ultrasensitive detection of disease and biomarkers
Assays and Performance
Point-of-care immunoassays with unmatched sensitivity
Multiplexed Cardiac Panel
(Cardiac Troponin I, NT-proBNP, D-dimer)
Novilux SMC™ technology can multiplex assays both spatially and optically. Results from CLSI test protocols for the Novilux 3-Plex Cardiac Panel performed on the Phoenix PoC platform are shown below. Multiplexed panels are used to quickly rule-in or rule-out various conditions that often present with the same symptoms. For example, Acute Coronary Syndrome (ACS), Heart Failure (HF), and Pulmonary Embolism (PE) all share shortness-of-breath as a symptom. Cardiac Troponin I (cTnI) is critical to aid in the diagnosis of ACS (myocardial infarction in particular), NT-proBNP aids in the diagnosis HF and D-Dimer is used to help diagnose PE. Providing all three markers simultaneously can be of enormous benefit to Acute Care Physicians seeking to differentiate diagnosis of cardiac or pulmonary conditions with different etiologies when their presenting symptoms overlap.
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o cTnI results in 12 minutes o Superior sensitivity
o Tri-plex results in 13 minutes o Superior measurement range
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Cardiac Troponin I (cTnI)
Measured concentration (ng/L)
All samples
Lower 4 samples
Expected concentration (ng/L)
NT-proBNP
Measured concentration (ng/L)
Expected concentration (ng/L)
D-Dimer
Measured concentration (ng/L)
Expected concentration (ng/L)
Cardiac Troponin I (cTnI)
The graph to the left (upper plot) shows the results of a CLSI EP06 evaluation of Linearity and Measurement range evaluation for the cTnI portion of the cardiac panel. All points between 0 ng/L and 90,000 ng/L cTnI recover within +/-10% of expected values. The lower plot shows results from a CLSI EP17-A2 Detection Capability protocol. Corresponding LoBDQ results are shown in the table below.
NT-proBNP
Results for the NT-proBNP portion of the panel shown to left and below. Measurement range NT-proBNP: 0.4 ng/L - 26,000 ng/L
D-Dimer
Results for the D-Dimer portion of the panel shown to left and below. Measurement range D-Dimer: 11 ng/L - 31,000 ng/mL
SARS-CoV-2 Antigen (demonstration)
Novilux SMC™ technology is well suited to just about any immunoassay including the SARS-CoV-2 antigen. The SARS-CoV-2 assay is complementary to the cTnI assay owing to the established connection between the severity of COVID-19 infection and cardiomyocyte damage. Most SARS-CoV-2 antigen tests used today are lateral flow immunoassays with Emergency Use Authorization (EUA) by the US FDA. The SMC™ SARS-CoV-2 assay developed at Novilux for demonstration purposes is 100-fold more sensitive than these tests.
SARS-CoV-2 Antigen LoD
The graph on the right shows the relative sensitivity of a Novilux early prototype of the SARS-CoV-2 antigen SMC assay (in blue at 0.6 pg/ml) compared to many of the commercially available tests. These assays have a median LoD of 100pg/ml and with only one exception all have LoD's higher than 10 pg/mL. Other than Novilux, only the Quanterix Simoa has an LoD of less than 1 pg/ml. However, the Simoa assay cannot be done at Point-of-Care, and results take more than an hour after sending to a Centralized Lab running an LDT.
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Note: These results are for demonstration purposes. The results were generated using the Novilux RDP assay development platform. The assay has not been ported to the Phoenix Point-of-Care system.
Growing Ecosytem for Biomarker Development
One of Novilux out-licenses for the SMC™ technology is to MilliporeSigma (Merck KGaA) for the Research Use Only market. That license has enabled a large and growing installed base of SMCxPRO™ instruments, MilliporeSigma assay kits, and 1000's of researchers in the field developing new biomarkers based on SMC™ discoveries.
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As groundbreaking new clinical research validates important new biomarkers using SMC™ technology, Novilux is poised to collaborate and implement those biomarkers on its Phoenix Point-of-Care platform.
> 130 SMC™ Assays to Date
The graphic to the right shows a collection of 54 of the more than 130 ultrasensitive immunoassays developed to date on SMC™ platforms. The biomarkers enumerated here are important for monitoring a broad array of health conditions, many of which could be developed into diagnostic tests or panels.
An ecosystem for ultrasensitive assays is now taking shape where commercial Life Science discoveries can become validated diagnostic tests/panels via porting to Novilux ultra-high sensitivity, low-cost diagnostic platforms.
Infographic Footnote Key. Assays developed or sold by:
1. Novilux
2. Singulex
3. MilliporeSigma
4. External, SMCxPRO™ user developed
