Hundreds of millions of dollars are available to small biotechnology and medical device businesses to fight COVID-19. The money is in the form of non-dilutive grants, contracts,  and also in exchange for equity positions in your company. For example start-up incubators may offer small seed funds of $25,000-$50,000 in exchange for residency, mentorship and an equity position in your company. Other funding includes large multi-year grants of $5,000,000 or more offered by the Department of Defense. The monies may bring forth the best and brightest ideas from biotechnology and medical device start-ups and other small businesses. These funded innovations could be critical in the fight against COVID-19 and other infectious diseases. The solutions to the current crisis may help us improve healthcare and disaster readiness for years to come.

The money is coming from public and private sources. For-profit and non-profit institutions. Military and civilian agencies. These funding sources accelerate the development and availability of transformative technologies and approaches to protect Americans from health security threats. Here is a partial list and links to some of the Health and Human Services and Department of Defense  related funding agencies: NIH-SBIR (https://www.sbir.gov/) , CDC (https://www.cdc.gov/) , BARDA (https://www.medicalcountermeasures.gov/barda/) , DARPA (https://www.darpa.mil/), MTEC (https://www.mtec-sc.org/) , MCDC https://www.medcbrn.org/).

Department of Defence (DoD) Consortiums like MTEC and MCDC, facilitate DoD and industrial relationships and funding agreements . Today they are advancing countermeasures to COVID-19 and other infectious diseases. The mission is to protect the population and improve war fighting capabilities.  These agencies also understand that the funding helps small businesses survive in tough times and the military has a clear need to promote resilience of the defense industrial base during the COVID-19 pandemic. Biotechnology solutions, point of care medical devices, and therapeutics have become the armaments of the war on pandemics.

Philanthropic organizations such as the Bill and Melinda Gates Foundation and the Chan Zuckerberg Initiative are offering funds to fight COVID-19 and care for the sick. These types of organizations can provide expert advice and support to start-ups to bring their solutions to the COVID-19 induced healthcare crisis. 

Several start-up Incubators such as SOSventures/IndieBio, QB3, J&J Innovation Centers are offering seed funds ranging from $25,000 to $250,000 in exchange for an equity stake in the venture. The COVID-19 specific offerings have an urgency to them not seen in the past.The announcements are occuring at a fast clip in March and April. Often applicants are given days to weeks to respond with a technical proposal and detailed budget. Often the product or idea must be completed and ready for deployment  in 3-12 months. The areas of interest include Point of Care Diagnostics, Prophylactics, Ready-to-Go Therapeutics, Medical Devices, Protective Gear

Computer Modeling, Disease Tracking, and AI for Drug Discovery.

BioTether Sciences is proud to be a member of Medical Technology Enterprise Consortium, (MTEC), the NIH-Small Business Innovative Research (SBIR) program, and the State and Federal systems for award management (eProcure, and betaSAM.gov). We are developing technologies for diagnostics, prophylactic and therapeutics to fight COVID-19. Our technologies exploit high affinity interactions between target-receptor, antigen-antibody and other ways macromolecules interact.

(Created using information from the CDC.gov website)

The CDC works closely with state and local public health departments, travel industry partners, and others to identify and test people who may be infected with COVID-19. There are  several different laboratory tests to detect COVID-19 infection. The testing strategy is based on experience from the SARS and MERS outbreaks.

In general, these lab tests fall into two categories:

• Molecular tests, which look for evidence of active infection; and
• Serology tests, which look for previous infection by detecting antibodies to COVID-19. Serology tests are for surveillance or investigational purposes and not for diagnostic purposes.

Molecular Tests

Molecular tests are used to diagnose active infection (presence of COVID-19) in people who are thought to be infected based on their clinical symptoms and having links to places where COVID-19 has been reported.

• Real-time reverse-transcription polymerase chain reaction (rRT-PCR) assays are molecular tests that can be used to detect viral RNA in clinical samples. CDC’s current case definition for laboratory confirmation of COVID-19 infection requires a positive rRT-PCR result for at least two specific genomic targets. Sequencing may also be used as a confirmatory test.
• Increasingly laboratories in the United States are approved to test for COVID-19 by using an rRT-PCR assay developed by CDC. This test is done under authority of an Emergency Use Authorization because there are no FDA-cleared/approved tests available for this purpose in the United States.
• The success of rRT-PCR testing depends on several factors, including the experience and expertise of laboratory personnel, laboratory environment (e.g., avoidance of contamination), and the type and condition of specimens being tested. For this rRT-PCR assay, CDC recommends collecting multiple specimens, including lower (bronchalveolar lavage, sputum and tracheal aspirates) and upper (e.g., nasopharyngeal and oropharyngeal swabs) respiratory samples, serum, and stool specimens.
• CDC considers a person under investigation to be negative for active COVID-19 infection following one negative rRT-PCR test on the recommended specimens. Since a single negative result does not completely rule out infection, in some circumstances additional specimens may be tested.
• CDC considers a known the patient to be negative for active COVID-19 infection following two consecutive negative rRT-PCR tests on all specimens.

Serology Tests

Serology testing is used to detect previous infection (antibodies to COVID-19) in people who may have been exposed to the virus. Antibodies are proteins produced by the body’s immune system to attack and kill viruses, bacteria, and other microbes during infection. The presence of antibodies to COVID-19 indicates that a person had been previously infected with the virus and developed an immune response.

• Evidence to date suggests there may be a broader range of COVID-19 disease than was initially thought. For this reason, public health scientists are working to learn more about how the virus is transmitted. One way to do this is through voluntary testing of blood samples from people who had close contact with people known to have COVID-19.
• CDC has a two-phase approach for serology testing, using two screening tests and one confirmatory test to detect antibodies to MERS-CoV.
• ELISA, or enzyme-linked immunosorbent assay, is a screening test used to detect the presence and concentration of specific antibodies that bind to a viral protein.
• The microneutralization assay is a highly specific confirmatory test used to measure neutralizing antibodies, or antibodies that can neutralize virus. This method is considered a gold standard for detection of specific antibodies in serum samples. However, compared with the ELISA, the microneutralization assay is labor-intensive and time-consuming, requiring at least 5 days before results are available.
• If a clinical sample is positive by either ELISA, and positive by microneutralization, the specimen is determined to be confirmed positive.
• If a clinical sample is positive by both ELISAs, and negative by microneutralization, the sample is determined to be indeterminate.
• If a clinical sample is positive by only one ELISA, and negative by microneutralization, the sample is determined to be negative.
• If a clinical sample is negative by both ELISAS, the sample is determined negative.
• In the end, a final determination of a confirmed positive serology result requires a positive ELISA test and confirmation by microneutralization assay.