Siemens Healthineers Joins with Quanterix to Develop Blood Tests for NfL Levels

Siemens Healthineers has signed a license and supply agreement with Quanterix that helps it in developing blood tests for neurofilament light chain (NfL) to aid in early disease detection, evidence of progression, and measuring treatment response in people with neurological disorders such as multiple sclerosis (MS).

Siemens Healthineers will gain access to Quanterix’s antibodies necessary for detecting NfL in biological samples, these companies announced in a press release.

Quanterix owns the antibodies as part of its recent acquisition of UmanDiagnostics, which developed key reagents for quantifying NfL in samples of blood and cerebrospinal fluid (CSF; the fluid inside and around the brain and spinal cord).

NfL is of increasing interest to researchers and the medical community as a biomarker for neurodegenerative diseases including MS, Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS).

Since the discovery of elevated NfL levels in MS patients, it has emerged as a promising new biomarker for the disease. Researchers believe it will have an important role in clinical practice for evaluating disease activity and progression.

When nerve fibers (axons) in the central nervous system (brain and spinal cord) are damaged, neurofilament proteins including NfL are released into the CSF, providing a sign of axonal damage and neuronal death.

The biomarker can reflect ongoing neuronal damage, which can be of great value to stage MS disease, help predict patients’ prognosis, and track treatment effectiveness.

Siemens Healthineers’ focus is to develop a blood-based test for NfL.

While testing the neurofilament in CSF samples collected by spinal tap provides direct access to the central nervous system, testing NfL in blood samples is less invasive. Moreover, as neurofilaments are neuron-specific proteins, finding these proteins in the blood could reflect leakage in the blood-brain barrier (BBB) — a cell barrier that controls the movement of substances between the blood and brain, and whose impairment can be one of the earliest alterations in MS.

“We believe NfL is an important blood-based neurological biomarker that, in the future, could positively impact patient outcomes by potentially aiding in earlier diagnoses, intervention, and management of patients with a broad array of neurological conditions, such as multiple sclerosis (MS), Alzheimer’s disease, Parkinson’s disease, and ALS,” David Stein, head of Global Strategy at Siemens Healthineers, said in the release.

“A blood-based NfL assay is highly compatible with our global diagnostic solutions, and we are pleased to be working with Quanterix for access to its unique set of Uman Nf-L antibodies for the development of high performance clinical Nf-L assays,” Stein added.

As part of the agreement, Quanterix will supply its “best-in-class” Simoa NfL assays, while developing new digital biomarkers to advance the field of research in diagnostics for neurological disorders.

Data recently presented at the 2019 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) provided evidence that a Siemens Healthineers’ assay employing Quanterix antibodies performed similarly to the gold standard NfL Simoa assay.

“We are pleased to have the opportunity to work with as formidable a partner as Siemens Healthineers to accelerate the availability of an NfL test for patients around the world,” said Kevin Hrusovsky, Quanterix’s CEO, president, and chairman.

“This agreement demonstrates a clear path for our research customers working with Simoa technology to take groundbreaking advances like the NfL test to the clinic. We believe this will give our researchers even more confidence working with Simoa in research,” Hrusovsky added.