Industry Buzz: LabCorp Develops Test That Will Guide HIV Anti-Retroviral Drug Treatments

Thirty years ago, HIV infection led to AIDS and an inevitable death sentence. In the last 15 years, the virus has become a manageable chronic condition. Now one of the biggest challenges facing the health care system is fine-tuning the medications of those infected patients whose levels of HIV are so immunosuppressed as to be undetectable. HIV-infected patients often suffer side effects from their drug regimens such as anemia, nausea, and skin rashes. But adjusting their drugs without information on their actual viral load creates the risk of the HIV becoming resurgent and perhaps resistant to future treatments. There are about 1.3 million Americans who are infected with HIV. And while the infection rate has dropped by a third over the past decade, there are still 40,000 new cases of HIV being diagnosed in the United States every year, according to data from the Centers for Disease Control and Prevention. LabCorp has decided to address that dilemma by offering a new molecular test that provides clinicians with options about managing drugs even when they can’t detect HIV in their patients. The test was developed by the company’s Monogram Sciences affiliate. Known as the GenoSure Archive, the assay uses next-generation sequencing in combination with amplifying any cell-associated HIV pathogens. It can then be analyzed and matched for genetic mutations that signal potential drug resistance for all the major medicines used to keep HIV in check. Monogram has about 150,000 such profiles on file for matching purposes. “The launch of GenoSure Archive addresses an emerging need of today’s HIV patients and their care providers, who are increasingly faced with choices to maintain or adjust anti-retroviral drug regimens when the patient has low or undetectable plasma virus,” said Christos Petropoulous, Monogram’s vice president of research and development. “This test helps ensure that HIV/AIDS remains a chronic, manageable disease rather than a terminal illness.” LabCorp did not release pricing for the test or projected volumes. Takeaway: The melding of laboratory assays and pharmaceutical suitability takes a new turn with the development of the GenoSure Archive test.