LamdaGen’s LAuRA digital platform is a field deployable rapid immuno-based testing system focused on high-sensitivity detection of infectious disease protein markers. The Point of Care (POC) platform is capable of performing tests for both the acute^* phase of the illness when patient has an active infection and is likely to be contagious and the convalescence^** phase that maps their immune response progression after the virus has been cleared from the patient bodies.

The company’s plasmonic-based sensing technology provides results in just minutes in nasal swabs, whole blood and other human samples, allowing decisions to be made at the point of use.

The LAuRA system can be integrated into small benchtop, small handheld and laboratory high-throughput systems as it is capable of performing multiplex or multi-panel immunoassay testing.

A high-sensitivity rapid antigen test capable of diagnosing the acute phase of COVID-19 (non-PCR-based) may be an ideal and more economical screen, as it will diagnose the infection early when a person is contagious, but may not be fully symptomatic. LamdaGen is developing this rapid screen for acute COVID-19 on the LAuRA digital platform.

^*The acute phase of infection includes the period when a patient is contagious but not necessarily symptomatic. Acute detection relates to direct testing for the virus itself (by PCR), or protein antigens shed by infected cells (by immunoassays). The acute phase last 0-14 days post infection and is followed by a ^**convalescent phase when antibodies (IgM and IgG) generated by the body’s immune response. Serological tests are used to detect these antibodies when they reach a level measurable qualitatively with existing POC devices.

MENLO PARK, CA, October 14, 2020—  LamdaGen Corporation, a developer of  plasmonic  biosensor systems for diagnostics, announced the European Patent Office (EPO) has granted its patent application entitled “Digital LSPR for Enhanced Assay Sensitivity” which enables highly sensitive and quantitative point of care (POC) diagnostic testing.

LamdaGen’s nano-based detection technology has been integrated into the company’s LAuRA Digital Diagnostic Platform. The rapid immuno-based POC platform couples the high sensitivity and quantitation of lab-based ELISA tests with the simplicity and speed of lateral flow assays (LFA), thus making it ideal for high sensitivity POC diagnostic application.

“This patent is central to our LAuRA digital platform andunderscores LamdaGen’s unique ability to harness the novel characteristics of advanced plasmonics to significantly amplify signal, which enables enhanced detection in rapid diagnostics,” commented Randolph Storer, CEO and Co-Founder of LamdaGen Corporation. “We are developing several infectious disease assays on the LAuRA platform that outperform commercial tests in side-by-side comparisons in terms of sensitivity and precision.”

LamdaGen’s Plasmonic Amplification Technology has been integrated into the LAuRA POC Diagnostic System. The simple and easy-to-use cartridge/reader system is aimed at improving health and wellness by making diagnostics more accessible and convenient at clinics, mobile testing sites, pharmacies and anywhere rapid on-site turnaround time is desired.

About LamdaGen Corporation

LamdaGen Corporation is a Silicon Valley developer of nano-based biosensors and powerful testing systems. The company’s mission is to develop and commercialize innovative technologies for disease detection wherever, and whenever, they are needed. We do this by focusing on providing high sensitivity global point of care diagnostics that are fast, simple, and available to improve human health and wellness. For additional information, please visit www.lamdagen.com or email 4info@lamdagen.com

Figure Caption

Top Tier: The viral load of SARS-CoV-2 in patients charted as determined in hospital settings across several regions of the world.[1-4] In three studies, the pool includes a limited number patients with mild to moderate symptoms in hospitals, while a fourth study includes a larger sample pool taken across a hospital network on the US East Coast.[4] The latter is considered more representative of the viremia in the general population since it likely includes asymptomatic patients.

Middle Tier: We report the results determined and published by the FDA of molecular tests from several manufacturers validated against an FDA reference panel.[5] Tests were performed in a blinded fashion and results reported to the FDA for confirmation of the assay outcomes.

Bottom Tier: As of October 2020, results using FDA blind reference panels have not been reported for rapid antigen tests, thus we chart the LOD as reported in the manufacturer’s package inserts.[6-9] Manufacturers used different inactivated virions samples for their analytical determination. Hence, the viral load of some samples (RNA equivalent/mL) cannot be determined based on the manufacturer’s disclosures and have thus been estimated.

Discussion

Interestingly, the general pattern for molecular tests shown above is that manufacturer reported LODs are 1-1.5 logs lower than the LODs determined using the blind FDA reference panels.

With this in mind, it is reasonable to anticipate there may be a similar pattern for rapid antigen tests between LODs determined by the manufacturer using their own reagents vs the reagents provided by a standard FDA reference panel. Hence, an LOD ~10⁶ RNA/mL remains a very desirable milestone for rapid antigen tests to achieve when validated using a standardized FDA reference panel.

What is truly needed, yet still unavailable, is a rapid antigen test with an LOD ~10⁵ RNA/mL or lower as a test with an LOD of 10⁴ RNA/mL would detect approximately 67% of true positive cases in the infectious stage, up from the ~31% with the current antigen tests on the market.[4]

The WHO recommendation for a rapid COVID-19 POC device and a broader Target Product Profile description can be found in Ref [10].

References

[1]        Y Pan et al., Viral load of SARS-CoV-2 in clinical samples, The Lancet Infection 20, (2020), 411-412

[2]        S. Iwasaeki et al., Comparison of SARS-CoV-2 detection in nasopharyngeal swab and saliva, Journal of Infection 81, (2020), e145-e147

[3]        K.K.K To et al., Temporal profiles of viral load in posterior oropharyngeal, saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study, Lancet Infect Dis (2020) 20: 565–74

[4]        R. Arnaout, R. A. Lee, G. Rye Lee, C. Callahan, C. F. Yen, K. P. Smith, R. Arora, J. E. Kirby, SARS-CoV-2 Testing: The Limit of Detection Matters, bioRxiv 2020.06.02.131144; doi: https://doi.org/10.1101/2020.06.02.131144

[5]        SARS-CoV-2 Reference Panel Comparative Data (accessed September 21, 2020): https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data

[6]        Veritor System For Rapid Detection of SARS-CoV-2 https://www.fda.gov/media/139755/download (accessed Jul 23, 2020)

[7]        Sofia SARS Antigen FIA https://www.fda.gov/media/137885/download (accessed Jul 23, 2020)

[8]        BinaxNow COVID-19 Ag card, IN195000 Rev1 2020/08 (accessed 2020-09-01)

[9]        B.D. Grant et al., SARS-CoV‑2 Coronavirus Nucleocapsid Antigen-Detecting Half-Strip Lateral Flow Assay Toward the Development of Point of Care Tests Using Commercially Available Reagents, Anal. Chem. 2020, 92, 11305−11309

[10]     World Health Organization, COVID-19 Target product profiles for priority diagnostics to support response to the COVID-19 pandemic v.0.1 https://www.who.int/publications/m/item/covid-19-target-product-profiles-for-priority-diagnostics-tosupport-response-to-the-covid-19-pandemic-v.0.1 (released July 31, 2020)