Galleri

GRAIL makes the Galleri multi-cancer early detection test. GRAIL ships a sealed specimen collection kit that the patient can bring to the draw. ^[G1]

Galleri looks for signals from cell-free DNA (cfDNA) in the blood. The kit's Streck tubes contain a preservative that stabilizes blood cells and protects the cfDNA for testing. ^[G2] Ask your provider about what the result covers.

1. 1

   Before the visit

   Prep

   • GRAIL does not publish fasting or medication rules for the draw. Follow the instructions in your kit. Check that the kit has not expired before your appointment. ^[G1]
2. 2

   The draw

   Draw

   • From GRAIL's "Labeling and collecting a specimen" guide: ^[G1]
   • Label both tubes before the draw: full legal name, date of birth, biological sex, and MRN if applicable. Align the red dot on the label over the red owl icon on the tube. Do not put any other labels on the tube.
   • Put the TRF label on the requisition in the "GRAIL ID" field.
   • Verify the patient's identity. Use a 21 or 22 gauge needle.
   • If using a butterfly set, partially draw an EDTA discard tube first to clear air from the tubing.
   • Prevent backflow: keep the arm pointing down, hold the tube stopper up so the contents don't touch the stopper or needle, and release the tourniquet once blood flows or within 2 minutes.
   • Fill two Streck tubes with 10 mL each. If 10 mL isn't possible, each tube needs at least 3 mL.
   • Draw directly into the Streck tubes. Transferring blood from a syringe or another tube is not allowed.
   • Order of draw: follow CLSI GP41. Streck's guidance in the kit insert says draw it after EDTA and before fluoride oxalate. ^[G2]
3. 3

   Right after collection

   Processing

   • Gently mix with 10 complete inversions. ^[G1]
   • Do not spin. Do not refrigerate or freeze. ^[G1]
   • Store at room temperature, 6 to 37 C. GRAIL must test the sample within 7 days of collection. ^[G1]
4. 4

   Get it to the lab

   Shipping

   • From GRAIL's standard kit instructions: ^[G2]
   • Seal the tubes in the biohazard bag with the absorbent pad.
   • Put the bag inside the folded gel pack in the foil pouch, then seal the pouch. Do not refrigerate or freeze the gel pack.
   • Put the pouch in the box with the completed paper TRF (if used) on top. Seal the box with the return seal.
   • The prepaid label is already on the bottom of the box. Ship the same day as collection and check your local pickup cutoff so it arrives next day.