NyRoC – Know Your Risk of Clotting

/NyRoC – Know Your Risk of Clotting
NyRoC – Know Your Risk of Clotting 2018-09-20T15:06:55+00:00

CLOTTING RISK – Major Health Care Problem
Leading Cause of Death

Introducing NyRoC – Screening Test for Thrombosis (Clotting of Blood)

Aptamer Diagnostic, Inc developed Aptamer for the D-Dimer series of Fibrin Degradation Products, a CRITICAL BLOOD CLOT LEVEL INDEX. D-Dimer levels are critical when Deep Venous Thrombosis (DVT), Pulmonary Embolism (PE), or Disseminated Intravascular Coagulation (DIC) are suspected.

Test Principle

NyRoC Point of Care Test for D-Dimer uses the aptamer ADI1701 that is specific for D-dimer conjugated to nanoparticles. The aptamer nanoparticle migrates vertically on the membranes and gets captured using a recognition molecule that is immobilized on the membrane and binds to ADI1701 when the D-dimer levels are below a certain threshold. The capture of the complex at the test zone develops a blue color on the membrane when the d-dimer levels are less than 500 ng/ml. When the D-dimer levels are above 500 ng/ml the aptamer nanoparticle conjugate binds to D-dimer in patients’ sample and forms a complex that migrates vertically on the membranes displacing the binding to the recognition molecule, making the blue color disappear.

D-Dimer tests can eliminate or reduce the need for invasive and unnecessary imaging procedures, treatment and hospital stays when blood clotting conditions are ruled out. In other words, a negative D-Dimer test in combination with a low pre-test probability
of venous thromboembolism can be used to exclude the diagnosis and thus safely reduce the number of unnecessary referrals for testing and imaging. This test can be used in clinical laboratories, physician’s office, hospitals, as well as at home.

Expected Values and Test Limitations

Clinical Diagnosis should not be based on the results of the NYROC Point of Care Test for D-dimer. This test is used as a screening tool to eliminate the risk of deep vein thrombosis (DVT), pulmonary embolism (PE) and disseminated intravascular coagulation (DIC). The full clinical context of the patient should be taken into consideration when making a diagnostic decision.
A positive (appearence of only control spot) result indicates that the patient should consult with their healthcare professional for additional testing and imaging. A positive result with the test is obtained when the D-dimer levels in the blood are above 500 ng/ml, a cut off value thought to be clinically relevant by physicians.
Elevated levels of D-dimer have also been reported in cases of pro-coagulant state such as surgery, trauma, sickle cell disease, liver disease, severe infection, sepsis, inflammation, malignancy and, in the elderly. Increased levels of D-dimer are also seen during normal pregnancy, but very high levels are associated with complications.
Negative D-dimer levels may occur with DVT due to factors such as patients with high pretest probability, age, location of the clot, and heparin therapy. A positive result (appearance of only control spot) indicating active fibrinolysis may be obtained with NYROC when D-dimer levels are greater than or equal to the cut off approximately 500ng/ml as measured by an ELISA method.

Summary

During blood coagulation, activated thrombin converts fibrinogen into fibrin, the result of which is fibrin monomers that polymerase to form a soluble gel of non-cross-linked fibrin. Activated Factor XIII then converts the soluble fibrin gel to cross-linked fibrin.
The formation of the fibrin clot triggers the production of plasmin, a major clot-lysing enzyme that circulates as the inactive proenzyme, plasminogen. Plasminogen binds to both fibrinogen and fibrin, thereby being incorporated into a clot as it is formed.
The activated form of tissue Plasminogen Activator (tPA) cleaves plasminogen to plasmin which then digests the fibrin; the result is a series of soluble Fibrin Degradation Products (FDP) to which neither plasmin nor plasminogen can bind.

D-Dimer is a unique FDP produced from cross-linked sections of fibrin, a reliable marker that has been correlated with a number of conditions. High level of D-dimer is commonly used as a biomarker for deep venous thrombosis (DVT), pulmonary embolism (PE) and disseminated intravascular coagulation (DIC).

Aptamers

Aptamers are small DNA, RNA, or peptide fragments that are engineered to bind to specific targets – small molecules, large biomolecules, and even cells. Aptamers are often referred to as “synthetic” antibodies. Since their advent in 1990, Aptamers have been developed for use in diagnostics.

Aptamers for D-Dimer

Aptamers specific to the D-Dimer series of FDPs have been published in a patent (US 20140296500 A1, Pub. date: Oct 2, 2014), but the development of the testing platform and validation of the diagnostic protocol is done first time by Aptamer Diagnostic.

Advantages

The inherent high affinity, specificity, biochemical stability, low to absent immunogenicity, fast production, and relatively low cost of production makes Aptamers very desirable as substitutes for antibodies in diagnostics and future therapeutic applications.

Description of the Invention:

Replacement for Ab-based Immunoassay

Agglutination:

Just 2 Drops of Whole Blood
Pre-op Diagnostics (Point-of-care) Clinics
Drug stores

For personal use as
recommended by health care provider

Turbidimetry:

(Automated, High Throughput; Ab substitute)
Reference Laboratories
Clinical Diagnostics

Competitive Advantages:

Replacement for Ab-based Immunoassay

Low Capital Investment:

No Instruments
No Laboratory
No Technologists
Room Temperature Storage of Reagent
No Transportation to the Laboratory

Dignostic Speed:

5 Minutes in Office vs. Hours, if Not Overnight

Covenience:

Anyone can follow the test kit instructions

Cost Effective:

Saving of 90% of the current D-Dimer testing cost

Patent Status:

Patent filed and available for the sequence and the developed device

Development Status:

Development Stage completed. Ready for distribution.

Aptamer Life Science

8501 Wade Blvd. Bldg. 9, Frisco, TX 75034
Phone: 972-668-6005
Fax: 972-668-6720
Email: contact@aptamerlifescience.com