ultrasensitive detection of disease and biomarkers
Assays and Performance
Point-of-care immunoassays with unmatched sensitivity and speed
Novilux products are not approved for diagnostic use
Cardiac Troponin I Flexibility
(Turnaround Time | Sensitivity | Multiplexing)
Cardiac Troponin I (cTnI) is critical to aid in the diagnosis of Acute Coronary Syndrome; myocardial infarction in particular. In the acute setting where cTnI is utilized, medical practitioners often cite that "time is muscle" when emphasizing the need for timely intervention to minimize potential ischemic damage to the heart.
​The Phoenix PoC system is designed to deliver high sensitivity cTnI results with an 8.7 minute time-to-result (TTR) at the point-of-care from whole blood. Ultra-high sensitivity cTnI performance can be produced with an 11.8 minute TTR. Ultra-high sensitivity may be important for rule - out of MI at the point-of-care and may ultimately enable cardiac health monitoring based on routine cardiac troponin measurement.
​The ability the of the Phoenix to multiplex biomarkers enables cTnI to be combined with NT-proBNP, D-dimer and other markers for simultaneous analysis in a patient sample delivering additional information to the clinician to better understand the patient's condition. ​
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o hs-cTnI results in 8 min 42 s​ o ultra-hs-cTnI results in 11 minutes 49 s o multiplexing for cardiac panels
Fast Turnaround hs-cTnI (8.7 min)
Measured concentration (ng/L)
Expected concentration (ng/L)
All samples
Ultra-High Sensitivity cTnI (11.8 min)
Measured concentration (ng/L)
Lowest 4 samples
All samples
Expected concentration (ng/L)
Fast Turnaround hs-cTnI LoBDQ
Results summarized in the table below are from a single-plex test protocol where assay parameters were adjusted to optimize time-to-result over sensitivity. As shown even with an 8.7 minute TTR the Phoenix platform generates sensitivity results superior to large diagnostic instruments in the reference lab.
Ultra-High Sensitivity cTnI LoBDQ
The graphs to the left and table below show the results from running Cardiac Troponin I in a multi-plexed panel with NT-proBNP and D-dimer in the Ultra-High sensitivity mode where Phoenix assay processing parameters were adjusted for Sensitivity vs. TTR. These results were produced in 11.8 minutes and demonstrate sensitivity at Point-of-Care that is 13X better than large diagnostics instruments in the reference lab (LoBDQ comparison based internal testing and review of available hs-cTnI 510K filings for the leading eight reference lab instruments.)
LoBDQ results are shown in the table below:
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. The Novilux 3-Plex Cardiac Panel can provide results for all three markers in less than 13 minutes from whole blood specimens.
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Ultra-High Sensitivity cTnI
Measured concentration (ng/L)
All samples
Lowest 4 samples
Expected concentration (ng/L)
NT-proBNP
Measured concentration (ng/L)
Expected concentration (ng/L)
D-Dimer
Measured concentration (ng/ml)
Expected concentration (ng/ml)
Ultra-High Sensitivity cTnI
The graph to the left (upper plot) shows results of a CLSI EP06: Linearity and Measurement Range with test concentrations between 0 ng/L - 168,000 ng/L. All 14 concentrations recover within +/-10% of expected values. The lower plot shows results from a CLSI EP17-A2: Detection Capability with 4 concentrations shown between 0 ng/L and 1.68 ng/L. The corresponding LoBDQ results are shown in the table below.
o Replicates of 60 ea. LoB and LoD, 40 ea. for LoQ 10% and 20%.
o Blanks made from cTnI depleted plasma
o Sample at 0.24 ng/L is more than 4.5 SDEV above blank
NT-proBNP
Results for NT-proBNP Measurement Range with test concentrations between 0 ng/L - 36,000 ng/L shown in plot to the left. LoBDQ results shown in table below.
D-Dimer
Results for D-Dimer Measurement Range with test concentrations between 0 ng/L - 13,000 ng/mL shown in plot to the left. LoBDQ results shown in table below.
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™ and FemtoQuest™ 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™ Immunoassays 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 (SMCxPRO™ & FemtoQuest™)
4. External, SMCxPRO™ user developed
