CLN Article

Regulatory Roundup

DiaDexus Receives Clearance for Test That Predicts Risk of Heart Disease

The Food and Drug Administration (FDA) has cleared a new screening test from the company diaDexus that predicts a patient’s risk of future coronary heart disease events, such as heart attacks. FDA cleared the test for use in all adults with no history of heart disease, but studies submitted by diaDexus and reviewed by FDA show that the test is better at discerning this risk in women, and particularly in black women.

Known as the PLAC Test for Lp-PLA2, this new assay measures the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2) in a patient’s blood. Lp-PLA2 is a biological marker for vascular inflammation, a condition associated with the buildup of plaque in arteries that supply blood to the heart. Patients with test results that show Lp-PLA2 activity greater than the level of 225 nmol/min/mL are at increased risk for a coronary heart disease event, while patients with test results below this level are at decreased risk.

The FDA requested data analyses of additional subgroups, including black women, which showed that black women experienced a higher jump in the rate of CHD events compared to other participants when Lp-PLA2 levels were higher than 225 nmol/min/mL. As a result, the test’s labeling contains separate performance data for black women, black men, white women, and white men.

FDA Approves First Test to Confirm Human T-cell Lymphotropic Virus-I/II Antibodies

The Food and Drug Administration (FDA) approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II). This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test. The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay test intended to confirm infection with HTLV and to differentiate between HTLV-I and HTLV-II. The MP Diagnostics HTLV Blot 2.4 provides blood establishments with additional information to convey to the donor, confirming HTLV infection and determining which virus type is causing the infection.

FDA Grants CLIA Waiver for Alere Determine HIV-1/2 Ag/Ab Combo Test

The Food and Drug Admin­is­tration (FDA) has granted CLIA waiver for the Alere Determine HIV-1/2 Ag/Ab Combo test. Until now, the test has been available for sale in the United States to health facilities and laboratories licensed to conduct tests of moderate complexity. With this approval, the test will now be available for use in physician offices, clinics, and other public health settings.

FDA approved the Determine HIV-1/2 Ag/Ab Combo in August 2013 as the first fourth-generation, rapid point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen. Due to its capability to detect p24 antigen, which can appear in only days after infection and before the HIV antibody is detectable, fourth-generation tests may detect HIV infection earlier in the course of the disease.

First CLIA Waiver for Syphilis Test

The U.S. Food and Drug Admin­istration (FDA) recently granted the first-ever CLIA waiver for a rapid screening test for syphilis, the Syphilis Health Check test. The test is a qualitative rapid membrane immu­nochromatographic assay for the detection of Treponema pallidum antibodies in human whole blood, serum, or plasma.

The test is performed by obtaining a sample of whole blood from a finger stick. Results are available in as little as 12 minutes. All positive tests should be followed up with further syphilis serological laboratory testing and clinical evaluation before final diagnosis, according to FDA.

FDA first cleared the Syphilis Health Check test in 2011 and categorized it under CLIA as moderate- and high-complexity. The test is manufactured by VEDA LAB of Alencon, France for Diagnostics Direct. It is also distributed by Trinity Biotech USA.