Ultimately, a partnering deal could be structured in several ways but they typically include up-front fees, milestones and sales royalties. INOVIQ may later seek FDA marketing approval, either under the 510(k) ‘predicate device’ route, or the de novo path for novel, low-medium risk devices. “That means we will have a test with a quality clinical data package that we can hand over to a lab partner to offer tests for sale to the market, potentially by the end of the year” Hinch says. This approach does not require US Food and Drug Administration (FDA) approval, enabling the test to be market ready earlier. The likely gambit is to sell the kits first as a laboratory-developed test, partnering with large pathology groups such as Sonic Healthcare, Quest Diagnostics or Labcorp. Hinch says INOVIQ’s commercialisation strategy is initially focused on the US market, with several options available. INOVIQ’s blood test thus could potentially serve as an adjunct to mammography.ĭiscomfort aside, mammograms are also less effective for women with ‘dense’ breast tissue, as the tumours do not show up well on the imaging. She notes there are 119 million women in the key markets of Europe, the UK, the US and Australia aged between 50-80 and thus eligible for a screening test.īut fewer than 70 per cent of eligible women undergo screening mammograms, often because they are uncomfortable. Hinch cites a $US4.2 billion ($6.1 billion) market for breast cancer diagnostics, which recently overtook lung cancer as the most common cancer. While the SubB2M platform is applicable to multiple solid cancer types, INOVIQ’s near-term commercialisation strategy revolves around advancing the blood-based assay as a monitoring tool for breast and ovarian cancers. Now, the company is planning a further study with key opinion leaders (clinicians) in the US using samples collected from women previously diagnosed with breast cancer during and after treatment. INOVIQ chief scientific officer Dr Greg Rice says there is a clear unmet need for better monitoring of breast cancer treatment response and earlier detection of recurrence. The false positives for SubB2M were five per cent lower than the commercial test across all cancer stages, while false negatives were 44 per cent lower. In part, the trial compared SubB2M/CA15-3 with an existing leading CA15-3 test. The independent study showed the SubB2M/CA15-3 assay improved the performance of a leading CA15-3 test routinely used for breast cancer monitoring.īased on 483 blood samples, the study showed an 81 per cent sensitivity (the ability to detect the tumours) and a 93 per cent specificity (avoiding false positive results). Licensed from the University of Adelaide and Griffith University in 2020, SubB2M is an engineered protein that binds to a pan-cancer biomarker called Neu5Gc, a sugar found on cancer cells. On June 27 this year INOVIQ shares soared more than 40 per cent after the company reported “outstanding” results from its watershed trial of its SubB2M/CA15-3 test, in relation to breast cancer. In late 2021 the company was renamed INOVIQ, which means ‘intelligent innovation’. INOVIQ was formed from the mid 2020 merger of the ASX-listed BARD1 Life Sciences and Sienna Cancer Diagnostics. INOVIQ contends that current diagnostic tests need improvement, presenting a clear opportunity to improve both screening of general populations and monitoring of previously diagnosed patients. The first indication slated for near-term commercialisation is breast cancer monitoring, with a product expected to be “market ready” for a partnership with one or more big-name pathology companies by the end of 2023.Īn ovarian cancer screening diagnostic is also in sight. “We have a broad diagnostics pipeline in development across a number of indications for cancer,” says INOVIQ chief executive Dr Leearne Hinch. When it comes to cancer diagnostics, the ‘tried and trusted’ methods are often not the best ones, but merely the techniques clinicians are familiar with.įor the ASX-listed INOVIQ (ASX:IIQ), the field is ripe for disruption and the company is wasting no time progressing its precision diagnostics based on two separate platform technologies – SubB2M and EXO-NET.
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