AMPEL BioSolutions has officially announced the launch of LuGENE® blood test, which will rethink the way doctors manage the autoimmune disease, Lupus. Marking a big breakthrough for personalized precision medicine, the stated blood test comes decked up with an ability to predict flares associated with Lupus before they happen. Apart from that, it also provides specific information about a patient’s disease abnormalities that might have a hand in causing some of their notable symptoms. The idea behind doing so is to help physicians make evidence-based decisions regarding therapy, including whether a patient is stable on their current therapeutic regimen or requires adjustment. Talk about the Lupus disease for a second, though, it is basically a condition where patients experience inflammation and pain from their immune system attacking their own organs and tissues with the same vigor as fighting off an infection. As a result, it causes symptoms like extreme fatigue and “brain fog” that impact daily activities, including work and family life. To give you a better idea of its wider impact, according to one survey done by Lupus Foundation of America, nearly fifty-five percent of patients with Lupus reported a complete or partial loss of their income because complications from their disease render them unable to work full time. Not just that, one in every three patients was found to be temporarily disabled by the disease, whereas one in four has already been receiving disability payments. Making the whole situation even worse is how, thus far, doctors have struggled with inadequate metrics to assess whether their patient is stable or not.
“As a clinician, I am tired of wasting my patients’ valuable time and money by trying different therapies for their Lupus using the ‘trial and error’ methodology, which is our only option now,” said Dr. Don Thomas, Rheumatologist at Arthritis & Pain Associates of Prince George’s County in Maryland, author of the Lupus Encyclopedia & Former Chair Advisory council Lupus Foundation of America DC/MD/VA, “This approach to taking care of Lupus patients ends up causing so much misery as they deal with life-altering symptoms and complications when therapies do not work or cause them side effects.”
But how will AMPEL’s latest brainchild solve such a conundrum? Well, you see, more than 95 percent Lupus patients have experienced a flare of symptoms in the last year. Hence, in response, the new LuGENE® test identifies real-time abnormalities leading to inflammation and immune system dysfunction, abnormalities that are especially targetable by medication. This it does by segregating Lupus patients into eight different groups. Next up, it pinpoints the patient subgroup(s) that express the target of one or both of the FDA-approved drugs for Lupus, Benlysta and Anifrolumab, so to provide decision support for physicians and potentially shorten the time to effective therapy. At present, the stated test is available through AMPEL’s ReLATE study, which is going on at Cedars-Sinai in LA, and Arthritis & Osteoporosis Consultants of the Carolinas (AOCC) in Charlotte NC. For the near future, the plan is to expand to more sites across the US, including Arizona Arthritis & Rheumatology, Feinstein at Northwell Health, Mayo Clinic, Providence Healthcare, Rush in Chicago, Hospital for Special Surgery, Cleveland Clinic, University of Maryland, Yale, MetroHealth at Case Western Reserve, U Mass, Duke, and others.
“The LuGENE® blood test is incredibly exciting as it represents an important advance towards achieving personalized medicine for Lupus patients by using novel technology of explainable predictive AI and analytics that group all known gene expression by drug target,” said Dr. Cindy Aranow, Feinstein Institute at Northwell Health.