LamdaGen Corporation, a privately-owned company focused on the development and commercialization of plasmonic biosensor systems for Point of Care (POC) diagnostics, announced today the Indian Patent Office has granted and recorded patent 360405 titled ENZYMATIC ASSAY FOR LSPR which enables high sensitivity and quantitative POC diagnostic testing. This patent is an important element of the Company’s expanding global patent portfolio and patent applications that protect LamdaGen’s Plasmonic Amplification Technology (PAT) immunoassay-based diagnostic technologies.

“We are pleased with the Indian grant which completes this global patent family. These patents broadly protect LamdaGen’s ability to perform ELISAs on any active Localized Surface Plasmon Resonance (LSPR) surface,” commented Randolph Storer, CEO and co-founder of LamdaGen Corporation. “This assay technique enables a powerful double-amplified plasmonic signal that yields remarkably deep sensitivities for use in high-sensitivity diagnostic detection.”

The Company’s digital PAT system is central to its LAuRA Diagnostic Platform. This rapid immuno-based POC system couples the high sensitivity and quantitation of lab-based ELISA tests with the simplicity and speed of lateral flow assays (LFA). The easy to use and economical system is ideal for greatly expanding access to high sensitivity and mobile diagnostic testing across multiple health sectors and geographies.

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 accessible to improve human health and wellness. For additional information, please visit www.LamdaGen.com or email 4info@LamdaGen.com

MENLO PARK, CA, January 18, 2021— LamdaGen Corporation, a privately-owned company focused on the development and commercialization of plasmonic biosensor systems for Point of Care (POC) diagnostics, announced today the United States Patent and Trademark Office has given Official Notice of Allowance to its patent application entitled DIGITAL LSPR FOR ENHANCED ASSAY SENSITIVITY which enables high sensitivity and quantitative POC diagnostic testing. This patent is part of a portfolio of patents and  patent applications that protect LamdaGen’s Plasmonic Amplification Technology (PAT) rapid immunoassay-based diagnostic technology.

 “We are pleased to strengthen our intellectual property protection with the addition of this patent in the US which further covers our core LAuRA diagnostic platform,” commented Randolph Storer, CEO and co-founder of LamdaGen Corporation. “We have consistently sought to protect and expand our plasmonics-based patent portfolio in the U.S. and worldwide.”

The Company’s digital PAT system is central to its LAuRA Diagnostic Platform. This rapid immuno-based POC system couples the high sensitivity and quantitation of lab-based ELISA tests with the simplicity and speed of lateral flow assays (LFA). The easy to use and economical system is ideal for greatly expanding access to high sensitivity and mobile diagnostic testing across multiple health sectors and geographies.

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

MENLO PARK, CA, January 8, 2021—  LamdaGen Corporation, a developer of  plasmonic  biosensor systems for diagnostics, announced the Japanese Patent Office has given Official Notice of Allowance to its patent application entitled MOBILE/WEARABLE DEVICES INCORPORATING LSPR SENSORS which enables high sensitivity and quantitative rapid point of care (POC) diagnostic testing.

LamdaGen’s Plasmonic Amplification Technology (PAT) 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 and mobile POC diagnostic applications.

“This patent is central to the Company’s digital PAT system underscoring 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. “Coupling our PAT system with mobile devices such as smartphones offers an ideal solution for deploying high sensitivity and rapid disease testing even in the most remote parts of the world.”

LamdaGen has developed a benchtop LAuRA POC diagnostic system, powered by PAT technology, which is advancing into commercialization for infectious disease testing. The PAT technology is also being integrated into easy to use mobile and field solutions aimed at improving convenience and expanding access to high sensitivity and rapid diagnostic testing for both developed and developing countries.  

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

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-CoV2 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)

Menlo Park, CA and San Diego, CA – LamdaGen Corporation and Arisan Therapeutics announced today they have been awarded a $2 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health (NIH) to develop a high-sensitivity point-of-care (POC) dual diagnostic to detect both acute dengue and Zika viral infections in a single rapid test on LamdaGen’s LAuRA digital diagnostic platform.

The LAuRA platform enables robust diagnostic testing that is simple, compact and cost effective with no moving parts. LAuRA technology can be integrated into designs ranging from miniaturized handhelds to small desktops to lab-based throughput systems, each providing powerful on the spot performance of high sensitivity, rapid and quantitative diagnostic assays.

Global incidence of dengue has grown dramatically in recent decades with about half of the world’s population now at risk. In fact, incidence of both dengue and Zika are escalating and prone to unpredictable outbreaks due to climate shifts and proliferation of carriers such as mosquitoes and ticks. Currently an estimated 390 million dengue infections occur around the world annually. Of these, approximately 500,000 cases develop into life-threatening dengue hemorrhagic fever (DHF) or dengue shock syndrome (DSS), severe forms of the disease which result in over 25,000 deaths globally each year.

“Early diagnosis of patients with dengue in particular is critical for timely clinical intervention and disease control,” commented Randolph Storer, CEO of LamdaGen. “Dengue and Zika are closely related, and currently there is no FDA-approved multiplex POC test that can differentiate between the two during the acute phases of infection. Our collaborators at Arisan have identified highly specific antibodies for each test which we are integrating into the development on the LAuRA platform.”

In addition to enabling differentiation between the two viruses, this highly sensitive and quantitative POC assay will have the potential of acting as a prognostic for identifying patients at risk of developing severe forms of dengue including dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS) based on concentration of viral antigen found in blood. Early and rapid identification of these at-risk patients may help reduce mortality and morbidity by enabling immediate monitoring and medical care.

Speaking of the importance of this NIH grant, Ken McCormack, President of Arisan added, “We are very appreciative of NIH’s support and very excited to move forward in our collaboration with LamdaGen to develop these potentially life-saving solutions.”

Research supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R44AI127055. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Technology Platform for Quantitative, Ultra-Sensitive and Rapid Diagnostics

MENLO PARK, CA, October 26, 2016 – LamdaGen Corporation, a leading developer of diagnostic biosensors, introduced the LAuRA digital platform to meet the requirements of decentralized, patient-centric mobile testing while delivering precision, speed and high sensitivity. LAuRA enables quantitative rapid testing at the point of need and is compatible with any biomarker, including low-abundance ones.

LAuRA enables precision diagnostics outside the walls of the hospital. The system’s micron-sized sensors are easily integrated into small diagnostic Point of Care (POC) and miniaturized handheld systems for rapid quantitative detection and diagnosis. The mobile detection systems are ideal for applications ranging from Human and Companion Animal, Animal Food Stock, Food Safety and consumer-oriented Digital Health.

LAuRA is particularly well suited for remote patient monitoring and settings such as emergency rooms, intensive care units and first responder units, as well as for on-site testing in clinics, urgent care facilities, physician offices or pharmacies.

LAuRA enabled product examples include:

  • Miniaturized handheld single or multiplexed POC devices
  • Small form factor desktop units for more involved clinical needs
  • Powerful quantitative card-sized rapid disposable tests
  • Various forms of diagnostic wearable devices

LAuRA’s plug and play nano-based biosensors enable the detection of complex biological or environmental samples into precise digital data, resulting in new levels of rapid and quantitative diagnostic capabilities.

For information and details contact L.AuRA@LamdaGen.com

Patent for Ultra-Sensitive and Rapid Assay System

MENLO PARK, CA, June 22, 2015 — LamdaGen Corporation, a leading developer of diagnostic biosensors, today announced it has received notification from the European Patent Office (EPO) of its intention to grant the patent application entitled “Enzymatic Assays for LSPR” which enables highly sensitive and rapid diagnostic assays.

LamdaGen’s patented nano-based LSPR (Localized Surface Plasmon Resonance) sensors are ideally suited for In-Vitro Diagnostic (IVD) and Point of Care Testing (POCT) systems, facilitating precise quantitation into the low femtomolar range, significantly lower than that of current conventional ELISA assays. This new patent broadly covers nano-plasmonic LSPR surfaces and particles used as solid supports for high-speed and quantitative plasmonic immunoassays.

This EPO allowance, coupled with other patents and patents in process, serves to expand the application and protection of the Company’s core LSPR technologies. “The granting of this patent underscores LamdaGen’s novel ability to harness the significant potential of advanced plasmonics to greatly enhance detection sensitivity, precision and speed over current commercial diagnostics,” commented Randy Storer, CEO and Founder of LamdaGen Corporation. “We are working with a number of global companies to integrate our powerful LSPR sensing technology into existing diagnostic systems, various mobile devices and other advanced IVD systems companies have in development.”

About LamdaGen Corporation

LamdaGen is a private nano-based technology platform company who is the first to produce commercial LSPR products. The products include highly sensitive nano-biosensors for In Vitro Diagnostics, including Central Laboratory based and Point of Care testing for human, veterinary and farm animal health. The Company’s nanotechnology platforms are also purposed for additional scientific applications and products including drug discovery and development and life science research. For more information, visit www.lamdagen.com or email info@lamdagen.com

Integrated Nanoplasmonic Sensing for Cellular Functional Immunoanalysis Using Human Blood

ACS Nano, February 19, 2014

Bo-Ram Oh, University of Michigan, et al.

Abstract: 

Localized surface plasmon resonance (LSPR) nanoplasmonic effects allow for label-free, real-time detection of biomolecule binding events on a nanostructured metallic surface with simple optics and sensing tunability. Despite numerous reports on LSPR bionanosensing in the past, no study thus far has applied the technique for a cytokine secretion assay using clinically relevant immune cells from human blood. Cytokine secretion assays, a technique to quantify intercellular-signaling proteins secreted by blood immune cells, allow determination of the functional response of the donor’s immune cells, thus providing valuable information about the immune status of the donor. However, implementation of LSPR bionanosensing in cellular functional immunoanalysis based on a cytokine secretion assay poses major challenges primarily owing to its limited sensitivity and a lack of sufficient sample handling capability. In this paper, we have developed a label-free LSPR biosensing technique to detect cell-secreted tumor necrosis factor (TNF)-α cytokines in clinical blood samples. Our approach integrates LSPR bionanosensors in an optofluidic platform that permits trapping and stimulation of target immune cells in a microfluidic chamber with optical access for subsequent cytokine detection. The on-chip spatial confinement of the cells is the key to rapidly increasing a cytokine concentration high enough for detection by the LSPR setup, thereby allowing the assay time and sample volume to be significantly reduced. We have successfully applied this approach first to THP-1 cells and then later to CD45 cells isolated directly from human blood. Our LSPR optofluidics device allows for detection of TNF-α secreted from cells as few as 1000, which translates into a nearly 100 times decrease in sample volume than conventional cytokine secretion assay techniques require. We achieved cellular functional immunoanalysis with a minimal blood sample volume (3 μL) and a total assay time 3 times shorter than that of the conventional enzyme-linked immunosorbent assay (ELISA).