(CTC) Pain Management, CYP450 3A4 Genotype, Qualitative

Test Code

70500

Physician Attestation of Informed Consent

This germline genetic test requires physician attestation that patient consent has been received if ordering medical facility is located in AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD or VT or test is performed in MA.

Preferred Specimen

4 mL Whole blood.

Collection Instructions:
__Whole Blood: Normal phlebotomy procedure; specimen
__stability is crucial. Store and ship ambient immediately.
__Do not freeze.
__
__Saliva: Use only DNA Genotek Oragene-Dx (OGD-510) kit.
__Follow instructions. Store and ship ambient or
__refrigerated. Do not freeze.
__
__Buccal swab: Use only Celera/Copan DNA collection kit
__(Celera part# 5002737). Store and ship ambient only. Do
__not refrigerate or freeze.

Minimum Volume

Whole blood: 2 mL
Saliva: 1 mL

Other Acceptable Specimens

2 mL Saliva
Buccal swab

Transport Container

Whole blood
__EDTA (lavender-top) (preferred)
__ACD solution A (yellow-top)
__ACD solution B (yellow-top)
Saliva: See collection instructions
Buccal swab: See collection instructions

Transport Temperature

Whole blood, Saliva and Buccal swab: Room temperature
_preferred; Refrigerated See instructions; Frozen See
_instructions

Specimen Stability

Whole blood
__Room temperature: 8 Days
__Refrigerated: 8 Days
__Frozen: Unacceptable
__-70 Degrees: Unacceptable
Saliva
__Room temperature: 14 Days
__Refrigerated: 14 Days
__Frozen: Unacceptable
__-70 Degrees: Unacceptable
Buccal swab
__Room temperature: 14 Days
__Refrigerated: Unacceptable
__Frozen: Unacceptable
__-70 Degrees: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Incorrect collection device, Liquid has leaked from
container/no liquid present, Blood sample received frozen,
Buccal swabs received refrigerated or frozen

Methodology
Single Nucleotide Primer Extension

Setup Schedule

A.M. Sets up 1 day a week.

Report Available

Reports in 9 to 16 days.

Clinical Significance

CYP3A4 and CYP3A5 are liver enzymes that are responsible
for metabolizing approximately 50% of small molecule drugs,
and their induction often causes unwanted drug-drug
interactions and potential toxicities. Variants of
CYP3A4/3A5 are associated with significant phenotypic
variations that alter the rate of drug metabolism and may
cause increased or decreased drug efficacy or adverse drug
reactions.
Detecting genetic predisposition to altered CYP3A4/3A5
metabolism may help to avoid drug toxicity and can assist
the physician with optimizing therapeutic strageties for
maximum efficacy and minimal adverse effects.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.