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Molecular technology company Applied DNA Sciences (NASDAQ:APDN) — which has polymerase chain reaction (PCR)-based solutions among its many specialties — recently launched an analytical validation of its PCR test for monkeypox virus. The test is designed to identify the genetic signature of the monkeypox virus. This news comes as monkeypox cases are increasing, which in turn is driving demand for mitigation measures. As a result, APDN stock jumped 80% earlier this morning before settling in a 56% range by early afternoon.
Applied DNA Sciences developed the test under the New York State Department of Health’s (NYSDOH) Laboratory Developed Test designation. LDTs refer to a certain class of in vitro diagnostics (IVDs) and are important due to their regulatory profile. Generally, the Food and Drug Administration (FDA) does not mandate premarket review of LDTs, although it does make exceptions for high-risk iterations.
If Applied DNA determines that its monkeypox PCR test provides satisfactory results, it will submit a validation package to NYSDOH for approval. Dr. James A. Hayward, President and CEO of Applied DNA Sciences, said, “Based on our experience with the COVID-19 pandemic, we are acutely aware of the critical role that diagnostic tools based on on PCR can play to respond to and help control public health outbreaks.
“With a proven workflow and testing services born out of COVID-19, after test approval, [Applied DNA Sciences] is ready to apply its testing capability to serve the health of New Yorkers,” Dr. Hayward added.
The announcement of the tests and the subsequent increase in the stockpile of APDN comes against the backdrop of growing concern over the increase in monkeypox infections. Therefore, robust testing mechanisms can enable government agencies to better control and manage this latest outbreak.
APDN Stock and Sudden Relevance
As Americans gradually acclimated to the Covid-19 pandemic — accelerated in large part by the reduction of mitigation protocols — businesses related to the management of viral pathogens have generally suffered declines, sometimes severe. Even APDN stock was not immune, crashing 85% year-to-date (YTD) just before its resurgence.
The spike may have some sticking power, at least as long as monkeypox infections dominate the news cycle. For example, on Monday, California Governor Gavin Newsom declared a state of emergency to speed up efforts to combat the monkeypox outbreak, according to a PA report.
“We will continue to work with the federal government to get more vaccines, raise awareness about harm reduction, and support the LGBTQ community in the fight against stigma,” Newsom said in a statement announcing the emergency declaration.
On July 23 this year, the World Health Organization (WHO) declared monkeypox a global health emergency. Since then, New York and Illinois have also declared the monkey a public health emergency.
By CNBC“California, Illinois and New York – home to the three largest cities in the country – have reported 47% of all confirmed monkeypox infections in the United States. New York is the epicenter of the outbreak in the United States, with nearly 1,400 confirmed cases on Monday.” Thus, the need for management tools reinforces the bullish case for APDN stock.
why is it important
Monkeypox is not only an increased threat for officials to manage, but also imposes serious challenges on an individual level. For example, while monkeypox is not as contagious or deadly as the Covid-19 virus, the New York Times reported that people should still take precautions against infection.
In particular, some patients may experience excruciatingly painful symptoms, with one telling the NYT in an interview that misery felt like shards of glass against skin. With every incentive imaginable to ride out this crisis, APDN stocks are cynically enjoying their time in the spotlight.
As of the date of publication, Josh Enomoto had no position (directly or indirectly) in the securities mentioned in this article. The opinions expressed in this article are those of the author, subject to InvestorPlace.com Publication guidelines.