• INOVIQ reports good findings from feasibility study
  • Mayne Pharma launches a unique oral contraceptive in the Aussie market
  • Genetic Signatures has US FDA in its mind

Diagnostics and exosome specialist INOVIQ (ASX:IIQ) – formerly called Bard1 Life Sciences – announced that a feasibility study to evaluate the use of SubB2M has been successfully completed.

SubB2M is an engineered protein that binds to a unique sugar molecule called Neu5Gc, which is only present in human cancers. The exclusive worldwide licence for SubB2M is held by INOVIQ.

In the feasibility study just completed, the use of SubB2M was evaluated as an immunohistochemistry (tissue‐based test) reagent to aid in discriminating between benign skin lesions, malignant and metastatic melanoma.

The study evaluated 144 tissue samples (13 normal, 17 benign, 92 malignant and 22 metastatic).

Results show that cells staining positive for SubB2M approached 100% in malignant and metastatic tissues, and were significantly greater when compared to benign skin lesions.

These cell staining scores were independently performed by Dr Ian Katz, a senior pathologist at Southern Sun Pathology, and senior lecturer at the School of Clinical Medicine, University of Queensland.

The findings support INOVIQ’s SubB2M diagnostics program, which is developing blood tests for monitoring of breast, ovarian and other cancers.

“Having successfully completed this SubB2M IHC feasibility study, the company intends to seek interest from diagnostic companies and pathology laboratories to sublicence SubB2M for the development of IHC tissue‐based tests,” said INOVIQ CEO, Dr Leearne Hinch.

INOVIQ has a portfolio of patented products, which includes the recent patent granting of the SubB2M technology in the US in early July.

The SubB2M technology was already granted an Australian patent in May.

INOVIQ says it wants to capture the multi-product pipeline for detection and monitoring of breast, ovarian and other cancers – targeting a a potential total addressable market of US$15 billion globally.


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Mayne Pharma launches unique oral contraceptive Down Under

Mayne Pharma (ASX:MYX) announced that NEXTSTELLIS, a first-of-its kind oral contraceptive with a novel estrogen, is now available in Australia.

NEXTSTELLIS was approved by the Therapeutic Goods Administration (TGA) in November, and is the first and only contraceptive pill containing a new low impact estrogen, estetrol (E4), and a progestin, drospirenone.

E4 is derived from a plant source, and is a natural estrogen produced by the human body during pregnancy.

NEXTSTELLIS will compete in the Australian combined (estrogen plus progestin) oral contraceptive market which is valued at $60 million.

Combined oral contraceptives continue to be the most common method of contraception, with nearly 1 million Australian women using them.


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Genetic Signatures targets US FDA submission

The molecular diagnostics company announced it has completed recruitment for the clinical trial of its 3base EasyScreen Enteric Protozoan Diagnostic Kit in the US.

Genetic Signatures (ASX:GSS) says this is an essential step to support an application to the FDA, with submission of a 510(k) application planned during the fourth quarter of this year.

Once cleared, Genetic Signatures will market this syndromic PCR test to the US market.

The EasyScreen diagnostic kit uses GSS’ proprietary 3base technology to analyse the genetic profiles of protozoan pathogens.

Results from EasyScreen tests can be available within hours, compared with days or weeks for culture-based methods, and are typically able to identify more infections than traditional methods.


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