The ASX healthcare sector roared back this week, giving investors a welcome little present. Pic: Getty Images
ASX health sector up 2.66% for the past five days while broader market rises 2.81%
Lumos secures US CLIA-waiver for its flagship point-of-care (POC) respiratory test FebriDx
Amplia reports four new confirmed responses from its combination phase Ib/IIa pancreatic cancer
Healthcare and life sciences expert Scott Power, who has been a senior analyst with Morgans Financial for 27 years, gives his take on the ASX healthcare sector for the week and his ‘Powerplay’ stock pick.
After seven weeks in the red, the ASX Healthcare sector has managed to return to positive territory this week.
At close on Friday, the S&P/ASX 200 Health Care Index (ASX:XHJ) was up 2.66% over the past five trading days, while the benchmark S&P/ASX 200 (ASX:XJO) rose 2.81% over the same timeframe.
He said the market was still very much macro driven with commentary from US President Donald Trump on the Middle East conflict swaying markets in either direction, along with news on inflation, slowing economies and supply issues.
“After a series of down weeks we’re up this week but it’s still a very nervous or risk off investor environment,” Power said.
Locally, on it has been a week for positive news flow for ASX healthcare, providing a much needed boost to the sector.
Lumos achieves key regulatory milestone, undertakes capital raise
The US Food and Drug Administration (FDA) has granted a CLIA waiver following 510(k) clearance for Lumos Diagnostics’ (ASX:LDX) flagship point-of-care (POC) respiratory test to differentiate between a virus and bacterial respiratory infection FebriDx.
Granting of the waiver expands FebriDx usage beyond moderate complexity clinical settings to more than 300,000 locations US healthcare market including physician offices, urgent care clinics, retail health and pharmacy clinics and community health centres that hold a Certificate of Waiver.
It unlocks access to a US$1 billion-plus market opportunity – around 15 times larger than previously addressable – and expanding potential use to ~80 million patients annually across more than 300,000 healthcare locations.
Granting of the waiver also triggers a milestone payment of US$5.5 million under a US$317m distribution agreement with PHASE Scientific.
Lumos will also receive a US$507,377 milestone payment from the US Biomedical Advanced Research and Development Authority (BARDA), who has contributed to funding the CLIA-waiver project .
In further good news, Lumos has completed a strongly supported US$14m (A$20m) placement to institutional, professional and sophisticated investors, and will launch a Share Purchase Plan (SPP) targeting a further $2m for existing shareholders.
Existing shareholders Ryder Capital and Tenmile have also confirmed they will exercise at least 43.9 million options, providing an additional $3.1 million.
“It is a major milestone for Lumos to get the CLIA-waiver in the US and on the back of that they’ve had a capital raise to help fund their sales and marketing efforts,” Power said.
“The company has done a terrific job over the last 12-months or more and gone from around 2 cents to 28 cents so been one of the sector’s great success stories.
“It is these sort of success stories which bring investors back into the sector and particularly given these catalysts are independent of geopolitical and macroeconomic crises.”
Lumos shares are up 1200% in the past year.
Amplia soars on pancreatic cancer trial results
Amplia (ASX:ATX) shares rose more than 100% this week after reporting four new confirmed responses (CRs) from its combination phase Ib/IIa pancreatic cancer trial Accent.
The fresh data resulted from an independent analysis, bringing the total CRs to five. A CR means all signs of cancer have disappeared for two months or more.
The Accent patients received a 400-milligram dose of Amplia’s candidate narmafotinib, combined with the chemotherapy standard of care.
With 64 patients enrolled Amplia CEO and managing director Dr Chris Burns said the five complete responders represented an “unprecedented” 7.8% response rate, providing “new hope for patients with this very aggressive cancer”.
The analysis also uncovered an additional partial response, taking the overall response rate to 23 patients (35%).
Overall survival has increased to 11.1 months, a two-month improvement on that achieved with chemo alone in a benchmark study.
Amplia expects the study to complete in the September 2026 quarter and has been selected to present trial data at the American Association of Cancer Research’s annual conference in San Diego next month.
“It is a major milestone for the company with pancreatic cancer a very high bar to jump over and what they’ve achieved is fabulous,” Power said.
“It is another great result for the sector.”
Strong back-to-back announcements for Blinklab
Blinklab (ASX:BB1) had two positive announcements this week, including selection for Morocco’s nationwide, government funded autism screening program and commencement of enrolment for its pivotal study.
Under a multi ministry national framework endorsed by King Mohammed VI, BB1’s Dx1 smartphone based screening tool will be deployed across Morocco for early autism screening from 18 months of age.
The program targets a large national public health need, with ~600,000 births annually in Morocco and ~400,000 people in the country living with autism.
Importantly, all implementation and rollout costs will be funded by the Moroccan government and the Foundation Mohammed V Solidarity, while BB1 retains ownership of all generated data.
“Morocco is a major endorsement and read-through around how the test will work in real-world situations,” Power said.
Blinklab has also kicked off enrolment of a pivotal trial of Dx1 to support US FDA 501(k) clearance.
The double-blinded, multi-centre designed study is across 10 leading US institutions with recruitment guided at ~8 months and FDA submission by end of CY26.
“The major key item going forward remains the pivotal study which is now live so recruitment pace will be the most closely watched KPI over the next two quarters,” Power said.
Mayo Clinic adopts 4DX’s ventilation prefusion tool
4D Medical (ASX:4DX) is up ~48% this week on news leading US hospital the Mayo Clinic will adopt its proprietary ventilation prefusion tool CT:VQ.
The Mayo Clinic becomes the sixth academic medical centre to deploy the technology since it gained FDA approval in September 2025.
CT:VQ has now been successfully rolled out at Stanford, Cleveland Clinic, UC San Diego Health, University of Chicago Medicine, and University of Miami.
4DX said Mayo would use CT:VQ for ventilation and perfusion analysis, enabling its clinical teams to build familiarity with the technology’s advanced diagnostic outputs, and to assess its application across a range of clinical use cases.
“It is a strong endorsement to have the Mayo Clinic, one of the top hospitals in the world, adopt CT:VQ,” Power said.
“They don’t adopt new technology lightly and so can obviously see a lot of merit in it.”
The company’s shares have been on a tear in the past year, up a staggering 1823%.
Power’s Powerplay: Echo IQ expands Mayo Clinic partnership
Echo IQ (ASX:EIQ) is Power’s stock of the week after rising more than 60% after also making a market announcement involving the Mayo Clinic.
Echo IQ said it was extending its deal supporting potential commercial rollout of its AI heart failure solution EchoSolv HF with the Mayo Foundation for Medical Education and Research, a non-profit entity of the Mayo Clinic.
The revised agreement allows Mayo Clinic to resell and distribute EchoSolv HF through the Mayo Clinic Platform’s Solutions Studio, providing access to Mayo hospitals, its wider health system, and more than 80 partner hospitals.
Power said importantly, the updated terms include improved commercial economics for EIQ and an automatic extension that could see the partnership run for up to six years.
EchoSolv HF uses artificial intelligence to analyse heart ultrasound scans (echocardiograms). The software automatically reviews images and measurements to help doctors detect heart failure.
The announcement follows a Mayo-led validation study of EchoSolv HF showing strong diagnostic performance.
Echo IQ has submitted an FDA application for 510(k) clearance for EchoSolv HF and is preparing for potential commercial deployment, positioning the company to tackle the large and under diagnosed US heart failure market.
“The key milestone the market is looking for is the FDA clearance for EchoSolv HF,” Power said.
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