familial variant testing where the index patient is tested at the Helsinki laboratory
    • Targeted variant testing
  • Raw data ordering
  • Sample return
    • For samples already tested at the US laboratory
    • For samples tested at the Helsinki laboratory

Slight changes with limitations:

  • Familial Variant Testing where the index patient was tested at the US laboratory
    • Family members can still be tested under Familial Variant Testing in the Helsinki laboratory, but if the index patient was tested at the US laboratory, limitations apply. Please contact our support team for more information.
  • WES Re-analysis
    • WES re-analysis cannot be performed at the US laboratory. Therefore, if a WES re-analysis is requested, a new WES order is placed in the Global Nucleus portal and the sample sent to Helsinki.
  • Variant Re-evaluation Service
    • The Variant Re-evaluation Service is not available for orders previously completed at the US laboratory. However, this service will be available for future orders placed in the Global Nucleus and analyzed at the Helsinki laboratory.

Discontinued

  • VUS Clarification Service
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I do not see Whole Exome test available in my Global Nucleus account? Can I still order it?

The Whole Exome products will not be visible to US clients in Global Nucleus right away, due to product improvements including the addition of the whole mitochondrial genome and up to 2000 clinically relevant noncoding variants. We are currently working on making online ordering of Whole Exome tests available in our Global Nucleus for US clients as soon as possible.

 

What is the turnaround time for testing?

Turnaround time for panels, VSTs, and singe gene products is approximately 4 weeks. Turnaround time for whole exome products is approximately 6 weeks.

 

Where can I find a list of products and services offered by the Helsinki Laboratory?

At our website, www.blueprintgenetics.com.

 

Can I request that a sample that has previously been tested at Blueprint Genetics be used again?

Unfortunately, due to the complexity of cross-border compliance regulations, we do not recommend reusing samples for testing being performed at Blueprint Genetics in Helsinki that have already been tested at Blueprint Genetics in the US and are stored in the US.

If you have a circumstance in which the collection of a new sample is unreasonable, such as for deceased patients, please reach out to our client services team to see if there is a potential work around this issue. Email us at support.us@blueprintgenetics.com or call us at 1.650.452.9340 ext 0.

 

Can I order an exome reanalysis for an exome that was performed at our US laboratory?

Yes, however, we will need a new sample from the patient.  Please contact us to discuss the specifics of your case.

 

I order sponsored testing through Blueprint Genetics; can I continue to order this test?

For clients who are ordering NovoDETECT™ testing to help diagnose your patients’ early onset or recurrent kidney stones, this program will continue to be sponsored. Eligible patients will receive testing at no-charge through our laboratory in Helsinki. You can continue to send the samples to our US laboratory using the kits you already have in-house.  The laboratory will route the samples to our Global Laboratory in Helsinki, Finland.

To continue ordering NovoDETECT™ sponsored testing, our team will create a NEW Global Nucleus account for you. You will receive an email with new account credentials and instructions for logging in. For orders and samples received after August 15, the orders will be placed under your NEW account in the Global Nucleus.

If you have open NovoDETECT™ orders currently under your account in US Nucleus (Waiting for Sample) and the sample is received at the US laboratory after August 15, our team will copy the order over to your NEW Global Nucleus account and redirect the sample to our Global Laboratory in Helsinki, Finland.

Once your NEW Global Nucleus account is created, please continue to order the program panels in the Global Nucleus:

  • 3-gene NovoDETECT™ Primary Hyperoxaluria panel
  • 45-gene NovoDETECT™ Nephrolithiasis panel

If you are ordering with a paper requisition, you may send in your order as before, and our team will contact you to set up your NEW Nucleus account for this and future orders upon processing your paper requisition.

 

Will Familial Variant Testing be available in the Helsinki laboratory even if testing of the index patient has already been performed in the US laboratory?

Yes, with limitations. Please note that these limitations only apply to Familial Variant Testing orders where the index patient and family members are tested at different Blueprint Genetics laboratories (index patient has been tested at the US laboratory and the family members are tested at the Helsinki laboratory).

Unfortunately, due to cross-border compliance and patient privacy regulations, it is not possible for the Helsinki laboratory to access the sequencing data nor the original order of the index patient. Therefore, when placing the Familial Variant Testing order in Global Nucleus, the order for the index patient is not recognized and cannot be connected to the family member’s order. This means that you will need to add the familial variants manually.

Due to these limitations, we are unable to perform the Familial Variant Testing in Helsinki for mitochondrial variants, CNVs, or prenatal samples, where the index patient has been tested at the US laboratory.

Furthermore, after Familial Variant Testing has been performed in Helsinki, we are unable to update the index patient’s report in US Nucleus with the additional information acquired from the segregation analysis, such as updates to the variant classification or mentions of the inheritance or phase of the variants (de novo, in cis, in trans).

 

Can I request a Variant Re-evaluation for a test that was performed at our US laboratory?

No, we are unable to provide updated reports for your previous orders. Our Variant Re-evaluation Service has been discontinued.

If you wish to test your patient again to receive the most up-to-date variant evaluation, please place a new order for the patient in the Global Nucleus and send a new sample to the Helsinki laboratory. Please note that, in this case, there will be a fee for the new test.

For orders placed in the Global Nucleus where the samples have been analyzed at the Helsinki laboratory, the Variant Re-evaluation Service is available as before.

 

My patient had a Variant of Uncertain Significance (VUS) reported with a recommendation for the VUS Clarification Service. Is my order still eligible for the VUS Clarification Service in Helsinki?

No – unfortunately, due to compliance regulations and technical limitations, we are unable to continue our VUS Clarification Service at the Helsinki laboratory.

On the other hand, our Familial Variant Testing is essentially the base of our VUS Clarification Service and provides the same service but with a fee, including variant reclassifications and segregation analysis. Indeed, if the index patient has been tested at the US laboratory and the family members are tested at the Helsinki laboratory, limitations apply (please see additional information regarding our Familial Variant Testing service here).

 

Will my results from previous orders analyzed in the US get updated/how do I get updated results?

No, due to compliance regulations and technical limitations, we are unable to provide updated reports for your previous orders analyzed in the US.

We are deeply apologetic for this limitation in our services and hope to provide you and your patients with as much valuable information as we can. Please do not hesitate to reach out to our support team at support.us@blueprintgenetics.com with any questions or concerns that you may have.

 

Billing

Will there be a change in pricing for Blueprint Genetics tests?

Following the transition, there will be slight changes to our pricing. Updated pricing will be included in your signed laboratory services agreement. Please note that all pricing is now institutional billing, since we will no longer be billing third-party insurance.

 

What payment options are available?

The primary payment method offered is wire transfer to Finland. Please note that we will not be able to accept check payments.

For questions about institutional billing, please contact billing support at billing@blueprintgenetics.com

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If I have questions regarding my invoice, who should I contact?

Moving forward, billing@blueprintgenetics.com will be the primary contact for any billing-related questions.

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Will there be a change in pricing for Blueprint Genetics tests?

Following this transition, there will be slight changes to our pricing model. The updated prices will be included in your signed laboratory services agreement. Please note that all pricing is now institutional billing since we will no longer be billing third party insurance or direct patient pay.

 

Which payment methods are accepted for institutional billing?

The primary payment method offered is direct bank transfer. (Please note, if you wish to pay by credit card a possible additional fee will be added.)

For questions about establishing an institutional billing account, please contact billing support at billing.@blueprintgenetics.com.

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Privacy

Will the Helsinki laboratory now have access to my patient’s information?

Blueprint respects the patients’ privacy and applicable privacy regulations. Hence, there will not be access to US patient PHI from the Helsinki laboratory, and only strictly necessary data required for Blueprint to be able to provide the ordered services will be processed.

 

What will happen to my patients’ samples tested and stored at the US laboratory?

For completed tests, the samples will continue to be stored as defined in our General Terms or as consented by the patient.

If you wish for the samples to be returned to you (or if you wish for the samples to be disposed), please contact us at support.us@blueprintgenetics.com with your request.