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

Atila Biosystems, Inc.

Business Name: Atila Biosystems, Inc.
Business Genre:
Business Description:

Diagnostics company focused on “developing novel chemistry for nucleic acid amplification and detection of clinical diagnostic applications.” [7].

City: Mountainview
State: CA
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 [3]. Includes internal, positive, and negative controls which must produce the expected result for a sample test to be considered valid [2]. Reported 100% positive and negative detection rates, though confidence intervals are not given [4].
Complimentary Products Needed to Perform Test: Internal Control (human Gapdh gene in clinical sample), Positive Template Control, Negative Template Control, other materail required but not included in kit outlined in Instruction For Use [2].
Setting of Care: “””Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.”” [2].”
Current Status / Clinical Development Stage / Expected Milestones: Not FDA cleared/approved; FDA approved to meet EUA criteria [2]. Under EUA, cGMP requirements have been waived [2]; for in vitro diagnosis of SARS-CoV-2 infection [2].
LOD: 4 copies/uL x 1000uL/mL= 4,000 copies/mL [4]
Funding & Ownership : Information not available
Business Model: Atila Biosystems develops and directly sells diagnostic kits for infectious diseases, cancer, and prenatal applications [6].
IP: AU2018313286A1(published 03-12-2020, status pending), Australian patent for “digital amplification with primers of limited nucelotide compostition.” [9].
History & Origins : Started in 2009, primarily develops diagnostics for infectious diseases, cancer, and prenatal applications [6, 7].
Date EUA Issued: 04/10/2020 [1]
Sources: [1]https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization [2] https://www.fda.gov/media/136872/download [3] https://www.fda.gov/media/136869/download [4]https://www.fda.gov/media/136870/download [5] https://atilabiosystems.com/our-products/covid-19/ [6] https://atilabiosystems.com/our-products/ [7]https://atilabiosystems.com/about-us/ [8] https://atilabiosystems.com/contact-us/ [9] https://patents.google.com/patent/AU2018313286A1/en?assignee=Atila+Biosystems+Incorporated
Organization: Information not avaliable
No. Tests Per Day: 94 tests/run x 1 run/1 hour x 24 hours/day=2256 tests/day
Time to Result: Sample-to-result in about 1 hour, up to 94 samples per run [5].
Test Sample Type: nasal, nasopharyngeal, and oropharyngeal swabs [2].
Technology Overview: detects presence of RNA originating from SARS-CoV-2 in samples taken from upper respiratory system [2]
Testing Type: qualitative viral RNA test, RT-PCR based with isothermal amplification [2]
Test Category: RT-PCR
Test Name: iAMP COVID-19 Detection Kit [1]
Clinical Application & Need: A positive result indicates the patient is actively infected with the virus, and assumed to be contagious [3]
Age of Company: 11 years old, founded in 2009 [7]

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