FDA grants breakthrough designation to urine-based liquid biopsy for prostate cancer - miR Sentinel PCC4 Assay

 The miR Sentinel PCC4 Assay is a non-invasive test that has achieved sensitivity and specificity rates above 90% for both detecting and classifying prostate tumors.

The FDA has granted a breakthrough device designation to the miR Sentinel PCC4 Assay (miR Sentinel Prostate Test), a urine-based, non-invasive test that can be used to diagnose, classify, and monitor prostate cancer.1

Initial data validating the efficacy of the assay were previously published in the Journal of Urology.2 The findings showed sensitivity and specificity rates of greater than 90% for both detecting prostate tumors and classifying them as intermediate or high risk.

The breakthrough designation will expedite the development and regulatory review of the miR Sentinel PCC4 assay.

"We are highly appreciative that the FDA's breakthrough designation process provided miR Scientific with invaluable feedback, which we have incorporated into our current clinical prospective studies to support our full marketing authorization plan," Sam Salman, chairman and CEO of miR Scientific, stated in a press release.1

"Receiving this designation achieves another important milestone in the development of our novel and ground-breaking technology. We believe that the accuracy and non-invasive feature of our award-winning technology will impact the lives of millions of men and forever positively change the standard of care for urological cancers," added Salman.

The miR Sentinel PCC4 Assay involves interrogating small noncoding RNAs (sncRNAs) that have been extracted from urinary exosomes. The interrogation of the sncRNAs is done through a high-throughput real-time PCR–based platform. Proprietary selection and classification algorithms are used to analyze the interrogated sncRNAs.

In the study, the investigators extracted sncRNAs from urinary exosomes of the 235 enrolled individuals. The sncRNAs were interrogated on miR 4.0 microarrays. According to the researchers, “Using proprietary selection and classification algorithms, informative sncRNAs were selected to customize an interrogation OpenArray platform that forms the basis of the tests.”2 Validation of the tests was done using a case-control sample that consisted of 1436 individuals.

The Sentinel Prostate Test showed a sensitivity rate of 94% and a specificity rate of 92% in detecting prostate cancer. The sensitivity and specificity rates were 93% and 90%, respectively, for the prediction of Grade Group ≥2 cancer, and, the corresponding rates were 94% and 96%, respectively, for the prediction of Grade Group ≥3 cancer.

In an accompanying editorial simultaneously published in the Journal of Urology,3 Brian Helfand, MD, division of urology, NorthShore University HealthSystem, Evanston, Illinois, discussed the significance of the findings. 

“Urologists are all too familiar with the inherent limitations of prostate cancer screening. As such, novel biomarker tests that can better distinguish both prostate cancer from indolent disease and high-grade from indolent tumors are greatly needed,” wrote Helfand.

It is flu season once again ...

A shortage in Tamiflu

The high volume of Tamiflu prescriptions at this point in the season has resulted in a shortage of the medication. While the FDA has not yet confirmed this shortage, doctors and pharmacists in both urban and rural areas are reporting difficulty in accessing Tamiflu for their patients.

Those unable to access Tamiflu this year do have other options. Besides Tamiflu, there are two other influenza medications: Relenza and Rapivab. Both are considered just as effective as Tamiflu and may be easier to access this year. For more information on these medications, see our post here. 

Over the counter medications can also help ease symptoms. Read here for more details on over the counter flu medications.

Is it effective?

Tamiflu is sometimes treated as a cure for all cases of the flu, but recent studies call this reputation into question. According to a study-of-studies, or meta-analysis, performed by CochraneResearch of 46 studies involving more than 24,000 people, Tamiflu may provide a much smaller benefit than expected. At best, the analysis found that Tamiflu may only help patients recover one day faster, and may not reduce the number of flu-related complications, like pneumonia. Additionally, it may only reduce the risk of getting sick by 55%. At over $50 per prescription for generic oseltamivir, for some, the benefits may not outweigh the cost.

While these findings don’t negate the use of Tamiflu, they may indicate that it is less protective than we had previously thought.

Human trials of a Zika vaccine just approved

21-June-2016
The US Food and Drug Administration (FDA) has approved the first human tests of an experimental Zika virus vaccine, the makers of the drug announced on Monday.
Called GLS–5700, the medication will be used in a clinical trial involving 40 healthy people, and represents the first major step towards ultimately immunizing people against Zika – which was declared a global public health emergency by the World Health Organization (WHO) in February.
GLS–5700 works by stimulating the body's immune system to defend itself against Zika. Synthetic fragments of viral DNA are injected into the skin, prompting the immune system's T cells to generate antibodies to fight the infection.
It's worth pointing out that just because GLS–5700 has reached human testing, there's no guarantee it will turn out to safely immunize people against Zika. The vaccine has been tested successfully in small and large animal models, but clinical trials in humans could take several years to demonstrate that the treatment is safe, and there's no guarantee it will ultimately prove effective or make it through subsequent testing phases.
GLS–5700 isn't the only Zika vaccine candidate currently in development.It has been reported that at least one company in India and one in France are expected to begin human trials later this year.