The ID Pipeline: FDA Activity From the Week of May 19, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of May 19, 2019.

FDA Grants Marketing Authorization of Diagnostic Test for Zika Antibodies

On Thursday, May 23, 2019, the FDA authorized marketing of the ZIKV Detect 2.0 IgM Capture ELISA, the first diagnostic test to detect Zika virus immunoglobulin antibodies in human blood.

This test is the first Zika diagnostic test that the FDA has permitted to be marketed in the United States, as previous tests have only been authorized for emergency use. With this marketing authorization, the FDA has revoked the Emergency Use Authorization for this product, which was previously granted in 2016.

The FDA’s decision was based upon data from a clinical study of 807 test samples and a multitude of analytical studies, which demonstrated that the test was safe and effective at identifying immunoglobulin antibodies against Zika virus in the blood.

The test, which is marketed by InBios International, Inc., has been designed to identify antibodies produced by the immune system when testing for Zika virus infection in the blood. The immunoglobulin antibodies indicate an early immune response.

Results of the test are intended to be used alongside clinical observations, epidemiological information, patient history, and other laboratory evidence to make decisions on patient management.

The full article is available here.

FDA Clears Extragenital Tests for Chlamydia and Gonorrhea

On Thursday, May 23, 2019, the FDA approved marketing for 2 tests that can detect bacteria that cause chlamydia and gonorrhea through diagnostic testing of extragenital specimen. The 2 tests, Aptima Combo 2 Assay and Xpert CT/NG are the first devices cleared for testing for these sexually transmitted infections (STIs) via the throat and rectum.

The US Centers for Disease Control and Prevention (CDC) estimates that the rate of STIs are on the rise with an estimated 1.7 million cases of chlamydia and more than 500,000 cases of gonorrhea documented in 2017 in the United States. Both STIs can be contracted through vaginal, anal, or oral intercourse. The infections are typically easily treated, but, if left untreated, can result in serious complications including infertility.

Both the Aptima Combo 2 Assay and Xpert CT/NG were previously cleared by the FDA for testing urine, vaginal, and endocervical samples.

The tests were reviewed through the premarket notification 510(k) pathway, which is a submission made to the FDA demonstrating that the device is safe and effective and “substantially equivalent” to a legally marketed device.

The full article is available here.

Marketing of First Diagnostic Test to Detect Prosthetic Joint Infections Permitted by FDA

On Thursday, May 23, 2019, the FDA approved marketing for the first diagnostic tool to aid in detecting periprosthetic joint infection (infection around a joint replacement) in the synovial fluid of patients being evaluated for revision surgery.

The Synovasure Lateral Flow Test Kit works by detecting human alpha defensins proteins in the the synovial fluid of patients with a total joint replacement within 10 minutes. The kit is able to detect whether an infection is present, but is not intended to identify infection types.

“Prior to today’s authorization, there were no FDA-authorized diagnostic tests specifically designed to help health care professionals determine whether the inflammation around a prosthetic joint was due to an infection or another cause,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a press release. “With this test, health care professionals now have an additional option available to aid their clinical assessment as to whether the patient has an infection and requires revision surgery. Whereas before surgeons may have opted for surgery when the presence of an infection was unclear, with this test, they have more information and could potentially reduce patient risk by avoiding unnecessary revision operations for replacement joints.”

The full press release is available here.