Specimen and shipping requirements

Accepted for the following test types:

• Diagnostic testing (panels and exome)
• Genetic risk panels
• Parental/familial studies
• Pediatric microarray analysis
• Personalized cancer monitoring

Specimen types accepted:

• Whole blood (find phlebotomy sites in the US and Canada here)
• Cord blood, collected at birth (but not prior to birth; we recommend that you perform MCC analysis if you have concerns about maternal cell contamination for a given specimen)
• Frozen or partially frozen blood, although deletion/duplication analysis is not guaranteed for these specimens; also note that these specimens will be thawed upon receipt

We are unable to accept:

• Hemolyzed or clotted blood
• Blood, saliva, assisted saliva, and buccal swabs from patients who have had an allogeneic (non-self donor) bone marrow transplant
• Blood, saliva, assisted saliva, and buccal swabs from patients who have had an allogeneic (non-self donor) stem cell transplant
• Blood, saliva, assisted saliva, and buccal swabs from patients who had a blood transfusion containing leukocytes less than two weeks prior to specimen collection. Specimens from individuals who have received transfusions of packed red blood cells, plasma or platelets are acceptable, however the likelihood of failure to produce a test result may be higher if the white blood cell concentration in the specimen is reduced.
• Blood, saliva, assisted saliva, and buccal swabs from patients who have had a liver transplant.
• For personalized cancer monitoring testing only: we are unable to accept specimens from patients with active hematological malignancy, history of allogeneic bone marrow/stem cell transplants, or within 2 weeks of blood transfusion.

Hematologic conditions:
Results may be affected for specimens from patients with certain hematological conditions that are actively circulating in the peripheral blood. In such cases, a specimen type that does not contain leukocytes is suggested, such as gDNA extracted from cultured fibroblasts obtained via a skin biopsy. Please see the “Specimens for patients with hematological conditions” section on this page for more information.

For adults:

• We require a minimum of 3 mL of whole blood per clinical area for adults.
• We require a minimum of 3 mL of whole blood for personalized cancer monitoring testing.

For pediatric cases:
We prefer 3 mL per clinical area, but can accept 1.5 mL if necessary.

For newborns/infants:
We accept small-volume microtubes (0.5-mL capacity) from capillary blood collection (heel or finger stick). We require 3 full small-volume tubes per clinical area.

For pediatric microarray cases:

• 4 mL blood in an EDTA (purple top) tube
• For NICU/PICU patients, minimum 1-2 mL per tube

For cytogenetic parental/familial studies (microarray):
4 mL blood in an EDTA (purple top) tube

• Diagnostic, genetic risk, and parental/familial samples should be sent in EDTA (purple-top or pink-top) tubes. We accept both K2EDTA and K3EDTA.
• Pediatric microarray should be sent in EDTA (purple top) tubes
• Personalized cancer monitoring samples should be sent in EDTA (purple top) tubes only
• Please see the post-mortem specimens section for details on gray-top tube specimens.

For diagnostic and genetic risk testing, each tube must be labeled with:

• The patient’s full name
• One additional unique identifier: Date of birth, Medical record number, IB number (if placed by submitting clinician), Invitae test order ID (RQ#)
• Specimen collection date

The patient name and at least one additional unique identifier written on each tube must match the name and identifier provided when the test order was placed. We recommend including more than one additional unique identifier to ensure a match.

For pediatric microarray and parental/familial studies label with the following information:

• Specimen collection date
• Patient’s sex
• Patient’s date of birth (MM/DD/YYYY)
• Patient’s full name, including legal first and last name

For personalized cancer monitoring testing, each tube must be labeled with:

• The patient’s full name, including first and last name
• Patient’s date of birth (MM/DD/YYYY)
• Specimen collection date

Unlabeled tubes will not be accepted for processing. If you are utilizing your own label, please ensure not to cover the IB barcode on the existing tube label.

We recommend using overnight shipping the same day that the blood is collected.

• Blood can be kept at room temperature for up to 48 hours.
• We request that blood is refrigerated no longer than two weeks.
• Please do not freeze blood as deletion/duplication analysis is not supported for frozen or partially frozen blood.
• For personalized cancer monitoring testing: Frozen blood specimens are NOT acceptable

For diagnostic and genetic risk testing:

• A printed copy of the requisition form must be submitted with the specimen if you're not placing your order through the online portal. You can find and print a copy of the requisition form here.
• If you're placing an online order, a printed copy of the requisition form is helpful but not required.
• Please note that notes handwritten on the form will not be processed.
• If you need to modify your order, please contact Client Services.

For pediatric microarray, personalized cancer monitoring, and parental/familial studies:

• A printed copy of the requisition form must be submitted with the specimen. You can find and print a copy of the form here.
• If you need to modify your order, please contact Client Services.

When shipping samples, please follow the IATA regulations:

Please note that Invitae sample collection kits are built to protect the samples from being damaged during transport and to comply with the International Air Transport Association (IATA) regulation. If you are using packaging other than that provided by Invitae, please make sure to follow the "three layers of packaging" rule to avoid the risk of having the package destroyed by the courier:

• A primary sample receptacle sealed (collection tube)
• A leak-proof specimen bag containing absorbent material
• An outer packaging that meets the local postal regulations and is labeled as “Exempt Human Specimen.”

For more information please refer to page 187 of IATA Dangerous Goods Regulation.

For diagnostic and genetic risk testing:

Blood should be shipped overnight at room temperature. We recommend including cold packs when shipping from outside the US and Canada in hot weather or if shipping is expected to take longer than overnight to keep the specimen at 2 to 8 degrees Celsius (35.6 to 46.6 degrees Fahrenheit). Frozen blood should be shipped overnight using cold packs.

To assist with specimen collection and shipping, you can request a free Invitae blood collection kit by submitting our online Request a Kit form.

If you are sending more than one kit in a given day to Invitae, you can include up to four kits into the same FedEx Clinical Pak envelope for your convenience. If multiple kits do not fit well into a single envelope for any reason, please separate them into as many envelopes as needed.

Alternatively, you can send us the specimen in a crush-proof container via FedEx Priority Overnight (in accordance with the FedEx Packaging Guidelines for Clinical Samples. Please contact Invitae’s Client Services team to obtain the FedEx account number. (Pricing includes return shipping when sent from the US and Canada)

• Invitae accepts packages Monday through Friday. We recommend that you send your package so that it leaves your facility Monday through Thursday. Please do not request Saturday delivery. Invitae follows the FedEx Holiday Service Schedule.
• If you ship your specimen from outside the United States, your shipping carrier will require three copies of a commercial (pro-forma) invoice. A sample invoice is available here. Please be sure to also include a customs declaration form. A sample customs declaration form is available here.

For personalized cancer monitoring testing:

Blood should be shipped overnight at room temperature 18°–30°C (65–86°F). We recommend including cold packs when shipping from outside the US and Canada in hot weather or if shipping is expected to take longer than overnight to keep the specimen at 2°–8°C (36°–46°F).

To assist with specimen collection and shipping, contact Invitae to request a free collection kit.

Shipping Address:
Invitae Accessioning Dept
485F Route 1 South, Suite 110
Iselin, NJ 08830
p: (732) 652-8000

• Invitae’s New Jersey lab accepts packages Monday through Friday. We recommend that you send your package so that it leaves your facility Monday through Thursday. Invitae follows the FedEx Holiday Service Schedule.
• If you ship your specimen from outside the United States, your shipping carrier will require three copies of a commercial (pro-forma) invoice (a sample invoice is available here). In addition to the Air Waybill, Invitae provides 3 copies of a proforma invoice and a customs declaration form (a sample customs declaration form is available here).