As a global leader in precision medicine, Avellino focuses on innovative and cutting-edge tools and therapies, empowering healthcare professionals to achieve more for their patients and practices.
The Avellino SARS-CoV-2/COVID-19 Test (AvellinoCoV2) is a non-invasive, swab based test used to detect the SARS-CoV-2 virus, a strong indicator of the patient having the COVID-19 disease. A positive result generally indicates an active infection, while a negative result should not be used as the sole basis for treatment or other patient management decisions.
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
AvaGen is the first and leading personalized genetic eye test that quantifies the risk or presence of corneal conditions caused by genetic disorders.
Personalized genetic data empowers eyecare professionals to accurately quantify keratoconus risk and the presence of corneal dystrophies for individual patients and families
Genetic data provides objective information about asymptomatic and symptomatic patients that is unattainable with advanced ocular measurements and provides a 360˚ view when coupled with environmental factors
Genetic data enables early diagnosis, assessment, and confident decisions about corneal management and procedures
Working to deliver the full clinical potential of genetic data.
As a technology pioneer, our mission is to empower healthcare professionals to achieve accurate and timely solutions. Avellino’s full-service model for diagnostics and therapy ensures that genetic data is the basis for development and a continual confirmation tool for the success of all therapies.
Filling an unmet need in diagnostics
Keratoconus is a corneal ectatic disorder, characterized by genetic heterogeneity, requiring a comprehensive sequencing method able to detect rare DNA variants.1 At Avellino, we recognized that earlier identification of keratoconus was an unmet need that needed to be addressed.
A recent study found keratoconus prevalence to be much higher than previously estimated, at 265 cases per 100,000 (1 in 375) within a population group of 4.4million.2 In certain population groups, keratoconus incidence can be as high as 1 in 20.3
Utilizing a custom panel and next-generation sequencing, AvaGen is able to detect rare variants that are integral to the etiology of complex, multifactorial diseases, such as keratoconus.
Discover more about AvaGen for optimal eyecare.
1. Data on file, Avellino Labs USA, Inc.
2. Godefrooij DA, de Wit GA, Uiterwaal CS, et al. Am J Ophthalmol. 2017;175:169-172.
3. Torres-Netto, EA, Al-Otaibi WM, Hafezi NL, et al. Br J Opthalmol. 2018;102(10):1436-1441.