Independent Forensics (Hillside, Illinois), which says it is the "leading independent forensics laboratory" in the U.S., has developed what it says is the world's first test to determine genetic resistance to HIV.
The test is designed to determine if a person is a fast, neutral or slow progressor to AIDS after HIV infection. The test would help physicians determine very early on how aggressive a therapy treatment a patient should receive with the hope that, in the case of fast progressors, in particular, they could slow the time to disease appearance.
"We believe the CCR5 Haplotype Test is one of the most important things an individual with HIV can do to help in their treatment," said Jack Keehma, CEO of Independent Forensics. "It is part of our philosophy to 'Know Thyself,' knowing your own genetic makeup will help everyone make informed and healthy life decisions."
The test, which measures the genetics of CCR5 receptors on T-cells, uses a buccal swab collection procedure which can be done at home, but that needs a physician to evaluate the results. Test results are available in three weeks.
Keehma said that because it is only a genetic test, not a diagnostic test i.e., it is not utilized for diagnosing HIV infection it does not require FDA approval.
CCR5 is the primary HIV receptor in T-cells, and Caucasian individuals contain varying amounts of the receptors on their T-cells based on their genetic makeup. The fewer available CCR5 receptors an individual has the more likely they will have a slow progression to AIDS when infected with HIV.
"Years of studies by internationally recognized HIV experts have proven the importance of CCR5 receptors in determining HIV progression levels," said Karl Reich, chief scientific officer. Reich previously worked for Abbott Laboratories (Abbott Park, Illinois)
DNA extraction is accomplished via a single-tube extraction method followed by CCR5 specific amplification, and analysis is completed using a Beckman Coulter CEQ8000 Genetic Analyzer to detect single nucleotide polymorphisms (SNPs) and deletions, the company said.
But Keehma said Independent Forensics, which has about 15 employees, including five PhDs and two forensic scientists, is the first to have one available on the market.
He said that he was aware that at least one big-name pharma company is developing therapies for HIV that would seem to require a genetic test to know a person's makeup and likehood of responding to that drug. So, there may be other tests to determine genetic resistance to HIV in the future.
With many drug therapies, even with something like cholesterol, there is sometimes a one-size-fits-all approach to prescribing medication, Keehma said. Unfortunately, that can mean that patients who need a more aggressive therapeutic approach don't get it, or those who don't require an aggressive therapy may have problems with drug toxicity if they are overmedicated.
Independent Forensics will be marketing to physicians, as well as directly to consumers. Already, Keehma said, there is quite a bit of discussion on the Internet and blogs regarding the company's test.
If a consumer calls or e-mails Independent Forensics, the company will send that consumer a swab. The patient then swabs the inside of his or her mouth and follows the instructions for sending the swab sample to the company. Keehma noted that the information belongs to the patient.
One big hurdle to overcome may the fact that physicians are the recipients of intense sales and marketing efforts from a variety of companies that it may be difficult getting their message through to them, Keehma said.
One way to circumvent that is to partner with a larger company with an existing sales force, such as a pharma company. "That's one of our goals," he said.