Diagnostic Deals

How Curative & KorvaLabs Created a Successful COVID-19 Testing Lab in Less than a Month

Say what you will about the current state and availability of COVID-19 diagnostic testing, the energetic, imaginative and speedy response by certain segments of the lab industry has been nothing short of heroic. A case in point is the collaboration between KorvaLabs and Curative to launch a COVID-19 testing firm in Southern California in record time.

Creating the Partnership

The story began in December 2019 when sepsis testing lab Shield Bio ran out of capital and had to close down. Shield CEO Fred Turner responded by founding Curative, Inc. The original plan was to focus on sepsis; but when the pandemic hit, it shifted gears and sought to create a COVID-19 testing lab. What it needed was an existing lab in the region that had the testing equipment, facility and capability to quickly adapt to COVID-19 testing.

KorvaLabs fit the bill. The San Dimas-based high-throughput lab specializing in sports drug testing was willing to partner. KorvaLabs would supply the infrastructure and Curative the infectious disease testing expertise.

Developing the Assay

The next thing the partners needed was a laboratory developed SARS-CoV-2 test. Within 10 days, that assay was created. The team brought the test to KorvaLabs, validated it and began performing it five days later. And on April 17, the Curative-Korva SARS-CoV2 assay received Emergency Use Authorization (EUA) from the FDA.

What distinguishes the Curative-Korva assay from other COVID-19 tests is its capacity to detect SARS-CoV-2 nucleic acids in not only oropharyngeal, nasopharyngeal and nasal swabs, but also oral fluid specimens, an extremely valuable trait given the shortages of nasal swabs. Of equal advantage was that samples can be self-collected with almost any type of sterile swab and without need of any special collection device. Using Zymo Research’s DNA/RNA Shield to stabilize the sample RNA, specimens are transported, stored at room temperature and tested within 24 hours of collection.

Launching the COVID-19 Testing Lab

Because the lab was set up exclusively for COVID-testing, the team was able to arrange workflows to avoid other bottlenecks, e.g., use of a Norgen Biotek kit allowing for either manual or robotic extraction. Doing just COVID-19 testing also enabled the lab to be flexible in finding reagents, extraction kits and swabs.

The lab is now doing up to 5,000 tests per day, including first responders, and hasn’t yet reached its testing capacity. Meanwhile, Los Angeles City and County drive-through test sites are also using the Curative-KorvaLab test service.

Takeaway

Four weeks. That’s all it took for Curative and KorvaLabs to partner, develop an assay, secure FDA approval and open a COVID-19 testing lab providing 5,000 tests per day. It’s a remarkable story and, let’s hope, an inspiration and model for many others around the country.


Here’s a summary of the key strategic diagnostic deals announced in April 2020:

STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS
Partner 1 Partner(s) 2+ Deal Summary
Merck Institute for Systems Biology
  • Objective: Develop COVID-19 vaccines and treatments
  • Dynamic: Research collaboration to discover and define to uncover and define molecular mechanisms of SARS-CoV-2 infection and COVID-19 development
Qiagen Gilson
  • Objective: Enable researchers to limit operator-independent variation in manual nucleic acid extraction results and improve workflow traceability
  • Dynamic: Research collaboration integrating integrate Gilson’s Trackman Connected digital bench tools + Qiagen’s manual nucleic acid extraction kits
Leinco Technologies Vanderbilt University Medical Center
  • Objective: Develop immunodiagnostic test to detectSARS-CoV-2
  • Dynamic: Leinco to scale up production of its most promising antibodies to co-develop a test with antibody sequences discovered in Vanderbilt Vaccine Center
CareDx Johns Hopkins University
  • Objective: Launch of Allosure Lung Allograft Remote Monitoring (ALARM) to measure impact of AlloSure and RemoTraC on lung transplant patients
  • Dynamic: CareDx’s RemoTraC is a remote home-based blood draw product using mobile phlebotomy for AlloSure and AlloMap surveillance tests
Mission Bio Agilent Technologies
  • Objective: Comarket Mission Bio’s Tapestri single-cell analysis platform with unspecified Agilent products
  • Dynamic: Deal targets North America and follows 2019 deal between partners to market Tapestri in China
ArcherDX Premier Applied Sciences
  • Objective: Provide personalized genomic testing
  • Dynamic: Premier to identify eight of its member institutions to implement ArcherDX Stratafide test, in a research-use-only capacity as part of retrospective study to evaluate its sequencing performance compared to other tests
Indivumed Personalis
  • Objective: Develop personalized oncology products
  • Dynamic: Integrate Indivumed’s IndivuType multiomic cancer database with genome and transcriptome-level data collected for Personalis’ advanced cancer genomics technology
Curetis (subsidiary of Opgen) Karolinska Institute
  • Objective: Identify bacterial co-infections in patients with COVID-19 pneumonia
  • Dynamic: Utilize Curetis’ Unyvero system and Hospitalized Pneumonia panel
True Diagnostics Veravas
+
Infectolab Americas
  • Objective: Develop and commercialize rapid, point-of-care SARS-CoV-2 immunoassay
  • Dynamic: VeraTest SARS-CoV-2 IgA/IgG Rapid Test for detecting immunoglobulin A and G antibodies against SARS-CoV-2 in blood within 15 minutes to combine True Diagnostics’ TrueDx lateral flow immunoassay technology with Veravas’ VeraPrep clean and VeraPrep capture technologies
Nimble Therapeutics Svar Life Science
  • Objective: Develop tests for autoimmune diseases using biomarkers discovered using Nimble’s human proteome immunoprofiling technology starting with rheumatoid arthritis
  • Dynamic: Nimble to receive undisclosed upfront payment as well as milestone payments and royalties on product sales
ProMis Neurosciences University of British Columbia (UBC)
  • Objective: Develop test to assess immunity to SARS-CoV-2
  • Dynamic: UBC to lead research team seeking to create high-throughput serological assay that can detect presence of SARS-CoV-2 antibodies for identifying who has virus immunity and who remains at risk for infection
Bosch Healthcare Solutions Randox Laboratories
  • Objective: Develop fully-automated coronavirus test for Bosch’s point-of-care Vivalytic system
  • Dynamic: Expansion of current molecular diagnostic partnership with new test to be part of a viral respiratory tract infection (VRI) panel testing for nine other viruses, including influenza A and B and all known coronaviruses, with turnaround time of 2.5 hours
Novacyt BioType Diagnostic
  • Objective: Manufacture Novacyt’s COVID-19 test kits
  • Dynamic: Dresden, Germany-based BioType has already delivered first batches of for final assembly to Primerdesign, Novacyt’s UK-based molecular diagnostics division
Oxgene Native Antigen Company
  • Objective: Increase antigen manufacturing capabilities reagents for development of SARS-CoV-2 diagnostics and vaccines
  • Dynamic: Leverage Oxgene’s Adenoviral Protein Machine technology to deliver high-purity recombinant proteins
Amgen Adaptive Biotechnologies
  • Objective: Develop human antibody-based treatments for COVID-19
  • Dynamic: Mutually exclusive partnership combining Adaptive’s immune repertoire sequencing technology with Amgen’s expertise in antibody therapy development to discover and develop fully human neutralizing antibodies targeting SARS-CoV-2
Zymo Research Tecan
  • Objective: Launch ready-to-go product to streamline viral DNA/RNA extraction from nasopharyngeal swasbs, oropharyngeal swabs, saliva, sputum, plasma and serum
  • Dynamic: Use Tecan’s DreamPrep NAP workstation, featuring Zymo’s Quick-DNA/RNA Viral MagBead Kit, to simplify the process by offering pre-loaded scripts that are being validated for COVID-19 assays by high complexity testing labs
Sophia Genetics Paragon Genomics
  • Objective: Launch new product combining Sophia’s analytics services to Paragon’s recently launched CleanPlex SARS-CoV-2 panel for COVID-19 detection
  • Dynamic: Expand existing partnership by combining Paragon’s new panel reagent kit for whole-genome sequencing of novel coronavirus with Sophia’s cloud-based platform
DISTRIBUTION, SALES & MARKETING AGREEMENTS
Property Owner Distributor Deal Summary
Becton Dickinson
+
BioMedomics
Henry Schein
  • Products: BD/BioMedomics’ commercial point-of-care SARS-CoV-2 test
  • Territory: US
  • Exclusive
Biolidics Aytu BioScience
  • Products: At least 1.25 million of Biolidics’ serology COVID-19 IgG/IgM Rapid Tests
  • Territory: US
  • Exclusive
Oncocyte CORE Diagnostics
  • Products: Oncocyte’s DetermaRx test
  • Territory: India, Middle East, Africa
Acumen Research Laboratories United Global Alliance
  • Products: Acumen’s Acu-Corona 2.0 test kit
  • Territory: Africa and international healthcare organizations
Predictive Laboratories (subsidiary of Predictive Technology) Wellgistics
  • Products: Predictive’s point-of-care Assurance AB COVID-19 IgM/IgG Rapid Antibody Test
  • Territory: US
  • Exclusive
Credo Diagnostics Biomedical A. Menarini Diagnostics
  • Products: Credo’s SARS-CoV-2 kit and other assays for respiratory syncytial virus and Group Strep A diagnosis
  • Territory: Undisclosed
  • Exclusive
LICENSES
Licensor Licensee Deal Summary
Yale University Elysium Health Elysium acquires exclusive rights to Yale’s DNA methylation biomarkers of aging and cellular senescence
Yale University Veracyte Veracyte acquires exclusive rights to Yale’s genomic test for predicting disease progression in patients with idiopathic pulmonary fibrosis (IPF) for use on the nCounter Flex Analysis System, which Veracyte exclusively licensed from NanoString
Mount Sinai’s Icahn School of Medicine Biomerica Two separate licensing agreements for for technologies related to a lab-based serological test for SARS-CoV-2
ERS Genomics Axxam Axxam gains access to ERS’ CRISPR-Cas9 patent portfolio to support its integrated discovery service platform
SUPPLY, SERVICE & TESTING AGREEMENTS
Supplier/Servicer Client/User Deal Summary
Health Service Executive Genomics Medicine Ireland + National Virus Reference Laboratory HSE to supply reagents enabling GMI and NVRL to ramp up SARS-CoV-2 testing
Twist Bioscience Vanderbilt University Medical Center Twist to supply VUMC with antibodies and synthetic DNA to support development of potential COVID-19 therapies

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