Dr Boreham’s Crucible: Testing times for Covid assay developers...

Dr Boreham’s Crucible: Testing times for Covid assay developers
Health & Biotech
October 1, 2021 | Tim Boreham

Despite the “grave risk to public health” posed by wrongly administering or reading point-of-care Covid-19 tests, such rapid assays are about to hit pharmacy shelves after winning the green light from the Therapeutic Goods Administration.

The health regulator had already approved around 30 rapid antigen tests, but the approval means they can be self-administered tests that can be used at home (or elsewhere) without the learned interpretation of a healthcare specialist.

Given health minister Greg Hunt has flagged the regulator’s assent “in coming months, if not weeks”, we shouldn’t be surprised the TGA fell into line.

Assent also seemed inevitable because rapid tests are already approved in other key jurisdictions including US and Europe. Aldi sells off the shelf tests in its German stores (they sell for 25 Euros, or $A39 for a pack of five if you really want to know).

Early on in the Covid crisis, ASX-listed healthcare diagnostics companies were quick to jump on the rapid-testing bandwagon. Some have succeeded, some are kind of getting there and others have fallen off the rolling conveyance with a thud.

Last week, Lumos Diagnostics had a setback when the US Food & Drug Administration (FDA) “deprioritised” the company’s application for approval of emergency use of its Covid-19 test.

Does that mean the corona-crisis is over?

The tests discussed, by the way are for Sars-Cov-2, the underlying virus that causes Covid-19. But for the sake of simplicity our nomenclature will be Covid, or ‘the plague’.


Lumos Diagnostics (ASX:LDX)

The FDA last week said it had “ceased review” of Lumos’s rapid antigen test, Covidx, sending the shares down 12 percent.

Lumos remains in active dialogue with the regulator and is preparing additional data to support s fresh application, as you do. The test is already approved in Europe.

Lumos listed on July 5 this year, having raised a chunky $63 million.

The company’s flagship product is not Covidx but Febridx, a finger-prick blood test that can distinguish between bacterial and viral infections (such as Covid) within 10 minutes.

Lumos is also developing Viradx, “which simultaneously tests for Covid-19 and influenza and has the potential to satisfy an even greater public health need”.

As extension products of Febridx, the company is developing Uridx for urinary tract infections and Sepsidx (for the often-fatal blood infection sepsis).

Of Lumos’s revenue of $25 million in the 2020-’21 year, $22.7 million derived from commercial services (white-label assay and digital reader development and manufacturing for other parties)

Lumos also posted a $14.5 million loss, but one has to break a few eggs to make an omelette.

https://unauthorised investment adv...ble-testing-times-for-covid-assay-developers/