FDA grants Emergency Use Authorization for Nanobiosym Gene-RADAR Zika diagnostic Test.

Courtesy: Nanobiosym

The US Food and Drug Administration has granted Emergency Use Authorization (EUA) to Nanobiosym's Gene-Radar Zika virus test. Emergency Use Authorization is only granted by FDA for Serious or life-threatening disease or condition to humans.

The WHO reports that Zika virus infection is prevalent and active in more than 60 countries including 40,000 people in the U.S. and its territories, that also includes at least 4,750 pregnant women. The greatest threat of Zika infection during pregnancy is the neurological deficit and damage to the unborn child in the form of microcephaly, decreased brain tissue and brain damage.

About one in 10 pregnant women with confirmed Zika infection had a fetus or baby with birth defects during 2016, said CDC during a press conference.

The Gene-RADAR®Zika Virus Test is a real-time reverse transcription polymerase chain reaction (rRT-PCR) assay for the qualitative detection of RNA from Zika virus in human serum and other authorized specimen types.

Gene-Radar technology by Nanobiosym Inc was the winner of the Nokia Sensing XCHALLENGE in 2013. Gene radar is a mobile diagnostic device that allows you to diagnose any disease with a genetic fingerprint in real-time with gold standard accuracy at a price a hundred times cheaper than anything else on the market today.

Zika testing is currently done by either a serological test or nucleic acid based tests, looking for DNA/RNA sequences. Serological testing yield high false-positive rates because of cross-reactivity with Zika-like viruses such as Dengue or Chikungunya. Gene-RADAR Zika test look precisely at the RNA sequence of the virus hence eliminating cross reactivity.

Essentially it is a point of care platform with nanochip test cassettes that can potentially run using a drop of sample, such as serum, blood, or saliva. The machine is the size of our palm, just like an iPad and weighs 3.5 pounds. The consumer can get the results back in an hour, instead of waiting for 1-2 days for other tests.  

The Gene-RADAR® Zika Virus Test is authorized for the qualitative detection of RNA from Zika virus in human serum from individuals in accordance to the CDC’s algorithm for Zika testing.

This test has not been FDA cleared, and is only authorized for use till such time that emergency circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, unless the authorization is terminated or revoked sooner.

"This FDA EUA represents a major milestone towards realizing our deeper vision: to decentralize, personalize, and mobilize the next generation of healthcare, much like cell phones transformed the telecommunications industry," said Dr. Anita Goel, M.D., Ph.D., Chairman and CEO of Nanobiosym and a Harvard-MIT trained physicist and physician. "The FDA's prompt feedback has accelerated our journey from winning the first XPRIZE for healthcare to bringing this new technology to patients and providers battling Zika on the front lines."

Clinical trials are already underway in Rwanda for detecting HIV viral load at point of care. Other application of Gene Radar technology is in fields of personalized medicine and cancer therapeutics.

The full text of FDA authorization could be accessed here.

             Nanobiosym’s XPRIZE winning-video about the Gene-Radar technology.

Ethicon receives FDA Clearance for its ECHELON CIRCULAR™ PowerEd Stapler.

CINCINNATI, April 19, 2017, Johnson & Johnson subsidiary Ethicon today received FDA 510(k) clearance for its Echelon circular powered stapler.

The ECHELON CIRCULAR™ Powered Stapler is equipped with 2 new technologies that enables it to reduce leaks without compromising circulation of the targeted organ.

Through proprietary Gripping Surface Technology, it is better able to hold the tissues with 33% reduction is tissue trauma. The second technology is 3D Stapling Technology which evenly distributes compression throughout the anastomosis.

A study showed 61% fewer leaks at the staple line compared to Medtronic's DST Series™ EEA™ Stapler.

"Ethicon is committed to reducing complications, which have a significant impact on healthcare costs and patient outcomes," says Tom O'Brien, Vice President, Global Endomechanical Platform Leader.

 "The ECHELON CIRCULAR™ Powered Stapler addresses these challenges by combining powered firing with two staple forming innovations that reduce leaks without compromising perfusion.”

The circular anastomosis is a very decisive step for the success of cancer surgery, that already have high risk of complications because of friability of the tissue. The most dreaded complication is leak which can lead to repeat surgery of the patient with high morbidity and insurance cost.

The circular stapler will specially improve results of bariatric and  colorectal, gastric and thoracic cancer surgeries.

Non-surgical, non invasive method to treat Breast Fibroadenoma by Focused Ultrasound System shows promising results.

courtesy: http://www.theraclion.com/

Theraclion announced results of a study evaluating the long-term assessment of breast fibroadenoma (benign tumor) volume reduction following treatment with the company’s Echopulse, a non-invasive treatment employing ultrasound-guided high-intensity focused ultrasound (HIFU).

Theraclion is a French company specializing in high-tech medical equipment using therapeutic ultrasound.

The study results were published online in the March 2017 issue of the Journal of Therapeutic Ultrasound.

20 patients with 26 Breast Fibroadenomas (BFAs) were recruited in the study. 19 BFAs received a single outpatient treatment session with Echopulse, while 7 fibroadenomas required a second session 6-9 months after the first initial session.

Patients were evaluated for Mean BFA volume, symptom relief and cosmetic appearance after the procedure.

All the patients were extremely satisfied by the treatment results. Mean BFA volume decreased by 77.32 percent after a single procedure and by 90.47 percent after two procedures at 24 months follow up.

Patients did not experience any serious side effect expect mild pain and tenderness at the treated site. Study did not report any regrowth of the tumor. They reported 100% satisfaction for the cosmetic appearance and 95% satisfaction for relieving the symptoms.

Breast fibroadenomas (FA) are the most prevalent benign tumours, accounting for up to 70% of benign breast lesions.

Currently, the accepted definitive treatment of FA is breast-conserving surgery which removes the FA entirely with a subsequent tissue volume defect and risk of complications as bleeding, seroma formation and chronic incisional pain.

“Our results show the long-term efficacy and safety of US-guided HIFU generated by Theraclion’s Echopulse in patients with breast fibroadenomas. US-guided HIFU is definitely an effective non-invasive alternative to surgery enabling more than 90 percent volume reduction without re-growth or serious adverse events” said Roussanka Kovatcheva M.D., professor of endocrinology at the University Hospital of Endocrinology of Sofia, Bulgaria, and Principal Investigator.

 Echopulse®, based on a unique ultrasound technology, combining focused ultrasound therapy (HIFU) and real-time ultrasound monitoring. This dual functionality allows precise, individualized, non-invasive and ambulatory treatment of breast adenofibromas and benign thyroid nodules.

The main components are: ● Visualization and processing unit (VTU) ● Integrated ultrasound system ● Arms and scanning motors ● Coupling and cooling system ● Patient motion detector ● Touch user interface.

Echopulse have already won the CE Mark for regulatory approval in the European Union for non-invasive ablation of breast fibroadenomas and thyroid nodules.

courtesy: http://www.theraclion.com/

The first patient in US was recently treated as a part of U.S. pivotal clinical trial evaluating the safety and efficacy of the company’s Echopulse. The trial is expected to enroll 100 patients across 4 sites in US and 1 site in Germany.

“High intensity focused ultrasound (HIFU) technology is exciting because it has the potential to provide patients with an alternative to surgery, avoiding a scar, with minimal interruption in their normal daily activity,” said principal investigator Dr. David Brenin. 

The full text of the article in Journal of Therapeutic Ultrasound can be accessed here.