• Lumos soars after US FDA approval for FebriDx rapid, point-of-care test
  • Emyria will buy the Pax Centre for $1.7 million following psychedelic medicine law changes in Australia
  • Rhythm Biosciences establishes UK subsidiary as part of strategy for ColoSTAT entry into key market


Lumos soars 327pc today after US FDA approval

Lumos Diagnostics (ASX:LDX) is up 327% today after receiving US Food and Drug Administration (FDA) approval to market its FebriDx rapid, point-of-care test in the US, which could see a reduction in antibiotic use – a key concern of health professionals globally as antibiotic-resistant bacteria continue to rise.

The clearance allows FebriDx to be marketed in the US for use by healthcare professionals as an aid in the diagnosis of bacterial acute respiratory infection and differentiation from non-bacterial etiology in patients presenting in urgent care or emergency care settings.

LDX said FebriDx is intended to be used in conjunction with clinical signs and symptoms, including other clinical and laboratory findings, to evaluate patients for acute respiratory infection.

FebriDx is already registered in the UK, Europe, Canada, UAE, Brazil, Turkey, Pakistan, Singapore, Malaysia and Australia. It is designed to reduced the inappropriate and unnecessary prescribing of antibiotics,  recognised as a significant contributing factor to the growing global emergence of antimicrobial resistant (AMR) strains of bacterial pathogens.

Despite acute respiratory infections being predominantly viral in origin, they are the most common diagnosis for which antibiotics are prescribed and up to 40% of these prescriptions are considered unnecessary.

As a consequence, one of the core elements of the Centers for Disease Control and Prevention (CDC) Outpatient Antibiotic Stewardship program is to improve antibiotic prescribing by clinicians and their use in patients so that antibiotics are only used when needed.


Emyria buys Pax Centre as Aussie psychedelics laws change

Emyria (ASX:EMD) was up 4% in morning trade after announcing it will buy the Pax Centre for $1.7 million payable in a combination of shares (76%) and cash (24%).

The Pax Centre is a leading multidisciplinary psychological trauma care service, serving more than 4,000 clients using a comprehensive offering of conventional and emerging therapies.

It currently supports 20 clinicians across psychiatry, mental health nursing, clinical psychology, counseling, social work, occupational therapy and chiropractic care, generating more than $2.6 million of annual billings and has established strong relationships with referrers and major health payers.

EMD is developing psychotherapy treatments using MDMA and psilocybin.  From July 1 Australia has become the first country to allow psychiatrists to prescribe certain psychedelic substances to patients with depression or post-traumatic stress disorder.

The company said along with the Pax Centre it is already well advanced to deliver psychedelic-assisted therapy having:

● Secure supply of patient-ready MDMA
● Trained team of therapists and clinicians
● Ethics-approved care protocol for MDMA-assisted therapy
● Established an advanced patient data registry

EMD and the Pax Centre are developing care models for psilocybin-assisted therapy for treatment-resistant depression as well as additional clinical trial protocols to broaden and expand the knowledge of how these new interventions work for additional indications.


Rhythm established UK subsidiary as plans market entry

Cancer diagnostics technology companyRhythm Biosciences (ASX:RHY) has progressed its market entry strategy for ColoSTAT in the UK with the establishment of a 100% fully owned UK Subsidiary.

The ColoSTAT Test-Kit is Rhythm Bioscience’s simple blood test for the detection of colorectal cancer.

RHY said Rhythm Biosciences UK Limited will assist in the importation and distribution channels of ColoSTAT into the UK and other parts of Europe with Otto Buttula and Paul Smith as directors of the company.

“Having a local presence in the UK will provide the parent company the opportunity to engage directly with local customers and direct involvement with the supply chain requirements of ColoSTAT,” RHY said in an announcement. 

The company said the UK market including England, Scotland, Wales, and Northern Ireland has a population of  ~10.7 million people in the current addressable Colorectal Cancer (CRC) screening market aged from 60 to 74.

The UK utilises the Faecal Immunochemical Test (FIT) as a screening methodology with an approximate participation rate of 67%.

Mach 7 gets US contract for veterans health

Health imaging company Mach7 Technologies (ASX:M7T) has announced a multi-million contract to participate in the Veterans Health Administration’s (VHA’s) National Teleradiology Program (NTP) in the US.

As part of the contract M7T will provide its VNA and eUnity Enterprise Diagnostic Viewer solutions which will help form the core of the NTP NextGen PACS architecture.

The VHA NTP is Veterans Affairs’ in-house teleradiology service which has been providing 24×7 service to VHA facilities for more than a  decade.

M7T said NTP supports 125 sites across all 18 Veterans Integrated Services Networks (VISNs) and is projected to interpret between 1 and 1.5 million studies annually.

M7T said NTP seeks a best of breed, next generation PACS that is designed, deployed and optimised for its teleradiology workflow and reading environment.

The NextGen PACS program involves two major phases with Phase I seeing M7T’s VNA and eUnity viewer solutions form the core of NTP’s NextGen PACS, with a potential total contract value (TCV) of $11.7 million with a 12-month implementation/professional service fee period then a fee per study subscription licence over a three year term.

The company said Phase II is contingent upon a number of success factors in Phase I and involves expansion into Veterans Affairs’ hospital network to support up to seven VISNs with migration, integration and software representing additional potential TCV of $47.9 million over a five-year term.

“As a veteran myself, I’m proud that Mach7 has been given the honour to do its part in supporting our veterans,” M7T CEO Mike Lampron said.

“Beyond the incredible privilege to serve this very special part of our community, this opportunity will allow us to expand our footprint into the US public health sector.”


The LDX, EMD, RHY & M7T share price today: