The average Joe/Jane/Jaswinder/Jaehee has never had to really contend with knowing the intricacies of Lab-developed tests (LDTs), CLIA waivers, FDA approved ones and all the different ways a test is developed. Now daily news about some new Covid-19 test or another and crackdowns on fake vaccines and tests have created a confusing scenario. Add to that, companies that first announced the availability of at-home tests only to be forced to pause their plans to launch them once FDA warned that it hasn’t approved any at-homes Covid-19 tests.
As a result, one company is taking an interesting stance toward testing. Southwest Regional PCR Laboratory doing business as MicroGen DX is a laboratory that is CLIA-certified and therefore doesn’t need approval from the FDA to run a saliva test for Covid-19, which it has developed. The company claims that it is the first national laboratory to offer a validated Covid-19 test using saliva and sputum samples. But given the climate of confusion surrounding tests, it decided to ask the FDA for a EUA (emergency use authorization) for its PCR diagnostic assay despite not needing it.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
On March 30, Chelsie Geyer, a microbiologist with the Office of In Vitro Diagnostics and Radiological Health from the FDA, sent a letter to the company saying “…EUA is not required for your assay at this time.”
Geyer made this determination based on FDA’s understanding that the MicroGencDX uses the “same primers/probes, positive/negative/extraction controls, and the same approach to interpretation as the CDC assay.”
MicroGenDX runs its Covid-19 Rapid PCR Test at its diagnostic laboratory in Lubbock Texas with a 24-hour turnaround from the time it receives a sample, according to a news release from the company. It has the ability to test 5,000 Covid-19 samples a day and hopes to be able to increase that to 10,000 per day in the future.
A spokeswoman for MicroGen DX confirmed that the company has completed actions suggested by the FDA that include performing a “bridging study to demonstrate similar LoDs when the assay is run with your modifications vs. according to the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel.” [LoD is short for “limit of detection” which refers to the smallest amount or concentration of analyte in the test sample that can be reliably distinguished from zero.]
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
FDA has gone on to list the MicroGen DX among the labs that are currently offering validated Covid-19 tests (See Q3 on this page).
Despite the FDA’s support, the spokeswoman said that MicroGen Dx is still pursuing the Emergency Use Authorization.
“Currently, the lab is still seeking a formal EUA letter in an effort to thwart all confusion created by at-home test kits in particular in the recent weeks,” wrote Ashley Moore, in an email.
Source: FDA, Flickr
