Genome Engineering
Grand Scale Genome Engineering of Viruses, Bacteria, and Eukaryotes
Q1. The product which I want to bring to market to make a difference is as follows:
- My product is a 20-minute serological test which tests the presence of IgM and IgG antibodies to SARS-CoV-2, which will be present in blood up to 10-11 days from infection.
- It is based on a lateral-flow immunoassay which initially can be undertaken only in a lab, but has potential for home use.
- The test uses a fingerpick of blood and a small strip of special conjugate pad – the whole test equipment is contained in a single use plastic covering.
- The sample of blood is placed in a well and migrates with capillary action along a conjugate pad containing colloidal gold nano-particles which have SARS-CoV-2 recombinant antigens.
- If the sample contains the antibodies then it attaches to the gold nano-particles and forms a distinctive visual pattern which can be read on a scale.
Q2. The approval process of my device under the current pandemic scenario is as follows:
- On February 4, a public health emergency was announced which justifies the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of Covid-19, known as Emergency Use Authorizations (EUAs).
- Procedure was outlined on FDA Policy for Diagnostic Tests for Coronavirus Disease-2019 on March 16.
- The CDRH Website listing EUAs already has lateral-flow immunoassay tests for Covid-19 so my product should be a comparative device.
- There is a 15-page Word Document form “Test Kit Manufacturer: EUA Template” which can be completed
- The FDA is interested in early interactions with test developers and will review data on a rolling basis – encourages to reach out early before paperwork
- No mention of time to approve or costs
Q3. The non-urgent approval process for a med device in the United States is summarized as:
- An approval for a lateral-flow immunoassay test would be classified by the US FDA Center for Devices and Radiological Health (CDRH).
- There are comparative devices and so importantly there would be an existing product code – a much easier process than an entirely new device which can take 2 to 3 years of clinical trials and costs between $10 million and $20 million.
- A Lateral-flow immunoassay would also be a Class II or “moderate risk” and so PMN (501k) clearance, - a fast-track process for devices with substantive equivalence to existing device.
- PMN must be submitted to the FDA at least 90 days prior to anticipated marketing along with a fee of ($5,228) – at which point the FDA may determine predicate does not qualify or otherwise provide a confirmation that a review process has begun.
- In the first 15 days an acceptance reviewer will confirm passing to a lead reviewer who may likely need questions answering but will provide an acceptance within a further 45 days.
- Once FDA approval is given, the sponsor must register the business that will produce and distribute the device within the United States and “list” their device.
- JACC: Basic to Translational Science, Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices,2016 Van Norman, G