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

Rheonix, Inc

Business Name:
Rheonix, Inc
Business Genre:
Business Description:

The company was founded in 2008 to provide molecular testing across various markets, including diagnostics labs, food and beverage applications and next-generation sequencing sample preparations, in a low-cost, packed format. [2]

City:
Ithaca
State:
NY
Country:
USA
Data/Evidence of Effectiveness:
Health provider fact sheet states that while the test has been designed to reduce likelihood of false positive results, both false positive and false negative results are possible. Consideration of COVID-19 exposure and associated symptoms are recommended as secondary considerations to the test result. [4] Kit contains positive, negative, and internal controls, and an external RNA positive control is recommended (ex: AccuPlex™ SARS-CoV-2 Reference Material Kit (Material number 0505-0126)) [5]. Reported “100% (91.8-100, 95% CI) diagnostic sensitivity and 100% (93.8-100, 95% CI) diagnostic specificity.” [7]
Complimentary Products Needed to Perform Test:
Rheonix Encompass MDx® Workstation, External Control (Positive/Negative) [4]
Setting of Care:
permitted use under EUA in authorized laboratories; suited for low to medium-throughput labs, local and regional health networks. [4] [5]
Current Status / Clinical Development Stage / Expected Milestones:
The product is under EUA and the shipment is available. The company is collaborating with local hospitals Cayuga Health. The testing site can run 200 samples per day with capacity of up to 1000 daily tests. [5] [6]
Funding & Ownership :
Private (Venture $86.7M over 7 rounds) [1]
Business Model:
The company designed and manufactured the automated PCR platform for integrated diagnostics: the Encompass Workstations and the Rheonix CARD Cartridge. The work station is also applied to testing spoiled drinks (beer) by detecting microorganism gene signature. [7] [8]
IP:
Parts of the automated platform is patented. [9]
History & Origins :
The CoV-19 diagnostics kit is the company’s only product for infectious disease testing. The company has not designed any other cartridge for biomedical diagnostics/research. [7]
Date EUA Issued:
04/29/2020 [3]
Sources:
[1] https://www.crunchbase.com/organization/rheonix#section-overview [2] https://rheonix.com/rheonix-overview/abouthistory/ [3] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations [4] https://rheonix.com/wp-content/themes/RHE2016/includes/covid/Rheonix_COVID-19_MDx_Assay_Package_Insert.pdf [5] https://rheonix.com/rheonix-inc-receives-fda-emergency-use-authorization-rapid-fully-automated-molecular-covid-19-test/ [6]https://cornellsun.com/2020/05/03/cornell-alum-brings-same-day-results-to-ithacas-covid-19-testing-site/ [7] https://rheonix.com/research-clinical/our-technology/ [8] https://rheonix.com/food-beverage-testing/beer-spoilage-testing/ [9] https://patents.google.com/?assignee=rheonix&oq=rheonix
Organization:
Gregory J. Galvin(Founder, CEO and Chairman), Tony Eisenhut(President) [1]
Time to Result:
24 samples less than 5 hours on Rheonix Encompass MDx® Workstation [4]
Test Sample Type:
nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage (BAL) fluid samples [4]
Technology Overview:
PCR amplification targeting N1 nucleocapsid protein gene [4]
Testing Type:
nucleic acid detection
Test Category:
RT-PCR
Test Name:
Rheonix COVID-19 MDx Assay
Clinical Application & Need:
acute infection

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