Product - Using Protein-DNA chimeras interactions that bind to various virus proteins/antibodies and use PCR to detect viral presence. We can design a protein attached to an oligonucleotide sequence that can be then amplified with PCR to detect presence of antibodies even in lower concentrations.[3]
Nanomaterial-assisted colorimetric aptasensors Colorimetric/optical aptasensors can also be used to detect viruses on surfaces to protect public spaces/grocery stores. X-aptamers - . Several X ligands can be added in a directed or random fashion to the aptamers to enhance their binding affinities to the target proteins. Possible computational experiments for SELEX (systematic evolution of ligands by exponential enrichment) for finding Aptamers that bind to viral proteins of COVID-19
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Find aptamers that bind to viral proteins or the antibodies (Peptides that bind to spike protein and attached to a oligonucleotide)
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PCR to amplify the oligonucleotides
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Maybe optical/colorimetric signal for at home diagnosis.
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Possible computational prediction experiments for aptamer design to targets
source -https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6618307/#B5
FDA Approval Timeline. Emergency Use Authorization (EUA) allows US to accelerate the approval process for diagnostics, therapeutics etc. It allows waiving of certain requirements such as good manufacturing practices, design etc. Using the EUA, developers can
- Get access to viral samples within one to three days
- FDA revised the process to allow labs to begin testing prior to FDA review of their validation data. But only 6 labs took advantage of this.
- FDA has a relaxed standard that allows tests to be made available based on less data than in non-urgent circumstances and allows for expedited FDA review
Approval process for diagnostics during non pandemic regulations
Typical approval process for invitro diagnostic devices depends on their class.
- Class I (low to moderate risk): general controls
- Class II (moderate to high risk): general controls and Special Controls - Typical diagnostic tests that don't use any new technology. You have to submit performance data, labeling etc to an FDA reviewer and the timeline is typically 6-12 months of back and forth. Pre-market notification (510k) is required before marketing. The FDA processes 510k submissions in 30-90 days
- Class III (high risk): general controls and Premarket Approval (PMA) - Typically for any diagnostic test that uses technologies. FDA review of an application for premarket approval is supposed to take six months
Why do so many of the essential genes have no known function
I found a couple of papers explaining some possible hypotheses for why we might non coding genes. One of them is that these regions could be under strong evolutionary pressure[1]. ENCODE project found that most of these non coding regions are available to the transcription factors - So maybe there even if the gene right now is "junk" or "Selfish" they can evolve to be useful.
In an age where scientists like us can design and build new organisms and viruses, what is acceptable and non-acceptable research