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"Or the other scenario Pasaca Capital Inc. uses QTMM to go public."
Not sure I know of any private venture capital firms that have gone public. They get to invest their capital as they see fit and they retain all their profits.
"indication that the Kansas suit has been settled?"
Maybe. I'm not sure how QMC could know how many shares or dollars they would need to close that chapter.
Its just a time limit on how long before Pasaca has to pony up if the $15 million guaranteed revenues are not achieved.
Example: If revenues are $15 million within one year, then there is no impact.
Example: If revenues are only $10 million after one year, then Pasaca advances QMC $5 million in royalties. Pasaca then retains all of their QD and/or app sales until they recoup the $5 million. Then future sales go to QMC.
We now know that a good portion of the operating expenses and new hire salaries over the last six months were being paid for by $3 million in loans from Pasaca.
$4.5 million of the $15 million equity investment is existing and new convertible debt with 8% interest and convertible at 2.9 cents. So Pasaca gets 15% of the company and "gets" that part of their equity investment back and makes money on the loan.
The other $10.5 million equity investment gets them the other 36% of the company at what I estimate to be 4.5 cents per share.
Half of the $15 million plus in future fees and royalties "belong" to Pasaca, so not $15 million potentially flowing to current QMC shareholders.
But half a pie is better than none.
With some minor updates.
(c) Capitalization. As of the date of this Agreement, the authorized capital stock of the Company consists of 750,000,000 shares of Common Stock, of which, as the date of this Agreement, 689,153,592 shares are issued and outstanding, 121,600,000 shares of Common Stock are reserved for issuance pursuant to the Company’s stock option, restricted stock and stock purchase plans, of which 121,600,000 shares are reserved for issuance pursuant to outstanding options and 64,049,738 shares of which are reserved for issuance pursuant to outstanding warrants exercisable or exchangeable for, or convertible into, shares of Common Stock, 124,246,699 common share are reserved for debt convertible into common shares and 8,980,202 are reserved for payment of services or purchase of digital assets. All of such outstanding or issuable shares have been, or upon issuance will be, validly issued and are, or upon issuance will be, fully paid and non-assessable. Except as set forth in the first sentence of this Section 3(c) or as disclosed in Schedule 3(c) of the Company Disclosure Schedule: (A) no shares of the capital stock of the Company are issued or outstanding; (B) no shares of the capital stock of the Company are subject to preemptive rights or any other similar rights or any Liens suffered or permitted by the Company; (C) there are no outstanding options, warrants, scrip, rights to subscribe to, calls or commitments of any character whatsoever relating to, or securities or rights convertible into or exchangeable or exercisable for, any shares of capital stock of the Company or any of its Subsidiaries, or contracts, commitments, understandings or arrangements by which the Company or any of its Subsidiaries is or may become bound to issue additional shares of capital stock of the Company or any of its Subsidiaries, or options, warrants, scrip, rights to subscribe to, calls or commitments of any character whatsoever relating to, or securities or rights convertible into or exercisable for, any shares of capital stock of the Company or any of its Subsidiaries; (D) there are no agreements or arrangements under which the Company or any of its Subsidiaries is obligated to register the sale of any of their securities under the 1933 Act (except the Registration Rights Agreement); (E) there are no outstanding securities or instruments of the Company or any of its Subsidiaries that contain any redemption or similar provisions, and there are no contracts, commitments, understandings or arrangements by which the Company or any of its Subsidiaries is or may become bound to redeem a security of the Company and no other stockholder or similar agreements to which the Company is party; (F) there are no outstanding securities or instruments containing anti-dilution or similar provisions that will or may be triggered by the issuance of the Securities; and (G) the Company does not have any stock appreciation rights or “phantom stock” plans or agreements or any similar plan or agreement. The Company has furnished to each Investor true and correct copies of the Company’s articles of incorporation, as amended and as in effect on the date hereof (the “Articles of Incorporation”), and the Company’s bylaws, as amended and as in effect on the date hereof (the “Bylaws”), the organizational documents and bylaws of each of the Company’s Subsidiaries, as amended and in effect on the date this representation is made and the terms of all outstanding securities convertible into, or exercisable or exchangeable for, Common Stock, and the material rights of the holders thereof in respect thereto.
Thanks had not got to the other 8-K.
Where's my coffee? and my snow shovel?
Jamis, where did you get the 51% and the 154 million share numbers?
The New York Times
The Morning
January 28, 2021
Author Headshot
By David Leonhardt
Good morning. Virus cases are falling more sharply in the U.S. than at any previous point.
A mass vaccination drive at Dodger Stadium in Los Angeles.Ryan Young for The New York Times
A 35 percent decline
The United States has never experienced a sharp and sustained decline in new coronavirus cases — until, perhaps, now.
Last year, new cases in the U.S. went through cycles of rising rapidly and then leveling off or falling only modestly. That was different from the situation in many other countries, where sharp drops sometimes occurred. Look at how much bigger the declines were in Western Europe last spring and last fall than in the U.S.:
By The New York Times | Sources: Governments and health agencies
But now the situation may be changing.
New cases in the U.S. have fallen 35 percent over the past three weeks. Hospitalizations have dropped, as well. Deaths have not, but they have stabilized — and the death trend typically lags the cases trend by a few weeks.
“I like the trends we are seeing, and I am personally hopeful that things are going to get better,” Jennifer Nuzzo, an epidemiologist at Johns Hopkins University, told me. “But there are a number of things that could also wrong.”
The good news
Let’s start with two possible explanations for the recent improvement:
1. We may be in the very early stages of herd immunity. Roughly 100 million Americans seem to have had the virus. (For every person who tests positive, three more have had it without being diagnosed, studies suggest.) Another 24 million people have received a vaccine shot.
Put those two groups together, and you realize that about one-third of all Americans have at least some degree of immunity from the virus. That may be enough to begin — begin — slowing the spread, as my colleague Donald G. McNeil Jr. explained on “The Daily.”
2. More Americans may be wearing masks and staying socially distant. Many still are not, as I saw on my recent 1,600-mile road trip. But any increase in safe behavior matters.
And there are signs of change. Multiple states tightened restrictions late last year. The country just elected a president who echoes scientific advice rather than flouting it. Some Americans may also be inspired by light at the end of the tunnel.
“I’m hearing from a lot of people that one of the reasons why they’re really hunkering down now is that it would be a shame to get a severe Covid case while waiting to get the vaccine,” Dr. Lee Harrison, the chairman of a local health board, told The Pittsburgh Post-Gazette this week.
Dr. Mark Escott, who runs the a local health agency around Austin, Texas, told the CBS affiliate there: “Folks are changing behavior. Folks are wearing masks, folks are staying home, and that is resulting in these decreasing cases.”
Dr. Alex Garza, a member of a pandemic task force in St. Louis, told The Associated Press: “The fact that this is happening in the winter when respiratory viruses typically spread the most shows us just how effective all the preventative measures actually are when we use them.”
It could get worse again
I want to emphasize that the pandemic has not entered an inexorable decline.
The biggest reason for concern is the newly infectious variants that could cause case numbers to surge again, especially if people become blasé about masks and distancing — or the Biden administration fails to accelerate vaccinations. And the current rate of death from Covid-19 remains horrific.
But the U.S. has it within its power to make this month a true turning point.
Abbott Continuing Focus on Rapid Testing in Light of COVID-19 Pandemic
Jan 27, 2021 | Kelsy Ketchum
Premium
NEW YORK – With the ongoing COVID-19 pandemic showing scant signs of slowing down, Abbott reiterated on Wednesday its commitment to the continued development and rollout of rapid tests for help mitigate the spread of SARS-CoV-2.
The ongoing COVID-19 pandemic has driven demand for scalable, accurate, and rapid testing, and despite the rollout of SARS-CoV-2 vaccines that demand will likely continue throughout the rest of the year. During Abbott's fourth quarter earnings call CEO Robert Ford drove home the importance of rapid testing to the firm's revenues and long-term strategies beyond COVID-19.
The company has seen significant revenue growth thanks to its COVID-19 testing portfolio, with total revenues increasing 29 percent year over year to $10.7 billion in Q4 2020 and diagnostics revenues up 111 percent to $4.35 billion from $2.10 billion last year. A huge component of that revenue was rapid diagnostics, with revenues of $2.41 billion, an increase of 334 percent from the year-ago quarter.
Ford added on the call that during the Q4 2020, the largest contribution in COVID-19 testing sales came from the company's rapid tests, including the BinaxNow, Panbio, and ID Now platforms. Of the $2.4 billion in COVID-19 sales, rapid tests made up $1.9 billion.
Ford said Abbott has also ramped up its manufacturing capacity, providing more than 100 million SARS-CoV-2 BinaxNow and Panbio COVID-19 rapid antigen tests combined per month. Despite this increase, he added there is still more room to increase production as Abbott hasn't utilized all of the manufacturing capacity it has built with much of that capacity built around rapid tests.
Abbott has been able to leverage the joint development of the BinaxNow and Panbio tests since they use the same lateral flow technology just in a different format, Ford said. The BinaxNow test is available in the US, while the Panbio test is available everywhere besides the US and has global supply chains. "The demand that we're seeing internationally I would characterize also as probably just starting, it hasn't even peaked either," he said.
Ford also emphasized the importance of thinking globally when considering COVID-19 demand. Because countries are facing different cycles of disease and vaccination strategies, with some in the throes of the pandemic and some getting back to business as usual, "this is not going to be something that will just be done in the next couple of quarters," Ford said.
One concern, that the antigen tests won't be able to detect new variants of the SARS-CoV-2 virus, such as those found in the United Kingdom and South Africa, hasn't been a problem for Abbott's tests, Ford said. Abbott's rapid antigen tests target the nucleocapsid protein, while the other variants seen globally have had mutations on the spike protein. Ford mentioned that Abbott is collecting samples and "constantly studying to ensure that there's no change in the sensitivity of the tests that we've developed."
The focus on rapid testing has sped up Abbott's long-term strategy to decentralize laboratory testing and open new testing channels, which started with the company's acquisition of Alere in 2017, Ford said. The pandemic has accelerated that strategy by about two years and has placed the emphasis on point-of-care testing. "Everything we're doing in fighting the virus has not only a direct impact of helping reopen the economy, etc., but it's also seeding the market and it's building these new testing channels," he added.
Although Abbott started developing COVID-19 tests for laboratory-based systems, such as the SARS-CoV-2 molecular test that runs on both the Alinity m and m2000 RealTime instruments, due to the existing placements of those instruments in labs, the firm "knew that in a pandemic you were going to need to add on top of that testing infrastructure," Ford said. "You would have to add faster testing and testing that could be done at a much significant scale and that was more affordable, which is why we developed those two lateral flow tests."
The testing channels being built, such as those in airports, retail settings, schools, and other congregate settings, aren't going to go away once demand for COVID-19 testing decreases, Ford said. And that demand likely won't decrease for a while, even while the vaccine is being rolled out across the globe. "Even if COVID testing starts to mature a little bit in 2022, we believe there's a significant portion that's still very sustainable," he said. PCR testing, which usually has longer turnaround times, might not be as in demand in a post-vaccine world, but "fast, easier, much more scalable tests, digital tests that are priced for more accessibility and affordability, I think that's the sustained kind of business we see here," Ford said.
In addition, Ford noted that the clinical utility of the firm's rapid tests is strong, and that they can reliably find people who are infectious and actively spreading the virus, rather than those who previously had the virus and still have some remnants of virus DNA in their systems. A study from the US Centers for Disease Control and Prevention released last week found the BinaxNow test is less sensitive than PCR but could be useful when PCR tests aren't available or when quicker turnaround times are needed.
Subsequent to the $2.4 billion in COVID-19 testing sales during the fourth quarter, Ford said he is expecting Q1 2021 sales to be "in the $2.5 billion range," culminating to about $6.5 billion to $7 billion for the full year.
Beyond COVID-19, Ford said Abbott is investing in expanding its rapid testing portfolio and taking advantage of the new channels to "increase the penetration with different assays," such as those for respiratory syncytial virus, Streptococcus, sexually transmitted diseases, and the recently 510(k)-cleared rapid concussion test. The firm is also developing a rapid test using whole blood to detect concussions at the point of care, which will likely require another year and a half to come to market but is a "great opportunity" and could be used in high schools, universities, and sports leagues across the US, Ford said.
https://www.360dx.com
"without needing to go to a laboratory." Yes we know that.
Look at the reported results:
You may want to look closer at the website you posted.
The 68 million tests performed are lab based tests and 62.5 million of the tests were PCR tests and 3 million were antibody tests.
Correct, a lateral flow serology/blood test that identifies antibodies, not antigens.
They got cash two weeks ago at $3. Share price is $4 today. Looks more like the first.
The offering was public, not private.
True, but "comparing" the accuracy of their new and improved antibody test to the accuracy of the old lateral flow antigen tests is kink of apples and oranges since the two types of tests have different purposes. Just being critical.
Not impressed by the author of the article. The BioCard is an antibody test. His comparison to the Innova antigen test is not too relevant.
The BioCard test does appear to be an improvement over the other lateral flow antibody tests.
https://covid19biocard.co.uk/
If you buy 1000 SGLB shares today, it will cost you $3600 ($3.60 x 1000).
If you buy 10,000 SGLBW warrants today, which could be converted into 1000 shares by 2/15/22, it will cost you $4000 ($0.40 x 10,000).
If on 2/15/22, SGLB is $12/share, the 1000 Sigma shares will be worth $12,000, a gain of $8400 ($12,000 - $3600).
The 10,000 warrants could be exercised at $4 per warrant ($40,000) but you would then have 1000 shares only worth $12,000, not a smart move. So the 10,000 warrants should be allowed to expire worthless, a loss of the original $4000.
If on 2/15/22, SGLB is $40/share, the 1000 Sigma shares will be worth $40,000, a gain of $36,400 ($40,000 - $3600).
The 10,000 warrants could be exercised at $4 per warrant ($40,000) but you would have 1000 shares worth $40,000 (why bother), and a loss of the original $4000.
If on 2/15/22, SGLB is $80/share, the 1000 Sigma shares will be worth $80,000, a gain of $76,400 ($80,000 - $3600).
The 10,000 warrants could be exercised at $4 per warrant ($40,000) and you would have 1000 shares worth $80,000, and a gain of $36,000 ($80,000 - $4000 - $40,000).
If on 2/15/22, SGLB is $160/share, the 1000 Sigma shares will be worth $160,000, a gain of $156,400.
The 10,000 warrants could be exercised at $4 per warrant ($40,000) and you would have 1000 shares worth $160,000, and a gain of $116,000.
"Thanks! If that is the case, another way of looking at it is that for full comparison, with regard to what it would take to buy one share, the warrants are worth 1/10 of the stated price. Actually, at .30+ cents per share, it is really the equivalent of a .03cent "option" to buy at $4, which is actually a fairly reasonable price right now. That really helps me understand what I have!"
I'm not following your logic and don't see how you get to a "3 cent "option" to buy at $4".
Each warrant currently costs 30 cents, which can be exercised for $4 per warrant and gets you 1/10 of a share of common stock.
Therefore, "what it would take to buy one share" is you have to buy 10 warrants at 30 cents each or $3 to have the "option" to buy one share.
To exercise the 10 warrants for one share will cost you another $40 ($4 per warrant times 10 warrants).
So you do not have "the equivalent of a 3 cent "option" to buy at $4".
You have a 30 cent "option" to buy 1/10 of a share at $4, or
you have a $3 "option" to buy one full share at $40.
Note: You can currently but 1 share of stock for $3.60 and the share does not expire in 13 months.
Train, you have to pay $4 to exercise each warrant. So you have to pay $40 to exercise 10 warrants to get one share of common stock.
Warrants - As I posted on 3/1/20:
The reality is that one warrant (CUSIP 826598112) could/can be exercised for $4 and the warrant holder would receive 1 common share of the old CUSIP 826598302 shares.
When they reverse split the old shares 1 for 10 (1 new CUSIP 826598500 share for 10 of the old CUSIP 826598302 shares), then the "value" of the 1 old shares became 0.1 of a new share.
So to get one new share, 10 warrants would have to be exercised at the old exercise price of $4 each.
This effectively increases the exercise price to $40 for one new share and decreases the number of new shares that could be issued to 141,000.
This would explain why the warrant price did not drop from 32 cents to 3.2 cents during Friday's trading session.
The company did not announce and implement a 1 for 10 split of the warrants with a new warrant CUSIP along with the common share split. They could in the future, but to me it would just be a unnecessary effort and expense.
All that would need to happen in the future is that the company's transfer agent would simply issue one share of common stock for every ten warrants that get exercised. You can't exercise the warrants without going through the transfer agent, that is one of their jobs.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=154098756
Terms don't look too bad.
1.5 million shares at $3. Looks like average share price over last 30 days.
No warrants offered with the shares.
Underwriter not getting usual 8% fee in cash, but 8% in warrants and 1% in cash. Warrants priced at 125% x $3 or $3.75.
Up to $88K for expenses is typical.
30 day option for underwriter to purchase additional 15% more shares.
Need some more details, but think this is why price holding fairly well.
The options are part of the Director's annual compensation.
Previous years the directors were granted common shares (at zero cost) in January, this year, its changed to options that will cost them $3.13 to exercise.
In December, QMC did pay the $312 in court costs/fees that they owed the district court in the School Board case. Only a year overdue.
The finger stick tests (blood sample) are antibody tests.
The antigen tests are typically swab tests.
There was an un-named office administrator previously listed. That seems to have been replaced by Robin Squires.
The new listing is the CTO in San Francisco.
Jay Williams is still listed as CTO in Austin.
FDA Encourages Off-Label Use of Authorized COVID-19 Tests for Asymptomatic Results
Dec 16, 2020 | Madeleine Johnson
NEW YORK – In a weekly call with developers of SARS-CoV-2 diagnostic tests, the US Food and Drug Administration strongly encouraged the off-label use of Emergency Use Authorized tests to detect for the virus in asymptomatic people. The agency also encouraged developers of fully at-home tests to consider ways that results can be reported to local public health departments.
On Wednesday Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at FDA's Center for Devices and Radiological Health, asserted that the agency is allowing antigen and molecular diagnostic tests to be used off-label in testing asymptomatic patients, as directed by a prescriber for prescription-use tests.
"That is completely legitimate to do, we are encouraging it, because we only have a small number of tests that are authorized for asymptomatic screening," Stenzel said on the call.
In particular, Stenzel said all of the EUA direct antigen tests can be used for this purpose.
Overall, "There are rare examples where we've seen asymptomatic data that is not sufficient for authorization and we make a very rare and unusual statement in the Instructions for Use," he said.
Stenzel noted however that the performance in this off-label setting is still unknown. "That should be understood by the prescribers," he said, and test results should be considered in the context of local incidence to help determine whether a confirmatory test is warranted.
That said, "We are encouraging more and more submissions for asymptomatic screening claims, and we welcome those, but in the interim we've made this very clear, and [the Centers for Medicaid and Medicare Services] and HHS have made this very clear as well, and removed any potential roadblocks at the federal level," Stenzel said.
Last month, FDA had updated its FAQ page to note that EUA tests can be used at the discretion of a healthcare provider.
The FAQ notes that SARS-CoV-2 molecular diagnostic tests have been authorized for use in individuals suspected of COVID-19 by their healthcare providers, and individuals suspected of COVID-19 infection or exposure can be symptomatic, pre-symptomatic, or asymptomatic. "Testing of any of these individuals is at the discretion of the healthcare provider ordering the test," it says. "Additionally, certain SARS-CoV-2 molecular diagnostic tests have been authorized with a screening claim for use in individuals without symptoms or other reasons to suspect COVID-19," the FAQ also says.
On Wednesday's call with developers, Stenzel also commented on the authorization of an over-the-counter fully at-home test from Ellume, and announced the at-home indication for the Abbott BinaxNow test.
The agency is "extremely excited" about these authorizations, and "We look forward to more and more home testing authorizations, not just for antigen and molecular tests, but also for serology tests," Stenzel said.
He also mentioned a recent prescription-use, at-home molecular test, referring to the Lucira COVID-19 All-in-One Test Kit from Lucira Health which received EUA last month.
"Of course, molecular is great if it can be done in the home environment. There is a challenge though in that it is more difficult to manufacture molecular tests in quite the same volume as direct antigen lateral flow tests," Stenzel said, adding that there may also be "cost differentials" between antigen and molecular testing.
Stenzel added that the manufacturing capacity for paper-strip antigen tests is in the tens of millions per month, if not in the hundreds of millions, from each manufacturer.
"There is a desire out there to have a lot more testing, there is a willingness to do this, so we're looking at how we can make that testing as widely available as possible, so that consumers and home users can get a fast, accurate result that they can use to make the very best decisions about their lives and those of their loved ones," Stenzel said.
In response to a question from a developer, Stenzel commented that reporting of test results to the appropriate public health agencies is "strongly encouraged," even for home tests without a corresponding app.
The Ellume test is paired with an app that enables reporting to a public health authority, while Abbott is partnering with eMed to allow reporting of test results in the BinaxNow home-use indication using its NAVICA app.
"It is obviously critical that the US government and public health authorities have data on where virus is going up and where virus is going down," Stenzel said. "The more we have that information in real time, the faster we can make assessments," he added.
"While it is not what I would call a decision requirement for an EUA, we encourage developers to think about this," he said.
Indeed, the first at-home test authorized, Lucira Health's test, did not have a reporting mechanism component, Stenzel said. "We asked them as part of the post-market commitment to come up with a plan to be able to provide home users ... or their prescribers to be able to report that information."
Stenzel also noted that a US government design competition, or "app-a-thon," recently concluded that aims to identify reporting technologies that could be used independent of specific tests.
"If a given small developer of a test doesn't really have the capability to think about this, then having an off-the-shelf app that could be used for them would be awesome," Stenzel said. "We are pushing that forward."
Winners of HHS Design-a-thon to Develop Innovative Digital Health Tools for COVID-19 At-Anywhere Diagnostic Tests Announced
Prizes went to best software and digital tools directly integrated with COVID-19 tests to automate and expedite data reporting.
Sixteen winning designs (listed below) selected from the HHS COVID-19 At-Anywhere Diagnostics Design-a-thon exit disclaimer icon aim to increase speed, quality, comprehensiveness, and utility of SARS-CoV-2 diagnostic test data. This effort will help maintain visibility and increase reporting accuracy on SARS-CoV-2 infection rates across the country. Another contest objective is to ensure that all SARS-CoV-2 diagnostic tools can securely transmit test results to local and national public health authorities, as well as health care providers and patients, ensuring a timely public health response.
...
https://www.hhs.gov/about/news/2020/12/16/winners-of-hhs-design-a-thon-to-develop-innovative-digital-health-tools-for-covid-19.html
With $1.2 million per quarter expenses, they need about $5,000,000 (7 figures) per year to break even
Enhancements?
Now they show two women entering an "office?" and having a thermal scan to determine their temperature, which appears to get manually recorded in the laptop. No scanning of their cell phones to establish their identity via QR code or scanning of QD embedded ID badge.
The illustrations below shows a forehead temperature scan, which is labelled "2 Employee taking rapid diagnostic test".
This is an upgrade by the new marketing department?
"Was it to apply for an S-1, which according to Ted ("The S-1 was drafted in 2016 by K&L for the Lincoln Park deal that Sri signed in Nov. 2016 and Steve chose to use that S-1 draft in 2017.") happen, thus fulfilling that obligation of the contract?"
No.
The initial S-1 is written and signed by the company, filed with the SEC via EDGAR, and then reviewed by the SEC. The SEC can request clarifications and changes from the company and when the SEC is satisfied, then the SEC issues a Notice of Effectiveness.
I did not say that the S-1 was "applied" for. The initial S-1 draft for the 2016 deal was not completed by QMC and was not filed before the 12/31/16 deadline.
So when QMC signed the L2/SBI deal in Mar 2017, which required the filing of an initial S-1, QMC elected to continue to use the existing draft, since they had already been charged a significant sum of money by K&L Gates for proving the draft document.
As described in Kansas trial, QMC tried to complete the S-1 in May, but their auditors (Weaver & Tidwell) would not approved it. Probably the same issues that prevented QMC from filing the 1st quarter 10-Q on time in May 2017. L2 granted QMC an extension for the S-1 filing, but QMC failed to meet the new June deadline and failed to request another extension.
Again, QMC failed to file the initial S-1 as required by the L2 contract and that was a claimed default.
£1M funding for the development of a quantitative lateral flow Smartphone Reader
Posted: September 17, 2020
Abingdon Health announces £1M Innovate UK funding for the development of a fully quantitative lateral flow Smartphone Reader AppDX, the lateral flow rapid test reader that received £1M development funding
Innovate UK has released £1M to fund a further next generation development of Abingdon Health’s lateral-flow rapid test readout technology; AppDx®. The project will see the enhancement of AppDx® at an accelerated pace to achieve a fully quantitative smartphone-based solution for the lateral flow assay (LFA) market.
https://www.gov.uk/government/organisations/innovate-uk
Part of UK Research and Innovation
https://www.gov.uk/government/organisations/uk-research-and-innovation
The L2/SBI contracts in March 2017 where reviewed by Steve, the BOD and Morse (QMC's security/SEC council) per Steve's testimony during the Kansas trial. Could not afford additional council.
QMC's claim was that a number of the documents were drafted by K&L Gates for earlier deals in 2016 and were reused by QMC in 2017.
The S-1 was drafted in 2016 by K&L for the Lincoln Park deal that Sri signed in Nov. 2016 and Steve chose to use that S-1 draft in 2017.
Nothing specific, just recalling some of the other court filings that discussed needing to meet certain dollar values.
I don't think that the original $100,000 in damages was a calculated number based on actual damages determined at the time of bringing the suit, but a place holder. Different courts have different thresholds for damages.
By claiming $100,000 or greater in damages and 1000 times for punitive damage, the suit was put into the top category. That was enough to move the suit forward.
Covid-19: Innova lateral flow test is not fit for “test and release” strategy, say experts
BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4469 (Published 17 November 2020)
Covid-19: Concerns persist about purpose, ethics, and effect of rapid testing in Liverpool
BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4690 (Published 02 December 2020)
Covid-19: Safety of lateral flow tests questioned after they are found to miss half of cases
BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4744 (Published 04 December 2020)
The Nov 30 UK Government Policy Paper (Community testing: a guide for local delivery)
https://www.gov.uk/government/publications/community-testing-explainer/community-testing-a-guide-for-local-delivery#what-the-community-testing-programme-is
https://cen.acs.org/biological-chemistry/infectious-disease/UKs-ambitious-Operation-Moonshot-screening/98/i48
Can the UK’s ambitious Operation Moonshot screening program for COVID-19 achieve liftoff?
Researchers question accuracy of rapid antigen tests and criticize government’s lack of transparency in multibillion-pound program
by Mark Peplow, special to C&EN
DECEMBER 4, 2020 | APPEARED IN VOLUME 98, ISSUE 48
Matt Hancock’s optimism was running at full throttle as he addressed lawmakers in the UK’s House of Commons Sept. 10. Hancock, the government’s secretary of state for health and social care, waxed lyrical about a new wave of “simple, quick, and scalable” COVID-19 diagnostic tests that could be rolled out for routine screening in workplaces, schools, theaters, and sports venues as part of an ambitious plan to control the pandemic. “So-called Operation Moonshot, to deploy mass testing, will allow people to lead more normal lives and reduce the need for social distancing,” he promised.
Some epidemiologists have been advocating for this kind of routine COVID-19 screening since the early days of the pandemic. Conventional diagnostic testing typically targets those with disease symptoms and their close contacts, potentially missing the huge numbers of people who are presymptomatic or asymptomatic yet still infectious. In contrast, mass screening ensures that everyone in a particular location is tested regularly, whether or not they have symptoms, so that infected individuals can quarantine. This strategy has shown promise in keeping open some universities and workplaces, and the UK’s Operation Moonshot aims to extend this idea nationwide, potentially making it one of the largest such screening efforts in the world.
But the government’s moonshot is having a troubled launch.
There is controversy around some of the tests used in the program, including the Innova SARS-CoV-2 Antigen Rapid Qualitative Test, which detects SARS-CoV-2 antigen proteins from a nose or throat swab. The lateral-flow device takes about 20 min to signal a positive result as a colored band on a cellulose strip, similar to the readout from a home pregnancy test. The government’s evaluation of the test found that, in some community testing centers, it missed almost half the positive cases identified by reverse transcriptase polymerase chain reaction (RT-PCR) , the gold-standard diagnostic for COVID-19.
None of these tests are tests of infectiousness, and that’s one of the myths that is being propagated.
Allyson M. Pollock, public health researcher, Newcastle University
At a press conference Nov. 16, public health researchers expressed concerns about the spotty results, the vast sums of public money being poured into the program, and the UK government’s lack of transparency about how it selected the screening tests. They also pointed out that the government had not consulted the country’s advisory body for health screening before the program’s launch. “The Moonshot program really should be paused until the cost effectiveness and the value for money,” of the various efforts underway is well established, Allyson M. Pollock, a public health researcher at Newcastle University, said at the press conference.
Despite these concerns, the government has spent billions of pounds on procuring tests for Operation Moonshot, and estimates provided to the government suggest the program may eventually cost more than £100 billion ($133 billion)—about three-quarters of the government’s entire health budget in normal times.
Countdown to liftoff
The government laid the groundwork for Operation Moonshot in August, when it tasked researchers at Public Health England—an executive agency of Hancock’s department—and the University of Oxford with evaluating a range of antigen tests. According to documents subsequently leaked to the British Medical Journal, the products the researchers selected could help screen about 6 million to 10 million people each day by early 2021. People who tested negative would receive an app-based immunity passport, allowing them to socialize more freely.
But researchers still have many questions about the selection process because so few results have been published. “That lack of transparency has been a criticism from the beginning,” says Joe Fitchett, medical director at Mologic, a diagnostics manufacturer whose antigen test was evaluated by the government and Oxford researchers. Indeed, the Good Law Project, a nonprofit, is suing the government for not disclosing how it awarded testing contracts.
On Nov. 6, the UK’s first citywide screening trial began in Liverpool, England, which had a relatively high infection rate of 300 cases per 100,000 people. The Liverpool Mass Asymptomatic Serial Testing (MAST) trial aimed to reach up to half a million people—the city’s entire population—and relied mainly on the Innova test. Yet when the trial began, the government had not published any data about the effectiveness of the test or any protocol for the trial.
During the 3-week trial, thousands of military personnel administered the test at dozens of centers, and citizens were encouraged to take a test every 5 days, via nose and throat swabs, with results returned in less than 2 h by text or email. Anyone testing positive had their diagnosis confirmed or rejected by conventional RT-PCR.
Yet validation data on the Innova test emerged only Nov. 10, during a hastily arranged webinar hosted by the British Infection Association and the Royal College of Pathologists; the University of Oxford published its full evaluation report the next day.
It showed that the test had a specificity of 99.68%, meaning it produced very few false-positive results. However, its sensitivity, or how well it detects positive samples, was poorer: in the hands of researchers or trained nurses, the device caught 77% of all positive samples, but for self-trained individuals at community testing sites, that proportion dropped to 58%. “So there’s a difference in the overall antigen detection rate in different settings, which at the moment we think is caused by the degree of training,” Timothy E. A. Peto of the University of Oxford said during the webinar.
The performance of the Innova test also depended highly on the amount of virus present in the sample. In spiked samples containing roughly 100,000 RNA copies per milliliter, the test identified 95.5% of the positives; with only 20,000 RNA copies per milliliter, it identified none. “This test, and many similar tests, will miss cases when viral loads are lower,” says medical statistician Jonathan J. Deeks at the University of Birmingham.
Innova argues that this limit of detection is a feature, not a bug. “The objective of this test is to determine whether someone is infectious,” says Peter Santeusanio, vice president of product management at Innova Medical Group in California. The validation data show that the device returned a positive result for almost every sample with an above-average viral load, and Santeusanio argues this would identify people who pose the greatest risk of transmitting COVID-19. In contrast, those with the lowest viral loads—who are presumably less infectious—would get a negative result and avoid quarantine. If the test missed a presymptomatic individual whose viral load was on the rise, a subsequent test would catch the infection a few days later.
But Deeks and Pollock say there is little direct evidence that viral load is proportional to infectiousness in this way. “None of these tests are tests of infectiousness, and that’s one of the myths that is being propagated” by the UK government, Pollock says.
However, Daniel B. Larremore, an infectious disease modeler at the University of Colorado Boulder, believes the Innova test could help control infections. He and his colleagues have modeled the effectiveness of a rapid antigen test operating at a similar limit of detection and sensitivity as the Innova test; they found that the frequency of testing and how quickly the results are reported are far more important than sensitivity to ensure a successful screening program (Sci. Adv. 2020, DOI: 10.1126/sciadv.abd5393).
Their model simulated a population of 10,000 people and predicted how well an outbreak could be controlled by isolating positive cases after screening with one of two tests: a rapid antigen test that could detect viral loads equivalent to 100,000 RNA copies per milliliter and an RT-PCR test that can typically detect around 1,000 viral RNA copies per milliliter.
Although the antigen test was less sensitive than RT-PCR, it delivered results almost instantly, while RT-PCR took up to 2 days to process. The model predicted that giving people the antigen test every 3 days would reduce the overall infectiousness of the population by about 80%. “This repeated testing catches all those little embers that could start local fires but instead get extinguished quickly,” Larremore says. In contrast, an RT-PCR test offered at the same frequency would reduce infectiousness by only about 50%.
“There’s been a big discussion among scientists about the validity of asymptomatic testing,” says Deenan Pillay, a virologist at University College London. “Personally, I support more aggressive screening, especially with younger populations, where a greater proportion of people are going to be asymptomatic.”
Onward and upward
While the scientific debate raged through November, the MAST pilot in Liverpool deployed more than 100,000 Innova tests, which identified about 1,000 positive cases. No results have been formally published, but preliminary data was buried in an appendix to the government’s new mass screening guidelines, which were released on Nov. 30. The report says Innova’s antigen test picked up just 5 of the 10 infections detected by PCR and “more than seven out of 10 cases with higher viral loads, who are likely to be the most infectious. ”Nevertheless, Hancock has hailed MAST as a success and credits it with helping reduce the infection rate in the city to about 100 per 100,000; however, the region also implemented strict social-contact restrictions that would have significantly curbed infections anyway. So far, Innova has shipped 120 million–140 million tests to the UK, where they are being rolled out to 67 more towns and cities. The company is bidding for a new UK government contract, valued at £912 million.
Operation Moonshot is also introducing twice-weekly testing for roughly 1 million National Health Service staff, nursing-home workers, and other high-risk groups. But in early December, some local councils in the region asked nursing homes to hold off on using Innova tests, in part because staff had not yet been trained. Some healthcare workers will be tested with a different assay, made by OptiGene, which relies on loop-mediated isothermal amplification (LAMP) technology to detect viral RNA. In one study, which has not been peer-reviewed, the test showed a sensitivity of 97% and a specificity of 99% (medRxiv 2020, DOI: 10.1101/2020.06.30.20142935). But it too has come under fire: a pilot of the assay in Greater Manchester in September and October suggested it has a much lower sensitivity, according to scientists in the region’s mass-testing expert group.
The overarching goal of Operation Moonshot is to ramp up COVID-19 screening to levels seen in countries like China and Slovakia. After a strict lockdown, China used mass screening of millions of people in several cities, including Qingdao and Wuhan, to quash any budding outbreaks. Those efforts have generally relied on RT-PCR and other technologies to increase throughput.
Slovakia, meanwhile, embarked on a population-wide screening effort on two successive weekends in November. Most of the testing relied on SD Biosensor’s Standard Q antigen test, which was the first rapid point-of-care COVID-19 test to receive World Health Organization approval.
Roughly 1% of people tested positive by nasal swab in the first weekend, which covered nearly two-thirds of the country’s population, and they were required to quarantine. In a preprint, which has not yet been peer reviewed, researchers revealed that the screening program had played a key role in reducing the prevalence of infection in the country by 82%, and declared it “highly successful. ”Many researchers are skeptical about the UK government’s ability to pull off such an ambitious program. Beyond the limitations of the tests themselves, the pilot program in Liverpool suggests uptake could be an issue—in low-income areas of Liverpool, participation was as low as 4%. Critics argue the government should instead focus resources on improving the UK’s £22 billion COVID-19 testing and contact-tracing service for symptomatic people. In November, the National Health Service Test and Trace service reached only about 60% of close contacts of infected individuals. “Focusing on testing without a bigger focus on contact tracing and isolation is a bit of a waste of effort,” Pillay says.
Meanwhile, a series of COVID-19 vaccine trials has reported successes, and widespread vaccination is expected to begin in many countries early next year. So just as the UK’s mass-screening program takes off, might vaccines render it redundant? Larremore thinks not: “There’s a big role for increased testing in the time between now and next summer,” he says. “Just as I don’t think we’re going to take the masks off for another 6 months, I also don’t think we’re going to sidestep the need for testing in that time.”
Mark Peplow is a freelance science writer based in the UK.
Yes £600M or $800M is a a lot of money.
But some people complained that the $138M contact was being under valued since they believed the contact was for £138M and not the £104M, which is the equivalent of the $138M.
The "under valuing" of the supposed £138M contact to £104M was only by a factor5 of 25% and the "under valuing" of the two contacts combined (£634M to £600M) was only by a factor of about 5%.
But now the two contacts are being double counted and "over valued" from £600M to £1,234M, or by a factor of more than 100%.
Why the need to grossly over state the value of the Innova contracts?