American Medical Laboratories

American Medical Laboratories

Contacts
To order tests or for more information:
Gary Milburn, Ph.D.
(800) 336-3718
www.aml.com

American Medical Laboratories is a commercial laboratory that currently provides a non-kit-based genotypic assay** and the ViroLogic phenotypic resistance test.

GENERAL INFORMATION

Assay Names	Genotype	TruGene™ HIV (Visible Genetics) [HIV-1 Genotyping, DNA Sequencing in AML test menu]
	Phenotype	PhenoSense™ HIV (ViroLogic)
Collaborators/Distributors		Visible Genetics, ViroLogic
Availability		Commercially available for research use only.
Regulatory Status		TruGene™ HIV is available for "Investigational Use Only" under an FDA-approved IDE in CLIA certified labs. AML is a CLIA certified laboratory. The phenotypic assay is a non-kit-based assay.** The FDA does not currently regulate non-kit-based tests through published regulations or site inspections.
Proficiency Testing Programs		CAP
Clinical Trials		No
Financial Assistance		No

**	Proprietary/Non-kit-based assays are sometimes referred to as "home brew" assays. See the background article regarding FDA regulation of kit- vs. non-kit-based assays.

ASSAY INFORMATION

Genotypic	Phenotypic	Codons Interrogated		Turnaround time		Sensitivity
TruGene™ HIV	PhenoSense™ HIV	RT	PI	TruGene™ HIV	PhenoSense™ HIV	TruGene™ HIV	PhenoSense™ HIV
Full sequence assay	Recombinant	40–247	1–99	7–14 days	19-xx days after setup	1,000 copies/mL	1000 copies/ml

METHODOLOGY

Genotype
TruGene™ HIV: See Visible Genetics

Phenotype
PhenoSense™ HIV: See ViroLogic

REPORT INFORMATION

Report	Drug Resistance Interpretation
Genotype	Yes	The report for the genotype assay is a modified form (content and format) of the standard Visible Genetics report and includes the raw clinically significant mutations as delineated in the Figure of the International AIDS Society (IAS)-USA’s published recommendations [1]. AML uses an internally developed algorithm, based on the consensus statement of the IAS-USA, May, 2000, to interpret sequences as resistant or susceptible to antiretroviral drugs on the basis of clinically significant mutations. Click here to see sample report (in PDF format).
Phenotype	Yes	PhenoSense™: See ViroLogic page.

1.	Hirsch MS, Brun-Vezinet F, D’Aquila RT, et al. Antiretroviral Drug Resistance Testing in Adult HIV-1 Infection: Recommendations of an International AIDS Society-USA Panel. JAMA. 2000 May 10;283(18):2417-26.

Return to Test Information Table - Genotypic

Return to Test Information Table - Phenotypic