Overview facts about hVIVO COVID Clear & FAQ

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials.

Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. Which offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development.

The Company has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. Open Orphan comprises of two commercial specialist CRO services businesses (hVIVO and Venn) and is developing an early stage orphan drug genomics data platform business.



Overview facts

• The MosaiQ™ COVID-19 Antibody Microarray is a serological test for the detection of antibodies to SARS-COV-2

• The assay is built to detect IgG & IgM directed at SARS-COV-2

• The test is qualitative, giving positive or negative results

• The microarray is run on the MosaiQ™ by Quotient instrument.

• Up to 132 probes available per microarray

• Up to 3,000 microarrays per instrument per day

• First result delivered in <35 minutes, with subsequent results every 24 seconds • It offers continuous sample loading (120 samples)

Frequently Asked Questions

• What type of test are being offered?

Blood draw-based testing as it is more sensitive and specific.

• What platform does this test use?

Quotients MosaiQ™ 125 instrument, which uses a microarray technology that also has the capability as a multiplex system for use beyond COVID-19.

• What evidence of validation exist for the assay?

The assay is completed using a CE IVD marked antibody detection microarray and has subsequently complete internal testing at hVIVO.

• Is it CE marked?

Yes, it is the first CE IVD marked assay for COVID-19 Antibody testing. CE IVD mark achieved – 1st May 2020

• What is the sensitivity and specificity of our test?

SARS-CoV-2 = 100% sensitivity, 99.8% specificity based on 161 samples tested, 30 of which were positive sample

• How does it compare to the Roche test? What are the differences and advantages?

Roche is an Elecsys assay and Quotient MosaiQ™ 125 uses a microarray technology, also with capability as a multiplex system.

Roche Elecsys® Anti-SARS-CoV-2 is an immunoassay for the in-vitro qualitative detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma. Quotient MosaiQ detects IgG but also IgM for SARS-COV-2 o Roche claim of 100% accuracy in PHE report was for samples over 42 days post symptoms / positive PCR test. The MosaiQ COVID-19 Microarrays have can detect antibodies from 9 days post symptoms / positive PCR test

• What are the options for blood draw collection and shipping?

Through participants attending one of our partners/network of clinics o Direct clinical staff and shipping arranged by hVIVO at their place of business o Flexible option if business’s want to arrange their own clinical resource and arrange shipping themselves to save costs.

• What are the sample handling, processing requirements around the samples taken?

Sample can be collected into serum separation tubs, maintained are +4 degrees centigrade and shipped at ambient temperature to hVIVO laboratory where they will be centrifuged and loaded onto the instrument.

• What options are there for sample storage and shipment i.e. ambient, 2-4 degrees, frozen?

Sample can be shipped at ambient or +4 degrees C.

• What considerations around timeframe from blood draw to hVIVO receipt are there for the options mentioned above?

The maximum stability for these types of samples is 9 days. Preference is for samples to be shipped same day of collection.

• Are hVIVO using this test on their own staff?

Yes, the test has been offered to all hVIVO employees.

• What is the turnaround time from hVIVO receipt of sample to result reported to client?

Results will be reported within 48 hours

• How are the results managed and reported?

Results will be provided via one of our service partners and can either be as an individual result report or as a group of results for an employer.

• What is the max capacity of quotient i.e. availability of kits etc should we need to run this at max output?

Supply of kits has been confirmed by Quotient and is part of our partnership agreement. We have capacity for up to 3000 samples tested per day.

Twitter @OpenOrphan, @QuotientHQ, @hVIVO_UK

Company Website www.openorphan.com

Covid Clear

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