Laboratory information
Licensing & Locations
California
Menlo Park (MPK)
1525 O’Brien Dr
Menlo Park, CA 94025
CLIA Certificate of Accreditation: 05D2154430
The College of American Pathologists (CAP): 8149563
California Department of Public Health: CDF-00352665
Maryland Department of Health Permit: 3204
Rhode Island Department of Health License: LCO01503
New York State Department of Health Permit: PFI-9558
Pennsylvania Department of Health Permit: 38399
North Carolina
Research Triangle (RTP)
4001 E NC 54 Hwy Assembly Suite 1100
Durham, NC 27709
CLIA Certificate of Accreditation: 34D2231294
The College of American Pathologists (CAP): 9151388
California Department of Public Health: CDS-90007074
Maryland Department of Health Permit: 3526
Rhode Island Department of Health License: LCO01562
New York State Department of Health Permit: PFI-9711
Pennsylvania Department of Health Permit: 39687
Hours of Operation
Customer Service Hours:
Monday – Friday: 5:00 AM – 5:00 PM PST
(833) 694‑2553
Turnaround time
The turnaround time (TAT) for results of the Galleri® test is about 2 weeks from the time a specimen is received at the laboratory for processing. Shipping to the laboratory typically takes 1 to 2 business days.
For example, if a specimen is picked up by FedEx on a Monday, the laboratory will receive it on a Tuesday. Allowing for about 2 weeks, the report can be expected by the end of the second Tuesday after the Monday the specimens were submitted.
Logistical factors beyond the control of the laboratory can affect the time between blood draw and results reporting and are considered exceptions to the about 2 week turn-around time commitment. These cases may include but are not limited to:
Delays in shipping specimens from a customer’s location or a missed FedEx pickup.
Logistical delays that occur during transport of the specimen to the laboratory, or
Unforeseen disasters that significantly impact laboratory operations.
In an event where the stated turn-around time cannot be met, you will receive a phone call from GRAIL Customer Service, which will provide the reason for the delay and a new estimate for when the test results will be reported.
Holiday schedule
Only schedule blood draws when blood can be shipped to the laboratory within 24 hours of the time of collection. GRAIL will issue guidance for “Do Not Ship” dates, which should be observed in order to minimize transit times and maintain specimen integrity. Generally, these are days when FedEx is not operational due to holiday closures. GRAIL Customer Service will notify your facility in advance of these dates.
How we track Galleri specimen collection kits in transit
Once your package has been received by FedEx, the information immediately appears in GRAIL’s Laboratory Information Management System, or LIMS. Our logistics team uses this tracking information to trace the shipment from the time it’s received by FedEx to the time it’s delivered to the laboratory.
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Cancer Signal Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g. imaging) to confirm cancer.
If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.