ALS Diagnostics
Fast, Accurate, Results in just days
ACCELERATED ALS DIAGNOSTICS
This biomarker-based ALS test is the first rapid and reliable diagnostic tool for early intervention. Independently tested in over 800 patients and in active clinical use in the U.S. and Europe, this test can now radically accelerate the ALS diagnostic process through direct blood and CSF sampling.
As a laboratory developed test (LDT) under the Centers for Medicare and Medicaid Services’ (CMS) Clinical Laboratory Improvement Amendments (CLIA), our ALS Test is approved for clinical use and does not require FDA clearance or approval. All testing is conduct in a CLIA lab certified to perform high complexity clinical laboratory testing. This test is intended as an aid in diagnostic test for ALS and is not to be regarded as being investigational or for research.
- Proven – Clinically tested, accurate results.
- Fast – Test results delivered in days, dramatically shortening time to treatment.
- Advanced – The first biomarker-based test on the market; a breakthrough in ALS diagnostics.
DIAGNOSING ALS
Prior to this groundbreaking test, there was no single test to diagnose ALS. Instead, the diagnostic process has relied on ruling out other diseases that mimic ALS by using a combination of clinical exams and other tests. These may include the following procedures conducted over a year:
- Neurologic exam and nerve conduction study to determine nerve damage or muscular diseases.
- Electromyography (EMG) and nerve conduction velocity (NCV) tests to evaluate the electrical activity of your muscles.
- Spinal tap of the fluid surrounding the spinal cord to rule out other diseases.
- X-Rays, including magnetic resonance imaging (MRI) to spot tumors, herniated disks or other conditions.
- Blood and urine studies including thyroid and parathyroid hormone levels, urine heavy metal tests, and high-resolution serum protein electrophoresis to eliminate other possible causes of symptoms.
- Muscle and nerve biopsy to determine if there is a muscle disease rather than ALS.
The nVector ALS test supports comprehensive clinical diagnosis with reliable results available in a matter of days. This can provide patients with reliable results to begin earlier treatment for greater longevity and quality of life.
Disease Overview
Amyotrophic Lateral Sclerosis (aka ALS or Lou Gehrig’s disease) is a devastating disease that is nearly always fatal within 5 years of onset. The symptoms are similar to many other neuropathies beginning with weakening of the limbs, leading to partial or total paralysis and an increasing difficulty in breathing. Similarities in its symptomatic progression can make it difficult to differentiate ALS from several other disease mimics (motor neuropathy, progressive muscle atrophy, etc.) until it is too late for intervention to have any real effect. With an earlier diagnosis, and therefore earlier treatment, current clinical care may significantly increase the lifespan of patients. Additional drug therapies that are likely to be introduced to the market could be more rapidly initiated if patients are rapidly diagnosed. Not only might life expectancy increase, but patients would be given the chance for a higher quality of life for a longer duration due to more rapid inclusion into multi-disciplinary care treatment offered at specialized ALS clinics.
The incidence of ALS is approximately 6,000 cases per year in the US and nearly 120,000 globally*. Progression is rapid with ~50% of individuals dying within 18 months and over 75% dying within 5 years. ALS is responsible for nearly 100,000 deaths annually. ALS usually strikes those over 50 years of age and has a slightly higher prevalence in men than in women. People of all races, age groups, ethnicities and geographic locations are susceptible to the disease, though Caucasians are more likely to present with ALS than any other group.
