Novel Tests Emerging For Overlooked Conditions

Undeniably, much of the emerging test focus is on cancer and infectious diseases. DTET wants to showcase other novel tests entering the marketplace. What follows is a sampling of novel tests entering the commercial marketplace.

Optimizing Treatment Selection for Wound Infections
CogenDx (Millennium Health; San Diego, Calif.) hopes that its DxWound test will enable patients to receive faster, appropriate treatment for infected wounds. The test launched in October.

DxWound uses polymerase chain reaction technology to identify microbes responsible for wound infections. It assesses the microbes most commonly associated with skin and soft tissue infections, including aerobic and anaerobic bacteria, fungi, plus it is able to assess antibiotic resistance.

Samples are taken directly from a swab of the wound and do not require culture. A special transport buffer preserves the wound microbiome during transit. Test results are usually returned one business day following specimen receipt in the laboratory.

According to CognDx’s IDWeek presentation (San Diego, Calif.; Oct. 4-8), results from the tests enable clinicians to select targeted antibiotics with greater likelihood for efficacy. This, the company says, can translate to improved health outcomes for patients and reduced costs of care, particularly when treated within 48 hours of suspected infection. CogenDx currently has a study underway to evaluate the economic impacts of inappropriate antibiotic therapy in inpatients being treated for skin and soft tissue infections.

Noninvasive Monitoring for Crohn’s Disease
During the 2017 American College of Gastroenterology conference (Orlando, Fla.; Oct. 13-18) Prometheus Laboratories Inc. (Nestlé Health Science; San Diego, Calif.) launched a new serum test that measures and monitors mucosal healing status in Crohn’s disease patients. The company presented clinical validation and test performance data for the Monitr test, which is the first test to provide a noninvasive tool for patient management.

“We really need an objective way to view snapshots of the mucosa without frequent scoping,” said Marla Dubinsky, M.D., chief of pediatric gastroenterology and hepatology at the Icahn School of Medicine, Mount Sinai (New York). “The more noninvasive biomarkers we can assay to objectively evaluate the mucosa, the better off patients will be.”

Crohn’s disease is notoriously difficult to monitor because the only available diagnostic tools—colonoscopy and endoscopy—are invasive and expensive. Additionally, experts say, symptoms do not necessarily correlate to the amount of inflammation present.

Prometheus says Monitr gives the physician “flexibility” for assessing mucosal disease, as the test can be used as an adjunct to endoscopy or by itself, between endoscopies, allowing for more frequent, noninvasive monitoring. The test relies upon 13 biomarkers and delivers results through a Mucosal Healing Index on a 100-point scale, with 0 to 40 indicating a patient is in remission or has mild endoscopic disease, whereas 50 to 100 indicates patients have endoscopically active disease. The company said the Monitr test demonstrated high accuracy and concordance rates with endoscopically visualized mucosal disease activity in adult Crohn’s disease patients, regardless of the anatomical disease location or selected treatment regimens. In a trial of 412 longitudinal specimens from 118 patients with Chron’s disease collected at the time of or close to endoscopy, the test accuracy was 95 percent, 90 percent, and 87 percent for ileal, ileocolonic, and colonic disease, respectively.

New Hope for a Blood Test to Diagnose MS
Diagnosing multiple sclerosis (MS) is not easy. Current diagnostic standards require neurologists to look for disease progression in successive MRI scans in combination with other invasive tests such as lumbar punctures. There is renewed hope that a simple blood test will be able to offer more rapid diagnosis, and possibly offer insight about disease progression.

IQuity (Nashville, Tenn.) launched its IsolateMS test early this summer. The company says that it can offer a quick “rule in” or “rule out” at first sign of disease symptoms, with test results in a week. Timely diagnosis and treatment, they say, can slow disease progression.

The company’s analytics process is called IQIsolate and uses machine learning to develop algorithms that analyze RNA gene expression in whole blood. Using RNA analysis, IsolateMS is able to distinguish between healthy people and patients with MS with 90 percent accuracy. The test costs approximately $1,250, which the company says is a worthy investment as it can better identify patients with MS who would benefit from costly drugs. Experts say that up to one-third of MS cases may be misdiagnosed.

Researchers from Australia recently published a study in Nature Scientific Reports demonstrating that nine micro-RNA molecules are capable of not only distinguishing MS patients (n=25) from healthy controls (n=11), but they can also discriminate between patients with relapsing-remitting MS and progressive MS.

“This blood test may allow people with MS to begin treatment earlier, and identify the most appropriate treatment for their condition,” said Matthew Miles, CEO MS Research Australia, which funded the research, in a statement. “This, in turn may lead to fewer relapses and a slower loss of brain volume, resulting in slowing or potentially halting progression of the disease for the person living with MS.”

The researchers used next generation sequencing and integrative bioinformatics to identify the micro-RNA profile found in exosomes traveling in the blood. The exosomes are released by brain cells, but cross the blood-brain barrier and can be captured through a normal blood draw.

Takeaway: While not capturing the headlines in the same way that emerging cancer tests are, these novel tests have the potential to impact clinical care decisions and health outcomes, as well as possibly being cost effective.