NONPROFIT, NONPARTISAN PLATFORM OF ACCURATE SCIENCE-BASED SOLUTIONS TO COVID-19

OTHER

Business Genre:
Business Description:

Ativa is focused on developing their Diagnostic Workstation product, which will be a unified, afforable diagnostic device utilizing microfluids and a machine-learning analysis system to screen for mutliple disease states and adapt to new diseases as they appear [5].

City:
St. Paul
State:
MN
Data/Evidence of Effectiveness:
“Safety and effectiveness have not been established.” [5].
Complimentary Products Needed to Perform Test:
Ativa Diagnostic Workstation, Microfluidic Test Card [5].
Setting of Care:
Ativa is targeting point-of-care facilities for their diagnostic workstation product [5].
Current Status / Clinical Development Stage / Expected Milestones:
“This device has not been evaluated, cleared, or approved for use by the FDA, and is not for sale in the US. Safety and effectiveness have not been established.” [5].
LOD:
Information not available
Funding & Ownership :
Private, venture (series unknown). Raised a total of $36.1 M over 5 funding rounds [4]
Business Model:
No products currently approved or on market. Developing thier Diagnostic Workstation, which will supposedly be able to diagnose multiple diease states from a small blood sample using microfluidic technology and an “artificial intelligence” cloud-based anaylsis network [5].
IP:
US10612070B2 (granted 04-07-2020, exp. 08-27-2035) US patent for “fluid holding and dispensing micro-feature” [6]. US9366606B1 (assigned 06-03-2019, exp. 08-27-2035) US patent on “fluid processing micro-feature devices and methods” [7]. US20190022651A1 (assigned 06-25-2019, pending status) US patent for “fluid holding and dispencing micro-feature” [8].
History & Origins :
Founded in 2008 [4], focused on developing a unified, affordable diagnostic platform that can test for multiple disease states [3, 5].
Date EUA Issued:
No EUA issued
Sources:
[1]https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization [2]https://ativamed.com/ [3] https://ativamed.com/about-us/ [4] https://www.crunchbase.com/organization/ativa-medical#section-overview [5] https://ativamed.com/technologies/ [6] https://patents.google.com/patent/US10612070B2/en?assignee=Ativa+Medical+Corporation [7] https://patents.google.com/patent/US9366606B1/en?assignee=Ativa+Medical+Corporation [8] https://patents.google.com/patent/US20190022651A1/en?assignee=Ativa+Medical+Corporation
Organization:
David Deetz (CO-founder, CEO); Barbara Roth (Co-Founder, COO, VP Manufacturing); Travis Murphy (CFO); Craig Dunphy (CMO); Jeff Young (CIO); Gulam Shaikh (VP R&D) [3]
No. Tests Per Day:
1 test/run x 1 run/0.05 hours x 24 hours/day=480 tests/day
Time to Result:
Results in 3-5 minutes (unproven) [5].
Test Sample Type:
One drop of blood from finger-stick or venous [5].
Technology Overview:
Ativa’s Diagnostic Workstation (under development) will be a desktop device for use in point-of-care facilities. Using microfludic test chips, a blood sample will be analyzed and uploaded into a cloud-based analysis software. This data ( a “Digital Blood Sample”) will be compared to other samples, and the artificial intellignece neural network will scan for patterns of known disease, while adapting to the patterns of new diseases. Ativa asserts that the system will be able to perfrom the most common diease screens, while also adapting to new diseases, such as COVID-19 [5].
Testing Type:
Microfluidic blood analysis, machine-learning sample analysis [5]. Combines “all five of the major blood, metablic and urine panels on one system.” [5].
Test Category:
Other
Test Name:
Ativa Diagnostic Workstation [5].
Clinical Application & Need:
Ativa aims to have their product used in point-of-care facilities globally, to detect common dieases, while also adapting to new diseases via machine-learning [5].
Age of Company:
12 years old, founded in 2008 [4]
Business Genre:
Business Description:

Company focus is home-based monitoring of cardiovascular diseases with a panel of clinically validated biomarkers [1]. They aim to improve the quality of point-of-care tests to meet needs of medical professionals. They collaborate with universities and hospitals in LA and partner with leading product development and manufacturing companies [1].

City:
Beverly Hills
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
N/A
Complimentary Products Needed to Perform Test:
Assuming all necessary supplies are provided in the kit since the company stresses on the ease of use at home and not requiring a lab or a technician [2].
Setting of Care:
At home and with healthcare providers [2].
Current Status / Clinical Development Stage / Expected Milestones:
Company announced plan to develop a rapid in-home test in April [4]. Seems like the product needs to be developed, sensitivity tests be run and EUA approval should be acquired before it’s available.
Funding & Ownership :
Private (undisclosed) venture backed [3].
Business Model:
They are a medical device company specializing in Semiconductor Physics, Biochemistry, Microfluidics, Si Devices, and Clinical Chemistry [3].
IP:
N/A
History & Origins :
Company was founded in 2014 [3]. Originated from years of academic research. FemtoDx provides the resources to solve some of the most challenging problems in healthcare. They perform product design, development, and manufacturing in partnership with the country’s leading companies [2]. It appears that their specialty is creating devices to detect heart failure and stroke before they occur [1].
Date EUA Issued:
N/A
Sources:
1. https://femtodx.com/ 2. https://femtodx.com/news/2020/3/31/femtodx-launches-rapid-at-home-test-development-for-covid-19 3. https://www.linkedin.com/company/femtodx/about/ 4. https://www.mddionline.com/fda-grants-eua-labcorps-home-covid-19-test
Organization:
“Raj Mohanty, PhD- CEO, Founder & Board Member Shyam Erramilli, PhD- Founder, SAB Chairman Sanjiv Taneja- Chief Operating Officer David Weaver, PhD- Chief Scientific Officer Stan Lapidus- Senior Advisor Carla Sivak- Regulatory & Quality Affairs Hiroo Awano- Corporate Development Robert Dinello, PhD- Director of Assay Development Patrick Anquetil, PhD- Board Member Rahul Baldota- Board Member Steve Steinhubl, MD- Advisor Sudhakar Pamarti, PhD- Advisor [1].”
No. Tests Per Day:
serology strip >2000/ day
Time to Result:
Under 5 minutes [2].
Test Sample Type:
N/A
Technology Overview:
Specifics N/A. The test seems to still be in development [2,4]. Patients can perform the test themselves at home without needing a lab or technician [2]. More importantly, time from sample to result is less than five minutes [2].The test will be performed by the patients at home, or by health care providers at other points of care, with an easy-to-use device, which is connected to the cloud and patients’ electronic medical records for immediate intervention when needed [2]. FemtoDx’s test uses the same indicators that are analyzed in a traditional reference lab [2]
Testing Type:
N/A
Test Category:
Other
Test Name:
COVID-19 Test [1,2]
Clinical Application & Need:
Rapid diagnostic test to allow patients and providers to reliably determine whether they have a COVID-19 infection and help reduce the spread of the virus [2].
Age of Company:
2014 [3]
Business Genre:
Business Description:

They design solutions for advanced visualization and universal 3D imaging processing to accelerate medical image interpretation [1]

Country:
France
Data/Evidence of Effectiveness:
N/A
Complimentary Products Needed to Perform Test:
Need the Myrian image layer [3]
Setting of Care:
Should be in the clinical lab setting
Current Status / Clinical Development Stage / Expected Milestones:
Not FDA cleared/approved; FDA approved to meet EUA criteria [2]. Under EUA, cGMP requirements have been waived [2]; for in vitro diagnosis of SARS-CoV-2 infection [2].
Funding & Ownership :
Public [4], Cap 17.785 M [5]
Business Model:
They sell Myrain, the software solution for advanced visualization and analysis of multimodality medical images [1]
IP:
Certificate with ISO 13485 [1]
History & Origins :
Found in 2004. Combined skills in IT, math, engineer, and healthcare in solution for medical imging [1]
Date EUA Issued:
Myrian has been FDA cleared in 2007 [1]
Sources:
“[1] http://www.intrasense.fr/company/#our-mission [2] http://www.intrasense.fr/myrian-covid-19-protocol/ [3] http://www.intrasense.fr/myrian-imaging-layer/ [4] https://www.crunchbase.com/organization/intrasense-sa#section-overview [5] https://finance.yahoo.com/quote/ALINS.PA?p=ALINS.PA&.tsrc=fin-srch [6] https://www.linkedin.com/in/nicolasreymond/?originalSubdomain=fr”
Organization:
Nicolas Reymond (CEO) [6]
Time to Result:
N/A
Test Sample Type:
CT, radiology scan [2]
Technology Overview:
Based on the Myrain XP-Lung, lung range automatic segementation tool. Provide an measure of lung impairment and reserve in patients automatically and intuitively [2]
Testing Type:
radiology visualization, CT scan [2]
Test Category:
Other
Test Name:
Myrian Covid-19
Clinical Application & Need:
acute infection
Age of Company:
2004
Business Genre:
Business Description:

PinPoint Science Inc. is a small company that was founded by Nader Pourmand, “Professor of Biomolecular Engineering and director of the UCSC Genome Technology Center at the University of California Santa Cruz, Baskin School of Engineering” [2]

City:
Berkeley
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
They show some data detecting H5N1, HPV, and Bluetongue virus with nanopipettes and nanosensor chips on their website, but show no data for SARS-CoV-2 [3]. It seems like they have not chosen the antibody or apatamer that they will use for detection [3].
Complimentary Products Needed to Perform Test:
Nasopharyngeal swab or other sample collection device [3]
Setting of Care:
For use in a small clinic or at home [3]
Current Status / Clinical Development Stage / Expected Milestones:
“They are still in the development stage, but they planto functionalize their sensors to antibodies or aptamers against SARS-CoV-2 in June. It is not clear how much progress they have made on this front. Their goal is to get EUA approval in September. [3] “
Funding & Ownership :
It appears that they are funded by a few small grants. [3]
Business Model:
It seems like they are very early stage
IP:
They say that they have a patent pending for this technology [3] , and they have several patents related to nanopipette technology [4,5]
History & Origins :
It seems like the company was founded in 2017 and has been collecting data and small grants since then [1]. Nader Pourmand is a “Professor of Biomolecular Engineering and director of the UCSC Genome Technology Center at the University of California Santa Cruz, Baskin School of Engineering” . “Pourmand and his team hold over twenty patents. Pourmand has been published in more than 80 scientific journals including the Oxford University Press, Cancer Research, PLoS ONE and the Proceedings of the National Academy of Sciences. ” [1]
Date EUA Issued:
In development, their goal is to goal EUA approval in September [3]
Sources:
[1] https://pinpointscience.com [2]https://pinpointscience.com/team [3] https://pinpointscience.com/covid-19-test [4] https://patents.google.com/patent/US9228971B2/en?inventor=Nader+Pourmand&oq=Nader+Pourmand [5] https://patents.google.com/patent/US9766204B2/en?inventor=Nader+Pourmand&oq=Nader+Pourmand [6] https://pinpointscience.com/team
Organization:
CEO: Lisa Diamond, Founder: Dr. Nader Pourmand [6]
No. Tests Per Day:
>2000 samples/day
Time to Result:
30 seconds [3]
Test Sample Type:
They claim that their device can detect samples from swabs, blood, saliva, and more, but it is not clear if this applies to SARS-CoV-2 [3]
Technology Overview:
PinPoint’s device consists of a handheld console that communicates wirelessly with a Smartphone. A cartridge in which a nasal swab is inserted must be plugged into the console. They claim that they can get a diagnosis within 30 seconds and that the device costs only $100. This technology uses a “multichannel nanosensor chip” that is made by Analog Devices. How it works is that they functionalize antibodies or aptamers to nanopipette or nanosensor tips and upon antigen binding the current measured by the sensor is decreased. This decrease in current is detected by a circuit in the console and this info is relayed to the smartphone. [3]
Testing Type:
detection of either SARS-CoV-2 proteins or RNA [3] It seems like they have not chosen the antibody or apatamer that they will use for detection [3].
Test Category:
Other
Test Name:
Pinpoint Covid-19 Screening Assay
Clinical Application & Need:
acute infection [3]
Business Genre:
Business Description:

Predigen Inc is a small company founded by Duke University professor Geoffrey Ginsburg, probably in 2018 [1] [2]

Business Genre:
Business Description:

Biotechnology company especializing in antiviral assays and cell-based screening for antiviral compounds [2]

City:
San Diego
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
The company offers several neutralization in vitro assays and now offers SARS-CoV-2 pseudoviruses that can be used to test vaccines [6]. No data was found
Complimentary Products Needed to Perform Test:
N/A
Setting of Care:
N/A
Current Status / Clinical Development Stage / Expected Milestones:
The company is “optimizing assays against the live infectious SARS-CoV-2” [4]. V9
Funding & Ownership :
Privately; Last funding type was a grant; Estimated revenue $1-10M [1-2]
Business Model:
The company offers a number of AAV neutralization assays including one for Influenza [5]
IP:
proprietary product pipeline of novel small-molecules with antiviral and immunomodulatory properties [3]
History & Origins :
“RetroVirox was founded with an initial investment by scientists and entrepreneurs to translate into cures research previously funded by the National Institutes of Health (NIH)” [2]
Date EUA Issued:
N/A
Sources:
[1] https://www.crunchbase.com/organization/retrovirox; [2] https://retrovirox.com/ABOUT_US.html; [3]https://retrovirox.com/Pipeline.html; [4] https://retrovirox.com/Coronavirus_Antiviral_Services_-_RetroVirox,_Inc..html [5]https://retrovirox.com/AAV_Neutralization_Assays_-_RetroVirox,_Inc..html [6] https://www.retrovirox.com/News/Entries/2020/3/17_RetroVirox_Launches_Coronavirus_Assays_to_Evaluate_COVID-19_Vaccines_and_Therapeutics.html
Organization:
Juan Lama, PhD (Chief Scientific Officer), Isabel Cisneros (Program Manager) [2]
Time to Result:
N/A
Test Sample Type:
N/A
Technology Overview:
The assay uses “HIV pseudoviruses coated with the viral spike (S) protein of SARS-CoV-2 (Wuhan isolate)” that can be used to determine “neutralizing activity of therapeutic antibodies”, “test experimental COVID-19 vaccines” and “evaluate small-molecule entry inhibitors targeting the S viral protein, the ACE-2 viral receptor, or host proteases and other targets involved in SARS-CoV-2 viral entry” [4]
Testing Type:
N/A
Test Category:
Other
Test Name:
SARS-CoV-2 Pseudovirus assay for Neutralizing Antibodies
Clinical Application & Need:
future prevention/ treatment
Business Genre:
Business Description:

The initiative is a web portal sponsors academic and independent study on CoV-19. The initiative is started by Robert Rhinehart, partner of MarsBio. MarsBio is a biotech venture capital and supports the initiative. [2] [3] [4]

City:
Los Angeles
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
N/A
Complimentary Products Needed to Perform Test:
in development
Setting of Care:
N/A
Current Status / Clinical Development Stage / Expected Milestones:
The COVID-19 Response website launched by MarsBio claimed the product was currently in validation and would be on the market soon [4]
Funding & Ownership :
Funded by MarsBio (a synthetic bio, biotech and deep tech venture capital fund)
Business Model:
Through the initiative, MarsBio is intended to sponsor scientific projects in CoV-19 diagnostics, containment and treatment. The initiative also works on study of neutralizing antibody and viral capsid structure, virus pseudotype production, and antibody therapy. [6]
IP:
N/A
History & Origins :
MarsBio funded various types of CoV-19-related projects, including breathtronics, EpitopeRX vaccine, N95 masks and hand sanitizer. [7]
Date EUA Issued:
in development
Sources:
“[1] https://www.crunchbase.com/organization/marsbio#section-overview [2] https://www.marsbio.vc/media/covid-19-task-force [3] https://www.covid19-response.com/task-force [4] https://www.covid19-response.com/initiative-progress [5] https://www.corona-initiative.com/detection [6] https://www.covid19-response.com/projects/project-one-6bkxs-hd7hc-e2b6s [7] https://www.covid19-response.com/projects”
Organization:
Robert Rhinehart (founder of Soylent, partner of MarsBio)
Time to Result:
expected to be faster than serological antigen tests [5]
Test Sample Type:
saliva samples [5]
Technology Overview:
lateral flow assay for whole virus and virus particle detection [5]
Testing Type:
saliva antigen test [5]
Test Category:
Other
Test Name:
Viral Direct Detection At Home Test
Clinical Application & Need:
acute infection