COVID-19 Research at the CDI

CDI accomplishments during the pandemic

The CDI was established to bring innovations in science to the clinic in real time. In keeping with the notion that clinical need drives our science, CDI scientists contributed major innovations for the clinic involving diagnostics, therapy, and surveillance to meet the unprecedented pressures brought by the COVID-19 pandemic.

  1. PCR Diagnostics – As COVID-19 began to rage in China, it was recognized that diagnostics would be the key to early patient management. Dr. Yanan Zhao and Dr. David Perlin started development of a diagnostic platform in early January 2020. When the COVID-19 cases started appearing in our hospitals, clinical laboratories were still dependent on the health department and CDC to accurately diagnose patients. The problem was that it took 8-10 days for a confirmation, which was unmanageable as more and more severely ill patients were presenting to the emergency rooms. Validating the test was initially logistically difficult. But with help from Senator Robert Menendez, we obtained a sample of the virus to validate our testing platform and we received FDA EUA on March 12, 2020, for clinical use with our clinical partner Hackensack University Medical Center. Our highly sensitive PCR test gave results within 2 hours enabling our hospitals to better tirage and help severely ill patients. Hackensack Meridian Health was one of the first healthcare systems with an in-house PCR detection platform to test patients at the onset of the pandemic in the USA. The CDI test has been used to diagnose tens of thousands of patients in New Jersey, and it has been used more broadly following licensing to T2 diagnostics to diagnose millions of patients.
  2. Therapy – During the early phase of the pandemic, there were no vaccines or therapies available. Severely ill patients queued at emergency departments and rapidly progressed to critical care and many required mechanical ventilation to support breathing. Unfortunately, many patients ultimately succumbed. In partnership with Transplant Physician Dr. Michele Donato at the John Theurer Cancer Center, we adopted a 100-year-old approach called convalescent plasma therapy. This approach transfers the blood of patients recovered from infection and who have mounted a strong antibody response to severely ill patients to help them fight off the virus. To accomplish this, we established a test to detect antibody levels and validated that the neutralizing antibodies could protect healthy tissue from the live virus in our Biosafetly Level 3 labs. We screened more than 1000 recovered patients and found a subset of patients who mounted supra high levels (titers) of antibodies. Dr. Donato then used those ‘high titer’ donors to treat her patients. This approach using high-titer serum was nearly 90% effective in preventing patients from progressing to more severe disease, especially when used early in the disease course.
  3. Surveillance – As virus variants of concern started emerging in Fall of 2020, all laboratories were dependent on sequencing the viral RNA, which is both time consuming and expensive. We realized the need to develop a diagnostic test that was high-throughput and rapid to detect variants of concern. Dr. Yanan Zhao again set out to develop such a test. The developed platform allowed us to detect numerous variants of concern including alpha, delta, omicron, and omicron sub-variants. The information from this test provided our clinicians with a handle on the types of viruses patients would be presenting to emergency departments to help them make better informed treatment choices with antibody cocktails, a go-to first line of therapy. By partnering with Quest Diagnostics, the New Jersey Department of Health (NJDOH), and New York Genome Center (NYGC), we have provided comprehensive information about viruses of concern and trends across our State that involves evaluation of nearly twenty thousand viruses.

    Tracking COVID-19 Next Chapter

  4. Pharma – It is noteworthy that during this period, CDI used its experience in working with neutralizing antibody titers and virus under biological safety level 3 (BSL-3) conditions to support Pfizer with Phase 1, 2 and 3 evaluations of patient sera from initials trials of their COVID-19 vaccine, which was performed in our BSL-3 labs. CDI trained more than 50 Pfizer scientists to work under containment. CDI also worked with Merck to help discover next generation antiviral drugs targeting SARS-CoV-2 and other coronaviruses, which formed the basis for the new $108 million grant for the Metropolitan Antiviral Drug Accelerator (MAVDA). Finally, CDI has also worked with Regeneron to examine host genetic factors in patients who developed severe COVID-19 in the absence of any known risk factors.
  5. Biorepository (Bio-R) – It was recognized at the earliest stage of the COVID-19 epidemic that organized collection and processing of biological specimens from hospitalized patients linked to clinical data would be essential to understand this disease. The Bio-R, led by David Chow, M.D. and Ya’el Kramer, diligently collected thousands of specimens from patients after obtaining informed consent for those specimens to be used for research purposes. Basic categories of patient specimens based on clinical disease states were collected and include patients who were hospitalized, critically-ill and in the ICU with or without mechanical ventilation. Specimen types include: nasal and oropharyngeal swabs, extracted nucleic acid, blood, serum, respiratory fluids, stool and indwelling devices. The BioR has collected and cataloged >73,000 specimens.

Next Generation Antiviral Drugs for Outpatient Use

On May 16, 2022, the CDI received approval from the NIH/NIAID for a $108 million award to create the Metropolitan Antiviral Drug Accelerator (MAVDA), as one of nine national antiviral centers of excellence funded by the National Institutes of Health (NIH)/ National Institute of Allergy and Infectious Diseases (NIAID) under the Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern. AViDD research centers target SARS-CoV-2 and other viruses with pandemic potential such as paramyxoviruses, bunyavirales, togaviruses, filoviruses, picornaviruses, and flaviviruses.

The MAVDA program, led by Dr. David Perlin (Center for Discovery and Innovation) and Nobel Laureate Dr. Charles Rice (Rockefeller University), was established to engage world-class virologists and academic drug discovery experts, as well as industry professionals centered largely in New Jersey and New York City to develop small molecule drugs suitable for outpatient use against SARS-CoV-2, and other coronaviruses and viruses of pandemic potential.

MAVDA currently supports Five Projects from academia and industry representing a diverse portfolio of targets and approaches. An integrated network of Pharma-style science cores with highly experienced Core directors ensures that compound identification and optimization proceed efficiently with clear ‘Go/No Go’ criteria to support compound maturation. The overall MAVDA performance is guided by a world-class Scientific Advisory Board consisting of industry and academic experts who have developed more than a dozen antivirals and related anti-infectives. Current MAVDA institutional members include the Center for Discovery and Innovation at Hackensack Meridian Health, Rockefeller University, Columbia University, Memorial Sloan Kettering, Rutgers University, the Tri-Institutional Therapeutics Discovery Institute, Merck, and Aligos Therapeutics, Inc.

CDI COVID-19 Related Publications

2022

Zhang Q, Bastard P; COVID Human Genetic Effort, Cobat A, Casanova JL. Human genetic and immunological determinants of critical COVID-19 pneumonia. Nature. 2022 Mar;603(7902):587-598. doi: 10.1038/s41586-022-04447-0. Epub 2022 Jan 28.PMID: 35090163

Brodin P, Casari G, Townsend L, O’Farrelly C, Tancevski I, Löffler-Ragg J, Mogensen TH, Casanova JL; COVID Human Genetic Effort. Studying severe long COVID to understand post-infectious disorders beyond COVID-19. Nat Med. 2022 May;28(5):879-882. doi: 10.1038/s41591-022-01766-7.PMID: 35383311

Zhang Q, Matuozzo D, Le Pen J, Lee D, Moens L, Asano T, Bohlen J, Liu Z, Moncada-Velez M, Kendir-Demirkol Y, Jing H, Bizien L, Marchal A, Abolhassani H, Delafontaine S, Bucciol G; COVID Human Genetic Effort, Bayhan GI, Keles S, Kiykim A, Hancerli S, Haerynck F, Florkin B, Hatipoglu N, Ozcelik T, Morelle G, Zatz M, Ng LFP, Lye DC, Young BE, Leo YS, Dalgard CL, Lifton RP, Renia L, Meyts I, Jouanguy E, Hammarström L, Pan-Hammarström Q, Boisson B, Bastard P, Su HC, Boisson-Dupuis S, Abel L, Rice CM, Zhang SY, Cobat A, Casanova JL. Recessive inborn errors of type I IFN immunity in children with COVID-19 pneumonia. J Exp Med. 2022 Aug 1;219(8):e20220131. doi: 10.1084/jem.20220131. Epub 2022 Jun 16.PMID: 35708626

Perlin DS, Neil GA, Anderson C, Zafir-Lavie I, Raines S, Ware CF, Wilkins HJ. Randomized, double-blind, controlled trial of human anti-LIGHT monoclonal antibody in COVID-19 acute respiratory distress syndrome. J Clin Invest. 2022 Feb 1;132(3):e153173. doi: 10.1172/JCI153173.PMID: 34871182

Bolze A, Mogensen TH, Zhang SY, Abel L, Andreakos E, Arkin LM, Borghesi A, Brodin P, Hagin D, Novelli G, Okada S, Peter J, Renia L, Severe K, Tiberghien P, Vinh DC; COVID human genetic effort, Cirulli ET, Casanova JL, Hsieh EWY. Decoding the Human Genetic and Immunological Basis of COVID-19 mRNA Vaccine-Induced Myocarditis. J Clin Immunol. 2022 Oct;42(7):1354-1359. doi: 10.1007/s10875-022-01372-9. Epub 2022 Oct 8.PMID: 36207567

Campbell TM, Liu Z, Zhang Q, Moncada-Velez M, Covill LE, Zhang P, Alavi Darazam I, Bastard P, Bizien L, Bucciol G, Lind Enoksson S, Jouanguy E, Karabela ŞN, Khan T, Kendir-Demirkol Y, Arias AA, Mansouri D, Marits P, Marr N, Migeotte I, Moens L, Ozcelik T, Pellier I, Sendel A, Şenoğlu, S, Shahrooei M, Smith CIE, Vandernoot I, Willekens K, Kart Yaşar K; COVID Human Genetic Effort, Bergman P, Abel L, Cobat A, Casanova JL, Meyts I, Bryceson YT. Respiratory viral infections in otherwise healthy humans with inherited IRF7 deficiency. J Exp Med. 2022 Jul 4;219(7):e20220202. doi: 10.1084/jem.20220202. Epub 2022 Jun 7.PMID: 35670811

Zhang Q, Pizzorno A, Miorin L, Bastard P, Gervais A, Le Voyer T, Bizien L, Manry J, Rosain J, Philippot Q, Goavec K, Padey B, Cupic A, Laurent E, Saker K, Vanker M, Särekannu K; COVID Human Genetic Effort; Etablissement Français du Sang Study Group; Constances Cohort; 3C-Dijon Study; Cerba HealthCare Group; Lyon Antigrippe Working Group; REIPI INF Working Group, García-Salum T, Ferres M, Le Corre N, Sánchez-Céspedes J, Balsera-Manzanero M, Carratala J, Retamar-Gentil P, Abelenda-Alonso G, Valiente A, Tiberghien P, Zins M, Debette S, Meyts I, Haerynck F, Castagnoli R, Notarangelo LD, Gonzalez-Granado LI, Dominguez-Pinilla N, Andreakos E, Triantafyllia V, Rodríguez-Gallego C, Solé-Violán J, Ruiz-Hernandez JJ, Rodríguez de Castro F, Ferreres J, Briones M, Wauters J, Vanderbeke L, Feys S, Kuo CY, Lei WT, Ku CL, Tal G, Etzioni A, Hanna S, Fournet T, Casalegno JS, Queromes G, Argaud L, Javouhey E, Rosa-Calatrava M, Cordero E, Aydillo T, Medina RA, Kisand K, Puel A, Jouanguy E, Abel L, Cobat A, Trouillet-Assant S, García-Sastre A, Casanova JL. Autoantibodies against type I IFNs in patients with critical influenza pneumonia. J Exp Med. 2022 Nov 7;219(11):e20220514. doi: 10.1084/jem.20220514. Epub 2022 Sep 16.PMID: 36112363

Perlin DS, Zafir-Lavie I, Roadcap L, Raines S, Ware CF, Neil GA. Levels of the TNF-Related Cytokine LIGHT Increase in Hospitalized COVID-19 Patients with Cytokine Release Syndrome and ARDS. mSphere. 2020 Aug 12;5(4):e00699-20. doi: 10.1128/mSphere.00699-20.PMID: 32817460

Gow NAR, Johnson C, Berman J, Coste AT, Cuomo CA, Perlin DS, Bicanic T, Harrison TS, Wiederhold N, Bromley M, Chiller T, Edgar K. The importance of antimicrobial resistance in medical mycology. Nat Commun. 2022 Sep 12;13(1):5352. doi: 10.1038/s41467-022-32249-5.PMID: 36097014

Donato ML, Park S, Baker M, Korngold R, Morawski A, Geng X, Tan M, Ip A, Goldberg S, Rowley S, Chow K, Brown E, Zenreich J, McKiernan P, Buttner K, Ullrich A, Long L, Feinman R, Ricourt A, Kemp M, Vendivil M, Suh H, Balani B, Cicogna C, Sebti R, Al-Khan A, Sperber S, Desai S, Fanning S, Arad D, Go R, Tam E, Rose K, Sadikot S, Siegel D, Gutierrez M, Feldman T, Goy A, Pecora A, Biran N, Leslie L, Gillio A, Timmapuri S, Boonstra M, Singer S, Kaur S,

Park S, Perlin DS, Fitzgerald S, Petraitis V, Walsh TJ. Focused multivector ultraviolet (FMUV) technology rapidly eradicates SARS-CoV-2 in-vitro: Implications for hospital disinfection of COVID-19 environments. Am J Infect Control. 2022 Jul;50(7):828-830. doi: 10.1016/j.ajic.2022.02.001. Epub 2022 Feb 11.PMID: 35151772

Daneshnia F, de Almeida Júnior JN, Arastehfar A, Lombardi L, Shor E, Moreno L, Verena Mendes A, Goreth Barberino M, Thomaz Yamamoto D, Butler G, Perlin DS, Colombo AL. Determinants of fluconazole resistance and echinocandin tolerance in C. parapsilosis isolates causing a large clonal candidemia outbreak among COVID-19 patients in a Brazilian ICU. Emerg Microbes Infect. 2022 Dec;11(1):2264-2274. doi: 10.1080/22221751.2022.2117093.PMID: 36066554

Dhanyalayam D, Thangavel H, Lizardo K, Oswal N, Dolgov E, Perlin DS, Nagajyothi JF. Sex Differences in Cardiac Pathology of SARS-CoV2 Infected and Trypanosoma cruzi Co-infected Mice. Front Cardiovasc Med. 2022 Mar 11;9:783974. doi: 10.3389/fcvm.2022.783974. eCollection 2022.PMID: 35369283

Arastehfar A, Ünal N, Hoşbul T, Alper Özarslan M, Sultan Karakoyun A, Polat F, Fuentes D, Gümral R, Turunç T, Daneshnia F, Perlin DS, Lass-Flörl C, Gabaldón T, Ilkit M, Nguyen MHCandidemia Among Coronavirus Disease 2019 Patients in Turkey Admitted to Intensive Care Units: A Retrospective Multicenter Study. Open Forum Infect Dis. 2022 Feb 13;9(4):ofac078. doi: 10.1093/ofid/ofac078. eCollection 2022 Apr.PMID: 35345665

Mathema B, Chen L, Wang P, Cunningham MH, Mediavilla JR, Chow KF, Luo Y, Zhao Y, Composto K, Zuckerman J, Zody MC, Wilson N, Lee A, Oschwald DM, Liu L, Iketani S, Germer S, Fennessey S, Wang M, Kramer Y, Toole P, Maniatis T, Ho DD, Perlin DS, Kreiswirth BN Genomic Epidemiology and Serology Associated with a SARS-CoV-2 R.1 Variant Outbreak in New Jersey. mBio. 2022 Oct 26;13(5):e0214122. doi: 10.1128/mbio.02141-22. Epub 2022 Aug 23.PMID: 35997285

Liu L, Iketani S, Guo Y, Reddem ER, Casner RG, Nair MS, Yu J, Chan JF, Wang M, Cerutti G, Li Z, Morano NC, Castagna CD, Corredor L, Chu H, Yuan S, Poon VK, Chan CC, Chen Z, Luo Y, Cunningham M, Chavez A, Yin MT, Perlin DS, Tsuji M, Yuen KY, Kwong PD, Sheng Z, Huang Y, Shapiro L, Ho DD. An antibody class with a common CDRH3 motif broadly neutralizes sarbecoviruses. Sci Transl Med. 2022 May 25;14(646):eabn6859. doi: 10.1126/scitranslmed.abn6859. Epub 2022 May 25.PMID: 35438546

Jain S, Rego S, Park S, Liu Y, Parn S, Savsani K, Perlin DS, Dakshanamurthy S. RNASeq profiling of COVID19-infected patients identified an EIF2AK2 inhibitor as a potent SARS-CoV-2 antiviral. Clin Transl Med. 2022 Nov;12(11):e1098. doi: 10.1002/ctm2.1098.PMID: 36321336

2021

Mitchell MI, Ben-Dov IZ, Liu C, Ye K, Chow K, Kramer Y, Gangadharan A, Park S, Fitzgerald S, Ramnauth A, Perlin DS, Donato M, Bhoy E, Manouchehri Doulabi E, Poulos M, Kamali-Moghaddam M, Loudig O.J Extracellular Vesicle Capture by AnTibody of CHoice and Enzymatic Release (EV-CATCHER): A customizable purification assay designed for small-RNA biomarker identification and evaluation of circulating small-EVs. Extracell Vesicles. 2021 Jun;10(8):e12110. doi: 10.1002/jev2.12110. Epub 2021 Jun 3.PMID: 34122779

Zhao Y, Lee A, Composto K, Cunningham MH, Mediavilla JR, Fennessey S, Corvelo A, Chow KF, Zody M, Chen L, Kreiswirth BN, Perlin DS. A novel diagnostic test to screen SARS-CoV-2 variants containing E484K and N501Y mutations. Emerg Microbes Infect. 2021 Dec;10(1):994-997. doi: 10.1080/22221751.2021.1929504.PMID: 33977858

Chen XQ, Xing Z, Chen QD, Salvi RJ, Zhang X, Tycko B, Mobley WC, Yu YE. Mechanistic Analysis of Age-Related Clinical Manifestations in Down Syndrome. Front Aging Neurosci. 2021 Jul 1;13:700280. doi: 10.3389/fnagi.2021.700280. eCollection 2021.

Fanning SL, Korngold R, Yang Z, Goldgirsh K, Park S, Zenreich J, Baker M, McKiernan P, Tan M, Zhang B, Donato ML, Perlin DS Elevated cytokines and chemokines in peripheral blood of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasma. PLoS Pathog. 2021 Oct 29;17(10):e1010025. doi: 10.1371/journal.ppat.1010025. eCollection 2021 Oct.PMID: 34714894

Chen L, Zody MC, Di Germanio C, Martinelli R, Mediavilla JR, Cunningham MH, Composto K, Chow KF, Kordalewska M, Corvelo A, Oschwald DM, Fennessey S, Zetkulic M, Dar S, Kramer Y, Mathema B, Germer S, Stone M, Simmons G, Busch MP, Maniatis T, Perlin DS, Kreiswirth BN.mSphere. Emergence of Multiple SARS-CoV-2 Antibody Escape Variants in an Immunocompromised Host Undergoing Convalescent Plasma Treatment. 2021 Aug 25;6(4):e0048021. doi: 10.1128/mSphere.00480-21. Epub 2021 Aug 25.PMID: 34431691

Richards E, Perlin DS. Clinical and laboratory evaluation of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasma. JCI Insight. 2021 Mar 22;6(6):e143196. doi: 10.1172/jci.insight.143196.PMID: 33571168

Mathema B, Chen L, Chow KF, Zhao Y, Zody MC, Mediavilla JR, Cunningham MH, Composto K, Lee A, Oschwald DM, Germer S, Fennessey S, Patel K, Wilson D, Cassell A, Pascual L, Ip A, Corvelo A, Dar S, Kramer Y, Maniatis T, Perlin DS, Kreiswirth BN Postvaccination SARS-COV-2 among Health Care Workers in New Jersey: A Genomic Epidemiological Study. Microbiol Spectr. 2021 Dec 22;9(3):e0188221. doi: 10.1128/Spectrum.01882-21. Epub 2021 Nov 17.PMID: 34787439

Kordalewska M, Guerrero KD, Garcia-Rubio R, Jiménez-Ortigosa C, Mediavilla JR, Cunningham MH, Hollis F, Hong T, Chow KF, Kreiswirth BN, Perlin DS. Antifungal Drug Susceptibility and Genetic Characterization of Fungi Recovered from COVID-19 Patients. J Fungi (Basel). 2021 Jul 11;7(7):552. doi: 10.3390/jof7070552.PMID: 34356931

Zhao Y, Cunningham MH, Mediavilla JR, Park S, Fitzgerald S, Ahn HS, Li X, Zhan C, Hong T, Munk G, Chow KF, Perlin DS. Diagnosis, clinical characteristics, and outcomes of COVID-19 patients from a large healthcare system in northern New Jersey. Sci Rep. 2021 Feb 23;11(1):4389. doi: 10.1038/s41598-021-83959-7.PMID: 33623090

Ghazanfari M, Arastehfar A, Davoodi L, Yazdani Charati J, Moazeni M, Abastabar M, Haghani I, Mirzakhani R, Mayahi S, Fang W, Liao W, Nguyen MH, Perlin DS, Hoenigl M, Pan W, Hedayati MT. Pervasive but Neglected: A Perspective on COVID-19-Associated Pulmonary Mold Infections Among Mechanically Ventilated COVID-19 Patients. Front Med (Lausanne). 2021 Jun 14;8:649675. doi: 10.3389/fmed.2021.649675. eCollection 2021.PMID: 34195207

Arastehfar A, Shaban T, Zarrinfar H, Roudbary M, Ghazanfari M, Hedayati MT, Sedaghat A, Ilkit M, Najafzadeh MJ, Perlin DS. Candidemia among Iranian Patients with Severe COVID-19 Admitted to ICUs. J Fungi (Basel). 2021 Apr 8;7(4):280. doi: 10.3390/jof7040280.PMID: 33917967

2020

Tan X, Krel M, Dolgov E, Park S, Li X, Wu W, Sun YL, Zhang J, Khaing Oo MK, Perlin DS, Fan X. Rapid and quantitative detection of SARS-CoV-2 specific IgG for convalescent serum evaluation. Biosens Bioelectron. 2020 Dec 1;169:112572. doi: 10.1016/j.bios.2020.112572. Epub 2020 Sep 3.PMID: 32916610

Arastehfar A, Carvalho A, Nguyen MH, Hedayati MT, Netea MG, Perlin DS, Hoenigl M.J COVID-19-Associated Candidiasis (CAC): An Underestimated Complication in the Absence of Immunological Predispositions? Fungi (Basel). 2020 Oct 8;6(4):211. doi: 10.3390/jof6040211.PMID: 33050019

Grants related to COVID-19

1U19AI1714010
Perlin (co-PI), Rice (co-PI) 05/17/2022 – 5/16/2027
NIH/NIAID
Metropolitan AntiViral Drug Accelerator
Total Award: $108,549,173; $65,141,731 (First 3 years only)

3U19AI142731-02S
Perlin (PI) 08/25/2020 – 04/30/2024
NIH/NIAID
A CETR-based partnership accelerator for rapid drug development targeting SARS-CoV-2 and pan-CoVs
$619,850

W81XWH2110064
Donato (co-PI) Perlin (co-PI) 2/01/2021 – 1/31/2023 DOD USAMRAA
Phase II Randomized Study of Convalescent Plasma as Treatment for Subjects with Early COVID-19 Infection
$5,492,928

3R01HD090180-05S1
Tycko (PI) 09/04/2020-06/30/2023
NIH
Epigenetics of Down Syndrome- COVID Supplement
$696,828

3R01HD090180-05S1
Kreiswirth (PI) 09/04/2020-06/30/2023
NIH
Epigenetics of Down Syndrome- COVID Supplement
$696,828

MRCK_CDI
Kreiswirth (PI) Kordalewska (co-PI)12/16/2020-12/31/2022
Merck
Drug resistance profiles of secondary bacterial and fungal isolates from super-infections in hospitalized COVID-19 patients
$111,095

PHLP21CHT004
Perlin (PI) Chow (co-PI) 10/1/2020-6/30/2023
NJ Department of Health
Expanding SARS-CoV-2 Testing in Hospitals/Clinical Laboratories in New Jersey
$9,576,792

3R01DK127274-02S1
Nagajyothi (PI) Scherer (co-PI) 6/01/2022-5/31/2023
NIH
Leptin Reduction as a Potent Mitigative Strategy for the Treatment of PASC
$275,874

P22-000876
Kreiswirth (PI) 11/1/2022-4/30/2024
New York Community Trust
Monitoring SARS-CoV-2 Evolution in the NYC Population
$344,000

Patent Applications

CDI Enhanced COVID-19 Test
Inventors: Yanan Zhao, Steven Park, David S. Perlin
WO US CN AU CA AU2021231803A1  Hackensack Meridian Health, Inc.
Priority 2020-03-05 • Filed 2021-03-03 • Published 2022-10-27
Application No.: 17/100,289; Filed: November 20, 2020
August 10, 2021 with the United States Patent and Trademark Office (“USPTO”) and was assigned U.S. Serial No.: 63/231,424.

A method for detecting a novel coronavirus, severe acute respiratory syndrome-CornaVirus-2 (SARS-CoV-2 or COVID-19) in a sample, comprising: a) collecting a sample suspected of comprising the novel coronavirus; b) analyzing at least a first portion of the sample for one region in a SARS-CoV-2 nucleocapsid (N) gene using an N2 assay; c) analyzing at least a second portion of the sample for universal detection of SARS coronaviruses envelop (E) gene using an (E) assay; and d) analyzing at least a third portion of the sample to detect human RNase P (RP) using -a human RPP30 adenovirus (H-RPP30 or RP) assay; and e) combining and evaluating results of the N2, E and RP assays to determine a presence or an absence of the novel coronavirus.

CDI rapid test for covid-19 variants of concern
Inventors: Yanan Zhao, Liang Chen, David S. Perlin
US202163171377P
WO WO2022216821A1  Hackensack Meridian Health, Inc.
Priority 2021-04-06 • Filed 2022-04-06 • Published 2022-10-13
PCT/US2022/023670

A method, detection assay, and kit for rapidly detecting mutations of the SARS-CoV-2 virus includes preparing a detection assay, performing an asymmetric real time- polymerase chain reaction (RT-PCR) on the detection assay using a Mic Real Time PCR cycler, and analyzing a melting curve to detect peaks at a 484 and a 501 codon of a gene, or detect peaks at a 452 codon and a 478 codon of a gene. The method, detection assay, and kit also provides for detecting the SARS-CoV-2 virus and mutations thereof. Disclosed is a high-throughput test that can detect multiple variants of the SARS-CoV-2 virus within two-and-a-half hours, and is a major advance in tracking the virus and in treating patients. The test can detect UK, Brazil, South African, and Omicron variants, as well as others containing, for example, a key E484K mutation, which are gaining prominence as the virus evolves.