ASX Health Stocks: Resapp gains on India COVID-19 trial, Atomo to supply HIV self-test in Australia
Health & Biotech
Health & Biotech
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The ASX 200 Health Index (XHJ) is up by 0.35% at the time of writing, compared to the broader index which is higher by 0.25%.
Headlining the sector today are two diagnostic companies.
Respiratory disease specialist, ResApp Health (ASX:RAP), announced that its Indian COVID-19 clinical study has completed recruitment of over 100 COVID-19 positive patients ahead of time.
Given the fast recruitment, the study has now been expanded to 200 positive cases and is expected to complete recruitment by the end of November.
The increase in case numbers will provide for greater robustness and certainty in evaluating COVID-19 candidates, to give ResApp the highest chance of developing a truly accurate algorithm for COVID-19 screening, RAP said.
ResApp is the only company that has commercialised a regulatory-approved smartphone application that uses cough sounds to instantly diagnose acute respiratory disease.
It has an extensive library of cough sounds and clinical diagnoses from patients with other respiratory diseases collected even prior to COVID-19.
Another diagnostic specialist, Atomo Diagnostics (ASX:AT1), said it can now supply its HIV self-test to any business or institution (including a pharmacy) that employs or engages individuals who have received appropriate training.
This comes after the Therapeutic Goods Administration (TGA) broadened the organisations to whom the HIV self-test can be supplied.
The new rule has effectively changed the conditions imposed on the entry of the Atomo HIV self-test in the Australian Register of Therapeutic Goods (ARTG).
Atomo manufactures and supplies the only HIV self-test available in Australia.
The mental health tech company said that its SADB (Sleep Analysis of Depressive Burden) algorithm development, known as MEB-001, is now entering validation trials of the study.
Data analysis has so far demonstrated high levels of performance inaccuracy, sensitivity, and specificity relative to the current best practice standard for measurement of depression in the US, PHQ- 9.
As a result of the success of the study, planning has now begun for the development of the cloud-based software medical device platform known as MEB-001SaMD, as it seeks FDA approval.
Starpharma has received its first orders of approximately 100,000 units of VIRALEZE antiviral nasal spray to Vietnam.
The company is also finalising an ongoing distribution agreement for VIRALEZE in Vietnam, which will allow subsequent larger orders and ongoing supply.
Vietnam, with a population of almost 100 million people, is currently experiencing a significant Delta outbreak with only 20 per cent of its population fully vaccinated.
The company said it has submitted a number of changes to the Human Research Ethics Committee for the PARA-OA-008 clinical trial protocol.
The amendments include the initiation of an additional site in NSW, a once weekly dosing regimen and extension of the follow-up from 6 to 12 months.
The study is investigating changes in synovial fluid biomarkers associated with pain, inflammation and disease progression in patients with knee osteoarthritis.
Nyrada Inc (ASX:NYR)
The NYR stock price has gained over 12% as the company updated the market with its quarterly highlights, including progresses in its cholesterol-lowering program and brain injury program.
The sleep-related breathing disorder specialist reported revenue of $15.6 million for Q1 FY22, up 14% vs the previous corresponding period, with total patients treated worldwide now exceeding 650,000.