AMPEL BioSolutions Seeks $12.5M to Market its Personalized Blood Test for Lupus

AMPEL BioSolutions is seeking $12.5 million in funding to market LuGene, a personalized blood test that uses genetic information from a patient to predict treatment response and lupus flares.

The company has initiated a Series A round of financing, which refers to the first significant step of venture capital financing.

LuGene initially targeted lupus, but the test may be utilized for other autoimmune or inflammatory diseases. AMPEL’s goal is to have LuGene available for regular use by physicians in the next few years. According to the company, LuGene could change the way chronic diseases are treated.

The lab test is ready for commercialization to support treatment decisions and help improve health care based on a patient’s genes. LuGene analyzes genetic results using machine learning to predict when flares are going to occur.

“Predicting lupus disease flares, allowing initiation or modification of disease-modifying therapies, should have an important impact on patient health,” Mary K. Crow, MD, physician-in-chief at the Hospital for Special Surgery, and chief of rheumatology at Weill Cornell Medical Center, said in a press release.

“LuGene seems to be an important step in that direction. Application of knowledge of molecular mechanisms to aid in patient management is the future of lupus care and will benefit patients and improve outcomes,” added Crow.

Studies with AMPEL’s gene-based approach showed that machine learning can help predict disease status in people with lupus.

“Unpredictable flares can be a daily battle for many patients with lupus and other autoimmune conditions,” said Deidre Baptista and Kirsten Maeda, the “GEE Twins for Lupus” and board members at the Lupus Foundation of Northern California. “From personal experience, we know flares come and go without warning and make it challenging for patients. AMPEL’s promising breakthrough of their LuGene diagnostic is the news patients have desperately been waiting to hear.”

“We applaud AMPEL BioSolutions’s goal to help identify patients’ disease activity in real time,” they added.

LuGene will also help companies pick the right patients for their clinical trials. Enrolling participants with the greatest likelihood of responding to a treatment candidate is important, as tests in people less likely to show benefits could end the clinical development of a medicine that may still be effective in a specific group of patients.

By helping to recruit suitable participants, AMPEL’s approach may maximize success of a clinical trial, the company said.

“Lupus care will greatly benefit from more precise evaluation of patients. LuGene seems to be an important step in that direction,” said Daniel J. Wallace, MD, a professor of medicine at the David Geffen School of Medicine at UCLA. “Patients would greatly benefit from a better way to relate their symptoms to immune abnormalities.”