A new mRNA diagnostic tool developed at Stanford University and funded by
BARDA and DARPA is bringing implantable biochip technology closer to
reality.
by Raul Diego
October 08th, 2020
By Raul Diego
The POC (point-of-care) diagnostics market stands at about $18.8 billion
globally, according to recent market trends, and is expected to grow by a
third to $24.1 billion this year and projected to explode by 2024 to $46.7
billion. The main driver for these highly optimistic forecasts is the surge
in healthcare technology demand brought on by the pandemic crisis, which is
lining the pockets of big pharma and big tech, aided and abetted by the
Defense Department's various tentacles into the private sector, like DARPA
or In-Q-Tel, where federal dollars are channeled into private enterprise
through direct investment, stock purchasing, and grants, representing one of
the clearest examples of how the military industrial complex works.
The "detection" of COVID-19 is among the most crowded segments of the POC
diagnostics market and recent advances in the life sciences have made new
technologies, such as mRNA-based vaccines and testing possible. The U.S.
government, through the Department of Health and Human Services (HHS), has
been intimately involved in helping these technologies along, and in the
case of mRNA, specifically, has made considerable investments in its
development dating back to November 2019 in the case of one company
developing an mRNA-based COVID-19 diagnostic tool.
But in a paper published on the FDA's website, independent journalist Jon
Rappaport discovered that the CDC - at least in the summer of 2020 - had no
virus isolates of the novel coronavirus "currently available" and reveals
that all the assays used to design diagnostic testing algorithms for
COVID-19 were of other isolates meant to "mimic clinical specimen."
In other words, the tests aren't designed to detect COVID-19 at all, which
raises a number of questions, including why the Defense Advanced Research
Agency (DARPA) just awarded $1.1 million to a molecular diagnostic firm that
is working on a machine-learning diagnostic test for COVID-19, that uses
mRNA biomarkers to read the immune system's response.
A DARPA-Funded Implantable Biochip to Detect COVID-19 Could Hit Markets by
2021
An experimental new vaccine claims to be able to change human DNA and could
be deployed against COVID-19 by 2021 through a biochip implant.
MintPress News | Raul Diego | Sep 18
Verified COVID
The company's "host-response diagnostics technology," or HostDx, was
initially hypothesized by Inflammatix's co-founder, Timothy E. Sweeney,
during his time at Stanford University's Khatri Lab, which focuses on
developments in machine learning applied to biomedical research. Founded in
2016, the young company was incubated by the University's now-defunct StartX
fund and is run by four Stanford University alumni.
The Stanford University "spinout" company named its COVID detection product
CoVerityTM, which is billed as a way to help doctors make better decisions
for COVID-19 patients upon arrival at hospital emergency rooms, through its
mRNA rapid detection technology. Originally geared towards creating a more
accurate and faster diagnosis method for detecting sepsis, which Sweeney
calls one of the "holy grails of medicine," Inflammatix's core technology
was expanded to include influenza testing with host-response biomarkers in
November 2019, when it received a cost-sharing contract from the Biomedical
Advanced Research and Development Authority (BARDA) worth up $72 million.
BARDA's contract was followed up by $32 million in private venture capital
funds, and in March 2020, a full week before the World Health Organization
declared a global coronavirus pandemic, Inflammatix co-founders Sweeney and
Purvesh Khatri - principal investigator for Khatri Lab - published a study
in Nature Communications announcing "Improved identification of bacterial
and viral infections through a "29-mRNA neural-network classifier." The
study cited "recent advances in machine learning and artificial
intelligence" that can help distinguish "between bacterial, viral, and
non-infectious inflammation."
Another study published in April focused on the cost-effectiveness of the
"Novel Multi-mRNA Host Response Assay for Diagnosis and Risk Assessment of
Acute Respiratory Tract Infections," which concluded that Inflammatix's
HostDx technology provided "substantial cost savings." Among the lead
researchers for the study was Inflammatix COO Jonathan Romanowsky, whose
Linked-In profile describes him as an "expert in commercializing novel
molecular diagnostics."
The patently commercial feel of this endeavor is buttressed by the company's
origins in the Stanford' start-up incubator, which was sued by another
Stanford researcher and StartX fund beneficiary for using the fund "as a
mask by using non-profit employees and resources to run a venture capital
enterprise." While the University denies any wrongdoing, StartX was quietly
closed in 2019 as litigation in that case continues.
Proprietary singularity
The technology being developed by Inflammatix to predict the risk of severe
respiratory failure in patients with COVID-19 links directly to an
implantable biochip, also developed with DARPA money and covered by this
author, by virtue of its reliance on mRNA markers and health surveillance
data sets to execute its algorithm.
CoVerity requires the kind of technology made possible by DARPA's hydrogel
paired with a light sensor technology, like that provided by Profusa, Inc.
for DARPA's biochip, which can deliver binary signals for the algorithm to
process and make the diagnosis. Related technology has also been developed
by one of Inflammatix's board members, Steve Tablak, whose company GeneWeave
BioSciences was acquired by Roche in 2015 for its "Smarticles technology,"
which binds to family-specific DNA sequences of pathogens to produce a
"luciferase reporter" or binary light emission that can be read by
technology such as CoVerity.
Inflammatix CEO Timothy Seeney is confident that his algorithm is the best
"method for test development that involves analyzing raw data [to] discover
the best gene sets for specific applications." Investors, apparently, agree
and is the reason why the start-up decided to bring in onetime Roche exec,
Oliver Liesenfeld, as the company's Chief Medical Officer (CMO) to oversee
the product's clinical trials and the road to regulatory approvals as it
looks for FDA approval by early 2021.
Trump Pushes CDC To Release COVID Vaccine Before Election, Experts Say It's
Too Early
The CDC wants $6 Billion dollars to kickstart a mass COVID-19 vaccination
effort that CDC director Robert Redfield said is coming straight from the
top, but experts warn the efforts need more time and will pose a public
health challenge, claiming they could "be even worse than the problems with
testing and PPE."
MintPress News | Raul Diego | Sep 24
Just like Wall Street
If you ask MedWhat's CEO Arturo Devesa, the Stanford University Medical
School researcher who sued his alma mater's start-up accelerator StartX for
fraud, the experience "has made him question everything he believed about
Stanford's high-minded pursuit of innovation and Silicon Valley's promise of
meritocracy."
"I was really naive, and now I just see it for what it is," Devesa told a
San Jose news outlet in a 2019 interview. "It is not this amazing
entrepreneur-friendly thing that everybody talks about," he continued. "it's
just business. It's like Wall Street."
Given Stanford's deep ties to U.S. military intelligence dating back to the
cold war, through an early version of StartX called the Stanford Research
Institute (SRI), Devesa's assessment might reveal more about the true nature
of Wall Street as an arm of the U.S. military industrial complex, which
seems poised to make a killing on the brave new world of implantable
biochips and AI-enabled diagnostic tools that are on the brink
revolutionizing the healthcare industry.
