The Suit Magazine

It’s been estimated that at least 20% of the people in the US who are HIV positive are not aware that they are infected. Chembio is working to solve that problem. The company develops, manufactures, licenses and markets point-of-care diagnostic tests and technology for the detection of infectious diseases. With POC (Proof of Concept, i.e., verifiable) technology, people can take a diagnostic test and learn their HIV status in one hospital visit, and they can be immediately referred to treatment options.

In a timely development, President Obama has unveiled a new strategy in the fight against HIV and AIDS. The goal is to increase the proportion of people who are aware of their condition from 79% to 90% by 2015.

“You could almost say that President Obama and his Office of National AIDS Policy have adopted the strategy of companies [like Chembio] that are in the point-of-care rapid detection HIV business,” he said.

At the core of Chembio’s pipeline of new diagnostic tests is their patented Dual Path Platform technology, or DPP®, which allows for the development of multiplex tests for multiple diseases, or for different stages or aspects of a single disease. “DPP® has certain benefits and features that allow certain kinds of point-of-care tests to be developed that either cannot be, or cannot nearly as effectively be, developed using lateral flow and other platforms,” Seibert explained. “What exists today in the market, including the tests that we have in the US, are tests that are based on lateral flow technology. All the action occurs on one strip,” he said.

“When you’re dealing with a more viscous sample, like oral fluid, it’s better to separately provide for the reaction of the sample with the targeted analyte as compared with a lateral flow test where the colored indicator is combined with the sample before it even reaches the targeted analyte.

“With DPP®,” he offered, “you tend to have better sensitivity – meaning that you have a better chance to pick up weak positives, but you also have better specificity, meaning you don’t have nonspecific binding, which can show a false positive result.”

Two of Chembio’s DPP® tests for screening with oral fluid and for confirmation of HIV have already been approved in Brazil, and the oral fluid HIV screening test will be submitted to the FDA in 2011. Chembio’s lateral flow HIV tests are already FDA approved and sold under the brand of Alere Inc., a leading POC diagnostics company. Alere distributes the product to hospitals, physicians, clinics, and public health organizations, both nationally and internationally.

The applications of DPP® are wide-ranging. Chembio’s HIV tests, which screen for antibodies in whole blood or in oral fluid, are less labor intensive than other testing options. They require no special equipment, are easy to use and read, and need only a minimal sample volume.
“Our lateral flow HIV tests are basically the same technology, for all intents and purposes, as the home pregnancy test. It’s that simple; DPP® has improved performance over lateral flow through provision of an intermediate incubation step,” Siebert said.

Today, only one oral HIV test, Oraquick, has been approved in the US.“The CDC [Center for Disease Control] conducted a study in Mozambique earlier this year. They compared our product to the Oraquick product as well as to two of the leading blood tests used throughout the world,” he said. “Our test performed the best of the four. [It] performed with specificity of 100% and the sensitivity of 99.8%.”

Chembio is also conducting clinical trials for a point-of caretest for syphilis in the US. Currently, syphilis tests are administered, sent out, screened and, if initially positive, tested again to confirm the results. That process can take days or weeks. The amount of time necessary to confirm a diagnosis can deter people from receiving treatment for syphilis, though antibiotics can effectively cure the infection.

“With our DPP® Syphilis Screen and Confirm,” Siebert affirmed, “you can screen and confirm a case of syphilis with one single POC testing device in 15 minutes.”

In an exciting development, the company has entered into a million dollar development contract with the CDC to create an immune status influenza test, which enables public health officials to locate areas of exposure in the US and the different strains active in those areas.

“It’s not a test to see if somebody has the virus or is sick. It’s simply to see what strains they’ve been exposed to, to help understand what strains are traveling to what regions of the country,” Siebert explained.

There is also work in its early development stage for an oral fluid test for Hepatitis C. Chembio’s DPP® technology even offers potential veterinary applications, including production and domestic animals. Other potential applications include food safety, environmental screening, bioterrorism, forensics, agriculture and industry. As the possibilities for its products grow, so does Chembio’s success.
Areas of the world in which Chembio has worked include the US, Africa, Mexico and Brazil. A 2004 collaboration with Brazil led to four more royalty and licensing agreements entered into in 2008, under which technology developed by Chembio will become available for use in Brazil. Brazil will then have the ability to manufacture its own products to combat HIV and other infectious diseases. As mentioned above, two of these products are now approved in Brazil. Additional agreements are under discussion.

One of the biggest challenges facing the U.S.is making the HIV test available over-the-counter. “Because of this continuing segment of our population that is not aware of its status, many key opinion leaders in public health, such as Dr. Bernard Branson at the CDC,[aresupporting attempts to have these testsbecome available for over-the-counter sale to consumers, provided [that] appropriate regulatory approvals and conditions are taken into account,” Siebert said. “That’s something we’re working on.”

The company originally started with 20 workers and has grown to nearly 120 employees. Since the FDA began to approve Chembio’s products, business has swelled. “We feel we have a strong market position now. We’re close to 18-20% market share,” said Siebert.

With revenues growing at 30% per year, DPP® technology is driving the company’s growth, opening more opportunities for new collaborations. “One of the challenges that we have now is that people don’t know us because our products are not being marketed in the U.S. under our brand – yet,” Siebert emphasized.

The newly approved diagnostic testing products will enter the market by the end of 2010 with the trademarked Chembio brand and the DPP® mark. The company’s participation in the World AIDS Conference in Vienna, Austria, this past July and in a March for AIDS Awareness in New York City, along with other forms of outreach, is helping the brand become a household name.
 

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