Key facts
- The test covers PRNP only; its order name is PRNP Single Gene Analysis and the catalogue CPT code is 81404.
- Method is next-generation sequencing for single nucleotide variants, insertions, deletions and copy number variants, with reportable variants confirmed by validated orthogonal methods as needed.
- Turnaround is 10 to 21 days from specimen pickup to release of the result to the ordering provider, with extra time possible for confirmatory or reflex testing.
- Orders must include an attestation that the provider holds the patient's informed consent for genetic testing.
- Accepted specimens are EDTA whole blood (4 mL preferred, 3 mL minimum), an Oragene Dx 500 saliva kit, two ORAcollect Dx buccal swabs, or extracted gDNA (5 ug at 50 ng/uL or higher).
- Blood is stable for 90 days, saliva and buccal for 60 days at room temperature; blood, saliva and buccal samples must not be frozen.
- Specimens are rejected if hemolyzed, too small, in the wrong container or temperature, or from a person who has had an allogeneic bone marrow transplant.
- The test does not detect germline mosaicism, repeat expansions, large rearrangements or variants in other genes, and variant classification can change over time.
- Labcorp states the test was developed and validated by Labcorp and is not FDA cleared or approved.
- Labcorp's bid for select Invitae assets was approved by the bankruptcy court and announced on 7 May 2024, at USD 239 million cash plus other consideration.
- Labcorp announced completion of the acquisition on 5 August 2024 and said it would combine Invitae technology with its specialty testing in oncology and select rare diseases; no individual tests were named.
Timeline
- 2024Invitae enters Chapter 11 in the US Bankruptcy Court for the District of New Jersey (reported in search results only).
- 2024Labcorp announces court approval of its bid for select Invitae assets.
- 2024Labcorp announces it has finalized the acquisition.
- 2026Labcorp catalogue page for test 900141 carries a 2026 copyright year; no revision date is shown.
Last checked 1 November 2026