Diagnosis
Proseek Bio raises AU$1.5m for ovarian cancer blood test

Australian startup Proseek Bio has raised AU$1.5m in an oversubscribed seed round to commercialise its ovarian cancer blood test.
With up to 80 per cent of surgeries for suspected ovarian cancer coming back benign, the company says better diagnostics are urgently needed.
Proseek Bio says its test is designed to support earlier and more precise clinical decision-making, while improving referral pathways and reducing unnecessary surgery.
OC-Triage is a blood-test-based ovarian cancer detection test that identifies specific glycoproteins, which are proteins that can indicate a future likelihood of ovarian cancer.
Proseek Bio says it could change how women are triaged for diagnostic surgery.
Founded by Michelle Hill, Proseek Bio says it has future applications beyond ovarian cancer, including endometriosis triage and other women’s health diagnostics.
The company said in a statement: “This funding will support the next stage of development for OC-Triage, our blood-based test for ovarian cancer, as we move toward clinical lab deployment and validation.”
Proseek Bio says women’s health has long been framed as “niche” or an “impact category” but says it is in fact one of the most mispriced opportunities in healthcare.
Ovarian cancer is one of the most lethal gynaecological cancers and more than 15,000 women in Australia undergo diagnostic surgery for ovarian cancer each year, with many cases diagnosed too late.
The five-year survival rate for ovarian cancer today is the same as the five-year survival rate for all cancers in 1975.
“We’re now seeing that shift: capital is beginning to catch up to the scale of both the clinical need and the commercial potential,” the company said.
“OC-Triage is designed to support earlier and more precise clinical decision-making, improving referral pathways and reducing unnecessary or delayed surgery.”
Proseek Bio says it is now preparing to pursue a Series A raise focused on market entry, clinical studies and regulatory progression.
Diagnosis
FDA delays ruling on ‘game-changer’ breast cancer drug

The FDA has delayed approval of camizestrant while it reviews new analyses submitted by AstraZeneca after advisers voted against the breast cancer drug.
The US regulator had been considering whether to approve the oral treatment after a phase 3 switching study in a specific group of breast cancer patients.
Camizestrant is an oral SERD, or selective oestrogen receptor degrader. These drugs are designed to block and break down oestrogen receptors that can help some breast cancers grow.
AstraZeneca filed for approval based on the phase 3 Serena-6 trial, which tested a treatment-switching approach.
Patients in the study received an aromatase inhibitor and a CDK4/6 inhibitor. Aromatase inhibitors lower oestrogen levels, while CDK4/6 inhibitors are targeted cancer drugs that help slow cancer cell growth.
After detecting an ESR1 mutation, investigators switched the aromatase inhibitor to camizestrant.
An ESR1 mutation is a change in a gene linked to the oestrogen receptor. It can make some breast cancers less responsive to standard hormone treatments.
AstraZeneca said switching to camizestrant was linked to a 56 per cent increase in progression-free survival.
Progression-free survival measures how long a patient lives without their disease getting worse.
However, the FDA raised questions about the study design.
An FDA advisory committee later voted six to three that AstraZeneca had failed to show camizestrant provides a clinically meaningful benefit.
The vote was a setback for the company’s hopes of approval, although the FDA can go against advisory committee recommendations.
After the setback, AstraZeneca submitted additional analyses requested by the FDA.
The company said the analyses include data on circulating tumour DNA clearance linked to longer-term efficacy outcomes.
Circulating tumour DNA refers to fragments of genetic material from cancer cells that can be found in the blood.
AstraZeneca is expected to share the data next week at the American Society of Clinical Oncology annual meeting.
The FDA has now delayed its ruling while it reviews the additional information. AstraZeneca did not provide a new decision date.
Three-month delays are typical and, during the second Trump administration, have been common.
After budget cuts reduced its workforce, the FDA delayed rulings on assets including Bayer’s Lynkuet, Biohaven’s troriluzole and Sanofi’s tolebrutinib. The FDA reportedly blamed a “heavy workload and limited resources” for one delay.
The agency has continued to delay rulings this year, with Biogen, Savara and Travere Therapeutics among the companies to say the FDA has extended reviews of their drugs.
Like AstraZeneca, those three companies faced delays after submitting additional information that the agency needed time to review.
If the additional analyses address the regulator’s concerns, AstraZeneca could still secure approval for a drug it has estimated could generate peak sales of more than US$5bn.
Guggenheim Securities analysts recently described the Serena-6 study as “a limited commercial opportunity in our and [AstraZeneca’s] view”.
AstraZeneca is also running two adjuvant studies and a trial in a first-line setting as it seeks to position camizestrant across different stages of breast cancer care.
Adjuvant treatment is given after primary treatment, such as surgery, to reduce the risk of cancer returning. First-line treatment is the first therapy given for a disease.
Roche reported the failure of its rival oral SERD in first-line breast cancer in March, but AstraZeneca executives have argued that their trial designs and drug candidate are different.
Last week, Europe’s Committee for Medicinal Products for Human Use issued a positive opinion on camizestrant.
The drug is expected to be marketed as Etcamah in Europe.
Diagnosis
NHS urged to update website following renaming of PCOS
Diagnosis
Women unaware of gynaecological cancers

Only one per cent of women can name all five gynaecological cancers, new research suggests, as 21 women in the UK die every day of the diseases.
The report also found that 31 per cent of women have put off or avoided seeking medical advice for gynaecological symptoms.
It also found that 43 per cent of women invited for cervical screening said barriers had put them off attending, while 18 per cent of respondents aged 25 to 34 who had been invited had never attended.
The five main gynaecological cancers are womb, also called uterine, ovarian, cervical, vulval and vaginal cancer.
The Lady Garden Foundation said that, while progress has been made since the UK government’s 2022 Women’s Health Strategy aimed to improve gynaecological cancer care, significant challenges remain.
John Butler, medical director and trustee at the Lady Garden Foundation, said: “The fact that only one per cent of the population can name the diseases that directly affect half of us underscores a significant awareness gap, impacting individuals’ ability to recognise vital signs and symptoms or seek timely medical help.
“Addressing this isn’t just about awareness; it’s a critical public health priority. Our collective efforts are essential to ensure the latest commitments announced by this government translate into tangible change that saves lives.”
The report said key reasons for delaying medical advice included difficulty making appointments, embarrassment and, for cervical screening, fear of pain or previous bad experiences.
Women also reported challenges within healthcare interactions, including feeling “not taken seriously”, “dismissed” or “not believed” when seeking gynaecological advice.
Jenny Halpern Prince, chief executive and charity co-founder, said: “We frequently hear reports of women feeling ‘not taken seriously,’ ‘dismissed,’ or ‘not believed’ when seeking gynaecological advice.
“These experiences highlight crucial areas where we can improve patient support and trust within our healthcare system, ensuring women receive the empathetic and effective care they need.”
The Lady Garden Foundation said it aims to increase awareness of both the charity and the five gynaecological cancers.
It also aims to serve as a primary entry point for reliable, stigma-free information, helping people understand their bodies, recognise symptoms and overcome barriers to accessing care.
Its Silent No More Garden was unveiled at the RHS Chelsea Flower Show 2026. Designed by Darren Hawkes, the garden serves as a national call to action, using five sculptures to spark conversations, break long-standing taboos and encourage open dialogue about symptoms and preventative care.
Butler said: “Continued focus and collaborative action are essential to progress.
“The ongoing commitment from the government, alongside societal efforts to break down taboos surrounding gynaecological health, are crucial.
“The Lady Garden Foundation is dedicated to being a beacon of information and support, empowering women with the knowledge they need. We urge everyone to learn the signs, speak up, and help us save lives.”
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