NCSU Spinout Galaxy Diagnostics Targets Elusive Infections

Bartonella are small bacteria that can cause big health problems.

 Galaxy Diagnostics logoPervasive in the environment and difficult to detect, they can persist in the body for weeks or months unnoticed before causing serious chronic illnesses with symptoms including fatigue, joint pain, blurred vision, headaches, fever, skin rashes and more.  

A small Morrisville bioscience company, Galaxy Diagnostics, is confronting this mysterious health menace with a growing suite of commercial tests for accurately detecting Bartonella and other pathogens in people and animals.

“We’re on a social mission,” says Amanda Elam, Ph.D., Galaxy’s president. “We really want to transform clinical practice for the better and improve patient outcomes.”

A latecomer to the microbial party

Amanda Elam, Ph.D.
Amanda Elam, Ph.D.

The Bartonella genus has been identified and studied only since the 1990s, so the science underlying it is still emerging.

Bartonella appear to be prevalent in the environment, including households, where they have been confirmed in dust mites. First discovered in HIV patients, these bacteria are known to be life threatening to patients with compromised immune systems.

“Researchers are now asking if Bartonella infections are being missed in sick people with healthy immune systems,” Elam says.

In recent years some three dozen species of Bartonella have been identified. About half of them are known to cause a variety of infectious diseases in humans and animals, collectively known as Bartonellosis.

Because it is systemic, Bartonellosis can attack a variety of organs and tissues, including the blood, heart, liver, spleen, joints, and central nervous system. It has also been linked to three different cancers.

Bartonella are typically spread by fleas, lice, mites and other biting insects. Animals can also pass them to humans through scratches or bites (the aptly named cat scratch fever is one such infection).

About half of America’s cats are naturally infected with Bartonella, often by fleas, and tick transmission was recently confirmed by European scientists.

“About half of the ticks that carry Lyme disease in the United States also carry Bartonella, adding to the complexity of a potential Lyme disease diagnosis,” Elam says.

Dog and ownerPeople who spend time with animals, especially pet owners, veterinarians and vet technicians, have a higher risk of exposure to Bartonella. About one-third of vets are actively infected by the bacteria, and two-thirds have antibodies to them, Elam says.

Why the bacteria do or don’t cause a disease state is unclear. “We don’t really know why some people seem to be more susceptible than others,” she says.

“There is a practical complexity to these stealth infections that many people miss or resist,” she adds, likening Bartonellosis to infection by methicillin-resistant Staphylococcus aureus, or MRSA, a notoriously difficult-to-treat illness.

“The bacteria are there on our skin and get routinely flushed through our digestive systems,” she says. “Some of us get colonized in our sinuses and other places. But only a few of us actually develop disease. What other potential pathogens are all around us? How do we know when to look for them?”

Once properly diagnosed, Bartonellosis usually can be treated successfully with antibiotics.

Origins at NCSU’s vet school

Galaxy is based on the work of Edward Breitschwerdt, D.V.M., and Ricardo Maggi, Ph.D., of North Carolina State University’s College of Veterinary Medicine. The researchers developed an enhanced growth medium for culturing Bartonella, which are difficult to grow on a lab plate.

They found that when patient samples are kept in the growth medium for a week, the resulting bacterial load is increased to detectable levels. Then, using a proprietary version of the polymerase chain reaction (PCR), a common lab technique, they were able to amplify Bartonella DNA, yielding highly accurate tests with fewer false negatives.

Galaxy was established in 2008 to commercialize the technology. Breitschwerdt became the company’s chief scientific officer and Maggi its chief technical officer, though both men continue in their positions at NCSU -- Breitschwerdt as a professor of internal medicine and Maggi as an assistant research professor.

Galaxy says its Bartonella ePCR tests, using the technology it licensed exclusively from NCSU, are up to 10 times more accurate than conventional molecular diagnostics.

Bartonella bacteriaBetter tests are important because Bartonella infections often avoid detection or are misdiagnosed by physicians who aren’t familiar with the bacteria. Galaxy’s website contains case studies of patients who were wrongly diagnosed with lupus, multiple sclerosis, migraine headaches, fibromyalgia, asthma or other conditions before being accurately diagnosed with Bartonellosis by Galaxy’s tests. 

“Mainstream medicine doesn’t accept that these infections could be causing chronic symptoms,” Elam says.

Galaxy is working to change that misperception in the medical and veterinary communities.

“We’re pushing the medical education like crazy,” Elam says. “There is a whole new frontier of medicine around the role of infection in chronic disease.”

One obstacle to commercialization of Galaxy’s tests is that infectious disease researchers and clinicians are focused more on big epidemics or acute infections rather than chronic syndromes, Elam says. 

Another problem, she says, is that chronic infections are beyond the expertise of most primary care doctors and even many infectious disease specialists, who typically lack expertise in two relevant areas: host-response and immune function.

“So we’ve had the most success with rheumatologists and doctors in integrative medicine,” she says. “Those are the doctors who are really managing chronic disease in the market today.”

I’m a huge fan of the Biotech Center. For someone coming in cold into biotech, they really helped us get our feet under us and figure out where some resources were.

Amanda Elam, Ph.D.

Product menu expanding

Galaxy sells ePCR panels for detecting pathogens in blood, tissues and body fluids; DNA tests for identifying active infections; and antibody tests for determining prior infections. In addition to Bartonella, the products test for Anaplasma, Babesia/Theileria, Ehrlichia, Rickettsia and Borrelia burgdorferi, the bacterium that causes Lyme disease.

Galaxy has a strategic partnership with IDEXX Laboratories, a leader in animal health diagnostics. One of Galaxy’s animal tests is on IDEXX’s product menu.   

In addition to its revenues from product sales, Galaxy is backed by founder and angel investments and relies on state, federal and foundation grants for research and development.

The company received $115,000 in early-stage loans from the North Carolina Biotechnology Center (which the company is repaying, Elam proudly notes).

“I’m a huge fan of the Biotech Center,” she says. “For someone coming in cold into biotech, they really helped us get our feet under us and figure out where some resources were.”

Galaxy will eventually seek additional private investments and expand its staff of 10, but not until it reaches more milestones, Elam says. Those markers include broadening its menu of tests to include conventional testing for other bacteria and protozoa; developing more serological, DNA and molecular assays for tick-borne diseases; and shortening the three-week test turnaround time for Bartonella to a week or a few days.

Meantime, “we’re paying our bills,” she says.

Barry Teater, NCBiotech Writer
Wed, 01/10/2018 - 15:23