Biocurious: Lumos shines a light on the post-pandemic rapid diagnosis sector

Lumos Diagnostics is striving to become the leader in simple point-of-care tests to distinguish between viral and bacterial infections in 10 minutes.

Lumos Diagnostics is shining a new path in the rapidly growing point of care diagnostics sector. Pic via Getty

• Lumos is commercialising its FDA-approved Febridx test to distinguish between viral and bacterial infections

• The company’s original Viradx flu assay was affected by a flood of cheap Chinese tests

• Lumos is also developing a test to predict – and prevent – premature births

 

Lumos Diagnostics (ASX:LDX) CEO Doug Ward knows too well how quickly the competitive landscape for a medical device can change – and he has learnt some valuable lessons from the experience.

A year ago, the point-of-care diagnostics house was riding its fortunes on the back of Viradx, its US Food & Drug Administration (FDA) approved test for Covid and influenza A and B.

But a flood of Chinese and South Korean companies entered the US market, ahead of the last flu season.

While users liked Viradx, Lumos was forced to drop its price from US$12 to test to US$9 – but the rivals were selling theirs for US$3.

“They are now selling at a third of what our product sold at last year,” says the US-based Ward.

“It’s not a robust market for us.”

Despite this aggressive pricing, Lumos reports new customer adoption owing to the severe US flu season.

Tapping his healthcare experience over three decades, Ward has focused Lumos's attention on its Febridx test, which can distinguish between bacterial and viral infections in ten minutes.

This is done by measuring two biomarkets simultaneously.

Approved by the FDA in October 2023, Febridx targets the over-use of antibiotics which contributes to the huge problem of antimicrobial resistance.

Let there be light

Lumos is a spin-off from the Melbourne-based Planet Innovation, which has a sound reputation for medical device design and development.

Lumos is chaired by Planet Innovation CEO Sam Lanyon.

Meaning ‘light’, Lumos debuted at the height of the pandemic in July 2021, having raised $63 million.

Lumos specialises in rapid point-of-care (POC) tests, to help healthcare professionals diagnose and manage medical conditions more accurately.

The kits are lateral flow, which means the sample flows horizontally over a strip containing the test reagents.

Lumos’s offerings include customised assay development and manufacturing services for third-party POC tests, as well as proprietary digital reader platforms.

Andrew and Nicola Forrest’s Tenmile Ventures last year became a 19.9% Lumos shareholder, having acquired its stake from Planet Innovation.

Let’s be CLIA – it’s important

The FDA’s Febridx  approval came after the agency initially rejected Lumos’s submission, in 2022.

The agency opined that while the assay proved its chops at the bacterial-versus-viral bit, the agency was worried about false negative Covid results.

“The knock-back was a surprise because we met all the performance endpoints,” says Ward.

There’s a complexity, in that the company had requested a so-called CLIA (Clinical Laboratory Improvements Amendment ) waiver.

The provision is for simple tests that have an insignificant risk of an erroneous result and can be used by less trained staff such as nurses and receptionists.

“It still needs to be in a healthcare setting, but that’s it,” says Ward.

Other examples of CLIA assays are blood glucose, urine pregnancy and bowel cancer poo tests.

Currently, the FDA approval relates to ‘moderate to complex’ uses by a trained clinician.

Ward says  the current market accounts for only 5% of the US$1 billion a year addressable market.

“That’s why a why a CLIA waiver is so important to us,” says Ward.

“It will transform the company, big time.”

US government backed? You BARDA believe it

In its quest for CLIA status, Lumos in December launched a supportive study, with 350 patients tested to date.

The US disaster preparation agency, BARDA, is ponying up US$3 million to run the trial (contingent on various milestones).

The agency is also contributing up to US$5.3 million for a paediatric study.

While the trial is progressing well, there has not been enough bacteria-positive patients to power the study properly.

One reason is the bad but late US flu season meant here was over-representation of viral patients.

In its March quarterly report yesterday, the company reported that of the 351 patients tested to date, 37 had a bacterial infection, whereas a minimum 120 ‘bacterials’ are needed to prove statistical significance.

Fortunately, the FDA has allowed an ‘enrichment’ process, by which Febridx can confirm patients already known to have the streptococcal A bacterial infection.

“Hopefully that will move us along a lot quicker,” says Ward.

The company targets study completion – and an FDA filing – in the December half.

Febridx addresses the issue of rampant over-use of antibiotics.

According to the US Centers for Disease Control and Prevention, more than 200 million antibiotic prescriptions are written each year.

About half are for acute respiratory tract infections and about 40% are unnecessary.

Women’s health

Lumos’s s next foray is in women’s health, in collaboration with the Massachusetts-based women’s’ health specialist, Hologic.

The parties are developing a next-generation test for foetal fibronectin (FFN), a biomarker that points to a higher risk of pre-term births.

Under a US$10 million agreement, Lumos has licensed its proprietary reader and POC tech to Halogic.

Lumos also has dibs on up to US$5.5 million of milestone-based development payments from Halogic over two years.

The assay would replace the Halogic’s current ageing FFN test, which is the only one on the market.

Lumos says the FFN work is “progressing well”, albeit about four months later than planned.

Old friends

In early 2023  the then cash-strapped Lumos vended some of the manufacturing equipment at its Carlsbad, California facility to Hologic, under a sale and leaseback arrangement.

This resulted in a $5.9 million in non-dilutive funding.

Hologic and Lumos know each other well, because Ward was business development manager for Hologic and Hologic was one of Lumos’s biggest customers.

“There is a roadmap to develop other products with them as well,” says Ward.

“There’s no point having a reader in a clinic only able to do one test, it takes up too much space.”

Outside of the Hologic tie-up, Lumos is mulling its own suite of women’s health tests, for conditions including urinary tract and yeast infections and vaginitis.

“Most of these tests are done and sent to the lab and it takes days for a turnaround,” says Ward.

The company plans five to six tests, with the first two to be revealed in the December half.

Getting paid

As we’ve opined previously, regulatory approval amounts to a hill of beans without robust reimbursement in place.

In April Lumos secured Febridx reimbursement coverage for four Medicare Administration Contractors (MACs), at US$41.38 per test.

This takes coverage to four of the seven MACs, or 55% of total Medicare coverage.

Management is confident of snaring the remaining three.

“Medicare adoption generally serves as a precedent for reimbursement decisions by private insurance payors,” notes Lumos.

Febridx will drive growth

Lumos posted March quarter revenue of $3.5 million, 21% better than the December quarter tally.

Cash outflows were US$1.3 million, compared with a US$3.7 million deficit previously.

Of the revenue, 80% was derived from contract services for drug, diagnostic, food and environmental testing companies.

A company review in mid 2022 enunciated the services side as a key priority.

Having said that, Febridx offers the strongest growth prospects in a world in which clinicians and patients want an answer now, rather than when the lab decides to return a result.

Research platform MST Access says: “the global healthcare system increasingly is prioritising rapid diagnostic solutions, particularly in infectious disease management and antibiotic stewardship.

“Lumos’s proprietary technology addresses this need with point-of-care solutions that reduce the time to diagnosis and treatment.”

Originally published as Biocurious: Lumos shines a light on the post-pandemic rapid diagnosis sector