It's Wednesday, finally. DECN was given ample opportunity to be specific and transparent about the state and accuracy of the test, any to my surprise, they mostly were. Here's a handy scorecard to use to see what goalposts keep getting moved and where all the holes that need to be filled are:
Everyone get nice & familiar with:
http://www.pharmatechsolutions.co/assets/inse...ro!_PP.pdf
Timing matters here. Let's see:
Watch that space.
March 16:
https://www.accesswire.com/580769/DECN-Update...d-to-480mm
The test is not complete. Additionally, "all other requests" should have been met by now?
Finally, on the 18th, according to DECN, H5N1 was "validated", "most recently the methodologically similar corona virus" is a sentence fragment and doesn't mean anything.
So where are the results?
Who has The Link for the summary of test results? It's not proprietary or sensitive information... it's going to be on the website and in every box.
Except it isn't. The FDA has approved half a dozen rapid tests just in the past few days, with scores more on the horizon. DECN hasn't even registered for the race yet.
What DECN has is "specs," "guidelines," "methods," "proposals"... watch all the Weasel Words down below..
I have no idea WTH a Pre-UEA is. Here is the Pre-EUA description:
https://www.fda.gov/emergency-preparedness-an...ostics-fda
Anyone can file a Pre-EUA. You can file a pre-EUA. I can file a pre-EUA. The only thing that matters, is the FDA **GRANTING** an EUA.
Nothing.
Now here's the real kicker... and I know it will come as a shock to many, but both tests require antibodies. Nobody here understands this. And glaringly absent from all of DECN's discussion of these tests is how they plan to get them. This isn't simply chemistry, it's biology as well, and it's way outside of DECN's league. We have not heard "we have a working test for Covid19 and here is a summary of the results" because without those components, they don't have a test. They've given themselves 8 weeks to pull a Hail Mary, but even that is probably too short of a runway. In the meantime:
Abbott - 5 min test, making 50,000 a day:
https://www.forbes.com/sites/brucejapsen/2020...83f8106086
Bodysphere - 2 min test (this is what it looks like when you have a real, functional test):
https://www.reuters.com/article/us-health-cor...SKBN21I1T7
Qiagen 1 hour, but holy s***, the kitchen sink:
https://www.genomeweb.com/pcr/qiagen-receives...oS0KepKiUk
Good lord. That's what a Winner looks like, ladies and gentlemen.
Oh, and not greenlighted YET, but going to kick a** when it does...
Mologic - ***$1*** "pregnancy test (no meter)" style, 10 minute test!:
So let's see those results, DECN. Post 'em up on the website, like the FDA requires you to. Somebody won't be getting their EUA until they do!
Everyone get nice & familiar with:
http://www.pharmatechsolutions.co/assets/inse...ro!_PP.pdf
Timing matters here. Let's see:
Quote:
First: "ready in the summer of 2020"
But then: "Our plan is designed to bring at least 100,000 of our kits to market in the USA and Canada, and another 100,000 in Europe, during the month of May 2020."
Next: " late summer of 2020"
Now: "September 2020"
Watch that space.
Quote:
As this Coronavirus spread, and with time on their hands during the lock down, we asked The Bio several
days after their mid-February 2020 lock down , to look into whether some of our diabetic detection and management
technologies could be put to use to develop a coronavirus test.
March 16:
https://www.accesswire.com/580769/DECN-Update...d-to-480mm
Quote:
We are awaiting release of blood samples from previously infected people in Daegu, Korea, so that we can complete testing and make a final report to the U.S. FDA so that we may secure our Emergency Waiver. In the meantime, all other requests made by the FDA will be met this week and next.
The test is not complete. Additionally, "all other requests" should have been met by now?
Finally, on the 18th, according to DECN, H5N1 was "validated", "most recently the methodologically similar corona virus" is a sentence fragment and doesn't mean anything.
Quote:
GenViro!™ has been validated at the company's R&D center in Daegu, Korea for the H5N1 virus and most recently the methodologically similar corona virus.
So where are the results?
Quote:
A significant change to this policy is that once validation testing for a product has been completed, the test can be distributed to customers, entities and users, with certain labeling and a summary of test results provided on the company website (and/or the package).
Who has The Link for the summary of test results? It's not proprietary or sensitive information... it's going to be on the website and in every box.
Quote:
Keith Berman, CEO of DECN commented, "We have the technology perfected which will take months off of the development schedule. Our impedance powered diagnostic will be field tested at ground-zero in Daegu, Korea, where 700+ people have already been overcome by Coronavirus (COVID19) and where all of the clinical studies for our "Gen" products were tested. Our timing here is spot-on."
Except it isn't. The FDA has approved half a dozen rapid tests just in the past few days, with scores more on the horizon. DECN hasn't even registered for the race yet.
What DECN has is "specs," "guidelines," "methods," "proposals"... watch all the Weasel Words down below..
Quote:
The specifications guidelines set down by Mr. Berman, for creating this Covid-19 testing device and its
important chemistry, were that the test must be measured on the company’s existing Precise or Avantage glucometers,
because they were completed products, having been tested to great length, and now to be adapted for detection of
Covid-19 instead of whole blood glucose . [what happened to H5N1??] In addition, the resulting chemistry would necessarily run using a patients
(small sample of) whole blood taken from a finger prick, and later defined as 1-2 microliters (a small drop on a finger
tip), and perform the test and provide a result in one minute or less (later redefined as 15 seconds or less), with at least
a 95% accuracy. Mr. Berman believed this device was capable of 97-98% accuracy.
"our screening method should allow for 80% of the suspected carriers of Coronavirus to exit the quarantine systems"
The design above is in many regards similar to the direct antibody antigen approaches favored by some of
the competitive companies in the Covid-19 testing field. But the major difference (magic) is that the approach used
by the company in its GenViro! product allows for swift (15 seconds or less) results using a minimum of blood from
a finger prick. As of this writing, work has commenced on the product specification above with components such as
the platinum electrodes, platinum carbon paste, industrial films (several types) to make the biosensor, and perhaps a
new impedance chip for the meter.
The most immediate request made to the FDA will be for Pre-UEA, the new accepted standard for emergency diagnostic products
I have no idea WTH a Pre-UEA is. Here is the Pre-EUA description:
https://www.fda.gov/emergency-preparedness-an...ostics-fda
Anyone can file a Pre-EUA. You can file a pre-EUA. I can file a pre-EUA. The only thing that matters, is the FDA **GRANTING** an EUA.
Quote:
Our biggest challenge will be meeting the expected crushing demand. For that we prepared, and are interviewing most likely partners currently."
We will discuss partnering potential in a coming release.
Nothing.
Now here's the real kicker... and I know it will come as a shock to many, but both tests require antibodies. Nobody here understands this. And glaringly absent from all of DECN's discussion of these tests is how they plan to get them. This isn't simply chemistry, it's biology as well, and it's way outside of DECN's league. We have not heard "we have a working test for Covid19 and here is a summary of the results" because without those components, they don't have a test. They've given themselves 8 weeks to pull a Hail Mary, but even that is probably too short of a runway. In the meantime:
Abbott - 5 min test, making 50,000 a day:
https://www.forbes.com/sites/brucejapsen/2020...83f8106086
Bodysphere - 2 min test (this is what it looks like when you have a real, functional test):
Quote:
The Los Angeles-based company’s two-minute testing kit uses antibodies in blood to test for current or past infection with a 91% clinical specificity rate and a 99% clinical sensitivity rate, according to a news release. The test delivers results on-site in as fast as two minutes.
Bodysphere said it has contracted cargo planes to deliver the product to the front lines and touted its capability of having millions of test kits reach those front lines within weeks.
https://www.reuters.com/article/us-health-cor...SKBN21I1T7
Qiagen 1 hour, but holy s***, the kitchen sink:
Quote:
The panel can detect and differentiate SARS-CoV-2 and 20 other viral and bacterial pathogens known to cause serious respiratory disease from nasopharyngeal swabs in symptomatic patients, and will become the first "syndromic" testing product to be deployed in the US.
Specifically, the QIAstat-Dx panel is intended for the detection and differentiation of nucleic acid from SARS-CoV-2 as well as adenovirus; four other coronavirus types; human metapneumovirus A+B; influenzas A, A H1, A H3, A H1N1/pdm09, and B types; parainfluenza viruses 1-4; rhinovirus/enterovirus, respiratory syncytial virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.... and a partriiiiiiidge in a peeeeaaaarrrrr.... treeeeeeeeeeeeee
https://www.genomeweb.com/pcr/qiagen-receives...oS0KepKiUk
Good lord. That's what a Winner looks like, ladies and gentlemen.
Oh, and not greenlighted YET, but going to kick a** when it does...
Mologic - ***$1*** "pregnancy test (no meter)" style, 10 minute test!:
Quote:
Once ready, the device will allow users to test for exposure to the virus at home, in the community, or in the clinic, providing a result within 10 minutes, without the need for special training, electricity or a laboratory. The company is working in close partnership with the Institut Pasteur de Dakar to validate the COVID-19 test and manufacture at diaTROPiX, a new facility in Senegal. This will be the first time that a diagnostic kit created in the UK will be jointly manufactured in Africa, ensuring tests are available in settings with limited access to laboratory facilities.
Mologic has taken the decision to sell the diagnostic test at cost to low-income settings to ensure affected countries have access to the kits during the global emergency. This will allow high-quality diagnostics to be produced in low-income settings with the aim of ensuring that the test is available to all.
So let's see those results, DECN. Post 'em up on the website, like the FDA requires you to. Somebody won't be getting their EUA until they do!
