# Oncimmune Holdings and Biodesix, Inc. Commence Commercialisation of EarlyCDT® Lung

- Link: https://www.directorstalkinterviews.com/oncimmune-holdings-and-biodesix-inc-commence-commercialisation-of-earlycdt-lung/412796912
- Published: 2019-11-01T07:16:48+00:00
- Author: Giles Arbor

**Oncimmune Holdings plc** (LON: ONC), a leading global immunodiagnostics Group,
have announced the completion of the strategic commercialisation agreement with 
Biodesix, Inc. for EarlyCDT Lung in the United States, which was announced on 28
June 2019.

We believe this agreement will unlock the potential of EarlyCDT Lung in the US, 
a key strategic market for Oncimmune. Biodesix is a leading lung cancer diagnostic
solutions company which has now commenced the commercialisation of EarlyCDT Lung.
Biodesix will make increasing volume-based revenue-sharing payments to Oncimmune
from its sales of the EarlyCDT Lung test.

To satisfy the expected growth in sales volumes, Oncimmune will provide Biodesix
with diagnostic plates and associated reagents under a profitable supply agreement
which was also signed today. Biodesix’s current sales force of around 30 is set 
to increase to over 80 over the next two years, enabling wider reach across the 
US.

Under the terms of the commercialisation agreement, Biodesix today completed the
acquisition of Oncimmune’s CLIA laboratory facilities in Kansas, US and will pay
$1.0 million to Oncimmune in quarterly instalments of $250,000, with the first being
made within 30 days from today. The sale of Oncimmune’s US laboratory operations
will materially improve the Company’s cash position through a reduction of ongoing
US operating costs, which were approximately $3.2 million over the past 12 months.

Biodesix is focused on exploiting the full potential of EarlyCDT Lung by extending
the utility of the test to screening in the US. To facilitate this significant opportunity,
Oncimmune has granted Biodesix an option to commercialise EarlyCDT Lung as a screening
diagnostic for lung cancer in the US in exchange for a further significant cash 
payment. The option is exercisable by the end of 2020. Following the announcement
by the Company on the 4 June 2019 that the Early detection of Cancer of the Lung
Scotland (“ECLS”) trial had met its primary end-point, it is the Board’s belief 
that lung cancer screening, over and above the current lung nodule application, 
increases substantially the total addressable market for EarlyCDT Lung in the US,
and indeed, in all other major markets.

This strategic commercialisation agreement with Biodesix represents value to Oncimmune
of up to $28 million in the five-year period to 1 November 2024, of which approximately
$7.2 million derives from minimum volume-based revenues. The balance of approximately
$20.8 million is represented by both cash lump sum payments, including the $1.0 
million sale of Oncimmune’s US subsidiary’s operations, as well as the significant
payment that will be due if the screening option is exercised, together with the
material cost savings resulting from a reduction in US operating costs. The Agreement
can be renewed by Biodesix for a further five years to 1 November 2029, and by mutual
agreement thereafter.

Oncimmune will also continue to collaborate with Biodesix on research and development
activities in order to fully leverage the commercial potential of EarlyCDT Lung 
in the US.

**Dr Adam M Hill, CEO of Oncimmune Holdings commented: **

> “We are delighted to be working with Biodesix, a company with a successful track
> record of commercialising clinical diagnostic lung tests in the US and dedicated
> to improving patient management and outcomes. Biodesix is focused on extending
> the utility of EarlyCDT Lung to screening in the US, and this partnership, which
> fully realises the value of EarlyCDT Lung, will accelerate market access and save
> lives through earlier detection of lung cancer.
> “This partnership and other agreements announced this year, demonstrate our ability
> to deliver on the core objective to drive organic growth through commercial collaborations.
> In addition, we have secured further funding through a credit facility arrangement,
> which puts us in a strengthened cash position to deliver on our three-year forward
> strategy.”

**David Brunel, CEO of Biodesix commented: **

> “More than 1.6 million patients a year in the US are found to have an incidental
> pulmonary nodule, and most of these patients do not have cancer. Avoiding unnecessary
> invasive procedures and expediently moving those with cancer into treatment are
> equally high priorities, and with our current Nodify XL2 and now with EarlyCDT
> Lung, Biodesix brings the most comprehensive, simple, blood-based testing solutions
> to address this urgent problem.”

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