First Next-Generation Sequencing Test for HIV Drug Resistance Could Help Combat AIDS Worldwide

PHILADELPHIA, Aug. 3, 2016 /PRNewswire-USNewswire/ -- Research announced today at the 68^th AACC Annual Scientific Meeting & Clinical Lab Expo demonstrates that a first-of-its-kind next-generation sequencing test can detect HIV drug resistance mutations that conventional tests fail to identify. This test could play a critical role in helping clinicians to optimize HIV treatment regimens, while also helping public health initiatives to minimize the development of global resistance to antiretroviral drugs.

The use of antiretroviral therapy to treat HIV has skyrocketed over the past decade as part of worldwide efforts to end AIDS as a public health threat. According to the World Health Organization, however, a concurrent increase in HIV drug resistance could undermine these efforts by compromising the ability of antiretroviral drugs to suppress HIV and stop its progression to AIDS. Testing for HIV drug resistance is key to ensuring that patients receive effective treatment and that public health initiatives have the information needed to manage antiretroviral drug resistance. However, almost all genetic sequencing tests for HIV drug resistance mutations are currently off the market. The only remaining commercial sequencing test dates from the early 2000s and is based on Sanger sequencing, an older technology that is expensive, can take 1–2 weeks to produce results, and has low sensitivity for drug resistance mutations that occur at a frequency below 15–20%.

A team of researchers led by Gerd Michel, PhD, Charlie Lee, PhD, and Elian Rakhmanaliev, PhD, from Vela Diagnostics in Singapore set out to fill this void by developing the first next-generation sequencing based test that can detect HIV drug resistance mutations. Known as the Sentosa SQ HIV-1 genotyping assay, it integrates automated sample processing and analysis with software for result reporting into one complete workflow. To evaluate the efficacy of the Sentosa, the researchers compared its performance with that of a Sanger sequencing-based test, the TruGene HIV-1 genotyping kit, which is no longer on the market. With both tests, the researchers tested 111 blood samples from HIV-1 patients for mutations in the virus's protease and reverse transcriptase genes, which are the two main genes that are typically analyzed in drug resistance testing.

The Sentosa demonstrated unprecedented sensitivity, detecting 100% of all drug resistance mutations in the protease gene compared to 90.45% detected by the TruGene, and identifying 98.16% of all drug resistance mutations in the reverse transcriptase gene compared to 74.48% identified by the TruGene. In total, the Sentosa detected 130 drug resistance mutations not found by the TruGene, while the TruGene only found 8 drug resistance mutations that the Sentosa missed. Another advantage of the Sentosa is that it produces results in 2.5 days, enabling patients to receive treatment much quicker than with Sanger sequencing testing. It also detects drug resistance mutations in the HIV integrase gene—a gene that is becoming increasingly important as a drug target in the U.S.

"To our knowledge, nobody else has developed an assay like this," said Michel. "Now we have the opportunity to do HIV drug resistance testing much faster, at a lower cost, and also to test for mutations that are not visible with Sanger sequencing. The impact of these mutations that have not been seen by Sanger is not known yet. But now we have the tools to detect them so that researchers can determine how relevant they are clinically and physicians can determine if there should be a change in treatment."

Vela Diagnostics plans to start making this test available to select collaborators this summer, and is aiming to get the CE mark for it in September.

In addition to this study, researchers will present the latest in HIV testing at the AACC Annual Scientific Meeting & Clinical Lab Expo, including:

• New findings that polyreactive antibodies found in HIV patients might play a previously unrecognized role in HIV-associated neurocognitive disorders (HAND) and HIV-associated dementia (HAD), and could serve as diagnostic biomarkers for these conditions. "Circulating plasmablasts of chronic HIV-infected individuals produce polyreactive antibodies crossreactive with NMDAR and contribute to HAND and HAD" (B-058)
• A new test that is designed to enable earlier diagnosis of HIV and that is as sensitive and specific as HIV tests that are currently on the market. "An evaluation of performance of the VITROS immunodiagnostic products HIV combo assay at two European trial sites" (B-049)
• Research validating two genetic tests that can identify subtypes of HIV-1 and HCV and help healthcare providers to tailor antiviral therapy for patients. "HIV-1 and HCV sequence-based genotyping methods validated against TRUGENE commercial kits" (B-055)

Session Information
AACC Annual Scientific Meeting registration is free for members of the media. Reporters can register online here: https://www.xpressreg.net/register/aacc0716/media/landing.asp

Scientific Poster B-063: Next Generation Sequencing-based HIV-1 Drug Resistance Monitoring System, and Scientific Posters B-049, B-055, and B058

Wednesday, August 3
9:30 a.m.–5 p.m. (presenting authors in attendance from 12:30–1:30 p.m.)
Terrace Ballroom
Pennsylvania Convention Center
Philadelphia

About the 68^th AACC Annual Scientific Meeting & Clinical Lab Expo
The AACC Annual Scientific Meeting offers 5 days packed with opportunities to learn about exciting science from July 31–August 4. Plenary sessions feature the latest research on the use of and testing for cannabis, combating premature death due to preventable causes such as tobacco and alcohol, the development of an "intelligent" surgical knife, programmable bio-nano-chips, and the epigenetic causes of disease.

At the AACC Clinical Lab Expo, more than 750 exhibitors will fill the show floor of Philadelphia's Pennsylvania Convention Center, with displays of the latest diagnostic technology, including but not limited to mobile health, molecular diagnostics, mass spectrometry, point-of-care, and automation.

About AACC
Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.

Christine DeLong
AACC
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Molly Polen
AACC
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