NONPROFIT, NONPARTISAN PLATFORM OF ACCURATE SCIENCE-BASED SOLUTIONS TO COVID-19

Calbiotech

Business Name:
Calbiotech
Business Genre:
Business Description:

Immunoassay development company that merged with Erba Diagnostics Ltd., offering a comprehensive suite of clinical testing products to small hospitals, reference labs, and physician clinics in the developed and emerging markets. CalBiotech specializes in ELISA (Enzyme-Linked Immunosorbent assay) and CLIA (Chemiluminscent Immunoassay Technology) assays and has over 200 products which are distributed to over 80 countries globally [1].

City:
El Cajon
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
58 serum samples collected from previously RT-PCR confirmed COVID-19 patients were tested. 57 of the tests returned a positive result and 1 negative result. 107 Normal healthy patients with samples collected before COVID-19 outbreak (prior to December 2019) were tested. 105 tested negative and 2 tested positive. The diagnostic sensitivity is reported to be 98.3% and diagnostic specificity is 98.1%.No interference was observed with Haemoglobin, Bilirubin, Biotin or IgM [2].
Complimentary Products Needed to Perform Test:
Ready to use reagents supplied in kit [2]. Kit is compatible with any automated ELISA analyzer [4]
Setting of Care:
N/A? Seems like a clinical lab but not specifically stated.
Current Status / Clinical Development Stage / Expected Milestones:
“Notification status by the FDA, under product code QKO. Not FDA approved. Submission number is D386770 [2]. EUA approval pending [4].”
Funding & Ownership :
Company joined the Erba Diagnostics Ltd. group in 2017 [1]. ERBA Diagnostics is a privately owned for profit company. M&A status. Amount undisclosed [5].
Business Model:
They partner with biotech, pharma and CROs and providing contract manufacturing and assay development services. They specialize in ELISA and CLIA assays for human and animal research. [1]
IP:
ErbaLisa for HIV Gen 3 is a third generation ELISA for the detection of total antibodies (IgG, IgM, & IgA) against HIV 1 & 2 [6]. Unsure if the same ErbaLisa patent applies for the COVID-19 IgG test.
History & Origins :
Calbiotech was founded in 1998 [8].The company specializes in immunoassay manufacturing and development for hormones, infectious disease, cancer, autoimmune disorders, etc. They also provide contract manufacturing and custom assay services. In 2017, they joined the Erba Diagnostics Ltd. group, a fully integrated global in vitro diagnostics company, offering a comprehensive suite of clinical testing [1].
Date EUA Issued:
“Notification Status by the FDA, under product code QKO. Submission number is D386770 [2]. EUA following soon [4].”
Sources:
1. https://www.calbiotech.com/about 2. https://erbalisacovid19.erbamannheim.com/ 3. https://www.medicaldevice-network.com/news/erba-mannheim-covid-19-antibody-kits/ 4. https://erbamannheim.com/article/press/211 5. https://www.crunchbase.com/organization/erba-diagnostics-mannheim#section-overview 6. https://transasia.co.in/reagent/blood-banking/erbalisa-hiv-gen-3/208 7. https://www.wsj.com/market-data/quotes/ERBA/company-people/executive-profile/134773084 8. https://www.linkedin.com/company/calbiotech-inc_4/about/
Organization:
“For parent company (ERBA Mannheim) Suresh Hassanand Vazirani (Executive Chairman), David Barkay (Chief Executive Officer), Jean Felix LaCroix, (Treasurer, Chief Financial & Accounting Officer), Nikhil Kumar Suresh Vazirani (Director), Gerald E. Gallwas (Independent Director), David M. Templeton (Independent Director) [7]”
No. Tests Per Day:
96 tests/ 50 minutes. So for 24 hours (1440 minutes), (96 x 1440)/50 tests = 2764.8 tests.
Time to Result:
50 minute incubation time [2]
Test Sample Type:
Serum from blood [2]
Technology Overview:
Detects IgG antibody levels to identify how many people have been infected and may have developed an immunity [3]. Test uses Indirect ELISA using recombinant Spike subunit antigen [2].
Testing Type:
Serum IgG test. Qualitative and semi- quantitative assay [2-4].
Test Category:
SEROLOGY
Test Name:
ErbaLisa COVID-19 IgG [2-4]
Clinical Application & Need:
Detect current or prior exposure to COVID-19 [2-4]
Age of Company:
Calbiotech was founded in 1998 [8]. They joined the Erba Diagnostics Ltd. groupin 2017 [1].

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