Fact Diagnostic

Through the discovery of a unique “pain protein” that can identify the source of musculoskeletal pain, Cytonics has developed FACT, a diagnostic molecular biomarker used to identify symptomatic intervertebral discs or painful joint abnormalities. FACT is used to measure the presence of the Fibronectin-Aggrecan Complex (FAC) and other related biomarkers in a fluid specimen taken from patients with musculoskeletal pain. FAC is a unique molecular complex that has been reported in peer reviewed publications to be associated with painful inflammation.

What is FACT? (Fibronectin-Aggrecan Complex Test)

FACT is a novel antibody test that was developed as an optimized assay to detect the Fibronectin-Aggrecan Complex. The test is a heterogeneous sandwich ELISA utilizing anti-fibronectin immobilized on solid support and anti-aggrecan-G3 as a detection antibody. FACT measures the presence of the Fibronectin-Aggrecan Complex and other cytokines in a fluid specimen taken from patients that experience musculoskeletal pain. FACT can be used by physicians for testing synovial fluid from any joint or from intradiscal fluid obtained by Molecular Discography. Your FACT score can help your physician determine what is going on below the surface-beyond those signs and symptoms you and your doctor can see and feel.

Physicians commonly use MRI imaging to identify orthopedic abnormalities. However, MRI has limitations. Many patients have “normal” looking anatomy following a traumatic injury even though degenerative enzymes may be at work causing pain and slowly destroying their joint. Additionally, patients often have non-painful abnormalities that are indistinguishable from painful conditions. The limitations of MRI often lead to misdiagnosis and ineffective treatment, leaving patients to continue to suffer in pain following treatment, despite the best intentions of their physicians.

Research has shown that an inflammatory cascade of proteins causes back and joint pain. The FACT diagnostic assay detects a unique biomarker (Fibronectin-Aggrecan Complex) in this cascade allowing physicians to pinpoint and treat the source of pain.

Like most other laboratory tests, FACT must be ordered by your physician.

Why Should your patient Get FACT?

FACT assesses a cartilage breakdown product present in painful disc disease and painful joint abnormalities. FACT can be used for Molecular Discography and for Joint Diagnostic. FAC is a unique molecular complex that is specific for painful inflammation of the spine and cartilage. The results can assist physicians in determining their next course of treatment. FACT can be used to predict functional outcomes from spinal intervention and can also assist physicians in differentiating between painful joint abnormalities in which inflammatory and degenerative molecules in an inta-articular joint can be sampled in the physician’s office and assessed in the laboratory.

In conjunction with other testing, FACT helps rule in the necessity for treatment. FACT used alone does not rule out the need for treatment. FACT can help your physician determine the source of pain and determine the best course of treatment.

FACT for Molecular Discography

In spine surgery, the identification of which intervertebral disc is symptomatic is challenging. Landmark studies have demonstrated that MRI alone cannot reliably distinguish a disc causing symptoms from one that is not, even when correlated with patient history and physical examination. FACT can be used for identification of a symptomatic intervertebral disc requiring treatment.

Studies have demonstrated a high rate of degenerative changes to the lumbar spine identified by MRI of the lumbar spine in asymptomatic volunteers. Identifying which disc causes symptoms in any one patient is highly subjective, requiring careful correlation with patient history and physical examination. This can create reimbursement challenges for indicated procedures when different interpretations of the findings conflict.

Fibronectin-Aggrecan Complex (FAC) is the single best molecular biomarker to predict functional outcome from spinal intervention. FAC is a unique molecular complex that is specific for painful inflammation of the spine and cartilage. FACT is used to identify symptomatic intervertebral discs by the process of Molecular Discography.

FACT has been developed for Molecular Discography in which inflammatory and degenerative molecules in the disc space can be sampled and assessed in the laboratory. Scientific evidence is mounting that FACT for Molecular Discography can offer higher efficacy and more improved benefit/risk ratios than provocative discography. The technique of Molecular Discography has been developed through meticulous research and clinical trials. Each phase of the sample collection, chemical treatment, shipping and storage is essential in order to detect molecular biomarkers successfully.

The use of traditional provocative discography can have potential benefits, but also has received variable reports regarding efficacy, and risks vs. benefits ratio. In traditional provocative discography, a needle is inserted into one disc at a time in an attempt to produce concordant pain that reproduces a patient’s daily back pain. Despite its potential benefits and numerous practitioners, provocative discography has received variable reports regarding efficacy, and risk vs. benefits concern. This uncertain climate is creating increasingly difficult reimbursement challenges for provocative discography alone. The development of FACT for Molecular Discography enables more robust reimbursement for evidence-based medicine.

FACT For Joint Diagnostic?

In joint surgery, the differentiation between a cartilaginous abnormality identified by MRI which is symptomatic and which is degenerative and asymptomatic is challenging. Studies have shown that MRI alone cannot reliably distinguish a joint abnormality causing symptoms from one that is not, even when correlated with patient history and physical examination.

Despite its potential benefits and numerous practitioners, arthroscopy can have variable outcomes and in some cases the risks exceed the benefit for the patient. The uncertain climate is creating reimbursement challenges for arthroscopy. There is no diagnostic method that has a high efficacy and risk/benefit ratio for patients with joint pain. This was the inspiration for the development of FACT for joint diagnostics.

What Does the FAC Score Mean?

The background of the assay for the FAC is 0.05+/- 0.01 in units of optical density (OD) at 450nm wavelength. Accordingly, any value that is in the range of 0.00 to 0.06 is considered negative for the presence of the complex. Any value higher than 0.1 is considered positive for FAC for identifying painful disc syndromes. Values that are between 0.06 and 0.1 are considered weak positive. A weak positive could be due to sample dilution during the lavage process.

absorption-range

The FACT score provides valuable information to doctors and complements their clinical assessment. It can assist in discussions about the next course of treatment and management of pain.

Your doctor will receive a test report that will provide a number that indicates the presence of Fibronectin-Aggrecan present in the synovial fluid. A sample of a Test Report is shown below:

Sample Report For Molecular Discography

Analyte Test L1/L2 L2/L3 L3/L4 L4/L5 L5/S1 Positive Range
Fibronectin Aggrecan Complex (FAC) N/A 0.24 0.53 1.21 0.05 OD > 0.10

Sample Report For Joint Diagnostic

Analyte Test Site 1 Site 2 Positive Range
Fibronectin Aggrecan Complex (FAC) 0.34 2.2 OD > 0.10