AT1 OEM Contracts (various)

New thread for info/discussions about AT1's various OEM device supply contracts

So far, AT1 is supplying devices for pregnancy tests (NG Biotech), FebriDx screening test (Lumos Diagnostics), Malaria (Mylan) and has advised other OEM discussions are in the pipeline. FY20 sales revenue $0.8m for 266k devices sold

Lumos Diagnostics' (FebriDx screening test) - mentioned in AT1 FY20 Results ppt (pg 13);
- website: https://lumosdiagnostics.com/
- Lumos' company goal: '...enable point-of-care testing to be more accessible, facilitating the migration of diagnostic testing out of laboratories, directly to where it’s really needed.'

History
- Lumos is a private company, developed and spun off by Plant Innovation company (which is a biz venture capital company whose goal is to '...incubate, grow and, at the right time, spin-off high value technology businesses as independent entities').
- Lumos Diagnostics merged with RPS Diagnostics in July 2019 (retained its name) (RPS also was a Florida-based developer and manufacturer of POC diagnostic tests so the merger combined manufacturing + diagnostic dev in the new entity)

Planet Innovation company: https://planetinnovation.com/our-businesses/
Merger news: https://planetinnovation.com/perspectives/lumos-diagnostics-merges-with-rps-diagnostics/

What is a FebriDx screening test? https://www.febridx.com/

- Its '...a world-first rapid point-of-care test that can differentiate a viral from bacterial infection in patients with Acute Respiratory Infection'.
- already AU TGA approved + EU CE marked; US trials seem underway

- Lumos is focused on internationally marketing its FebriDx test as its sees a global market need for anti-bacterial vs viral infection screening needs.
- won $15m in funding from its parent company (Planet Innovation) to back a U.S. FDA pivotal clinical trial, as well as additional development and manufacturing resources (https://www.bioworld.com/articles/432880-lumos-diagnostics-scoops-up-15m-in-series-a-to-back-febridx-test)

- This test uses AT1 RDT device only. Pictures of this in all the news + websites I have referenced here

(news articles) 'Physicians are currently unable to easily distinguish bacterial from viral infections, which has led to the global problem of over-prescription of antibiotics. FebriDx enables doctors to get a result in under 10 minutes, empowering them to make more informed decisions when treating patients.'

(FebriDx website) 'Unnecessary use of antibiotics leads to antibiotic resistance, causing more than 25,000 deaths in the EU, and 700,000 globally.8-9 Antibiotic resistance results in costs over €1.5 billion in the EU and $20 billion in the U.S. annually'. 'FebriDx can be used to help triage patients at the point of care to reduce uncertainty and avoid unnecessary antibiotics'.

And FebriDx is being marketed for 'Covid19' initial screening protocols:https://www.febridx.com/covid-19-triaging

Seems they already have piloted this test with Victoria state gov support (Mar 2020)
https://planetinnovation.com/perspectives/pi-and-lumos-work-with-victorian-government-to-pilot-febridx-as-acute-respiratory-infection-patient-triage-tool-in-response-to-covid-19-pandemic/-
- '...working with the Victorian Government to demonstrate the benefits and impact that the FebriDx® test may deliver as an acute respiratory infection (ARI) patient triage tool in the Australian healthcare system.'
- study published (June 2020): https://www.journalofinfection.com/article/S0163-4453(20)30432-1/fulltext. Conclusions support '...rapid, highly accurate, and affordable 'front door triage tool' to help healthcare providers differentiate viral from bacterial infection in patients with suspected COVID-19'

Points from FebriDx website:

- identify those patients that should undergo further pathogen specific testing (e.g. Coronavirus, Flu A/B) when the FebriDx result is positive for viral infection

- limit unnecessary antibiotic prescriptions that lead to antibiotic resistance when the FebriDx result is negative for bacterial infection

- Clinical performance from two prospective multi-center US clinical trials demonstrate the FebriDx test’s high accuracy and 97-99% negative predictive value to exclude a bacterial infection.

- United Kingdom outcome study, FebriDx was shown to alter clinical management decisions in 48% of patients tested and reduced unnecessary antibiotic prescriptions by 80%.

- FebriDx was highly accurate in identifying COVID-19 infections and detected cases that were missed by SARS-CoV-2 RT-PCR

- FebriDx viral negative patients can be rapidly cohorted in non-COVID-19 areas allowing viral positive patients to be immediately isolated whilst awaiting confirmatory PCR testing.

- FebriDx could be rapidly deployed as a front door triage tool in hospitals and urgent care centers to overcome current issues of delayed diagnosis from PCR testing.