Posted on

STILL EARLY DAYS FOR LIQUID BIOPSY

MDDnowReutersSTILL EARLY DAYS FOR LIQUID BIOPSY

Multi-billion market opportunity draws variety of approaches from congested field of companies

http://www.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=92613

By Amanda Pedersen

Tuesday, April 26, 2016

Analysts and market researchers often try to put a monetary value on an emerging sector but estimating the market potential of a new technology category is far from an exact science. The liquid biopsy market is a prime example of that challenge.

“There are a variety of numbers that have been thrown out by a variety of different sources and I think that’s really all to say it’s an embryonic area and people don’t really know where this is going to go,” Gene Walther, CEO of Vortex Biosciences Inc., told Medical Device Daily. “Some of the big firms, J.P. Morgan and Piper Jaffray have indicated that it’s a $22 billion to $32 billion market opportunity, but many of those are looking at the clinical applications and not really including or incorporating what the research potential is.”

Walther said the research applications in this space alone represents a market anywhere between $1 billion to $8 billion. Vortex, of Menlo Park, Calif., is among the many players that have seen the opportunity and potential of the fairly congested liquid biopsy field.

Suffice is to say the market for liquid-based cancer tests will eventually grow to become a multi-billion opportunity and there will be plenty of pie slices to go around. But what really makes this an interesting space is the variety of approaches liquid biopsy companies are taking with the technology and the array of purposes for which these various tests will be used.

This week, in a two-part series, Medical Device Daily is exploring both the potential clinical and business opportunities this young but fast-growing market has to offer.

Looking at the liquid biopsy space from the broadest viewpoint, it can be segregated by the type of liquid being collected: urine or blood. So far San Diego-based Trovagene Inc. appears to be the lone wolf in the urine-based liquid biopsy category while the majority of companies are duking it out for leadership on the blood-based side.

Zooming in on the blood-based sector, the market can be divided into at least four different categories based on the specific components of the blood the test is designed to capture — circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), nucleosomes and exosomal RNA — and some of those categories can be further split into subcategories, such as whether or not the test is used for clinical or research purposes and, if it is used in the clinic, is it being used to find cancer (detection) or to follow it (monitoring).

“A lot that work still needs to be done. I think the biology of cancer and really how we can maximize the use of liquid biopsies, whether it be the application of circulating tumor cells or circulating tumor DNA and how they can work and compliment each other still needs to be proven,” Walther said.

Finding the needle in a haystack

Vortex is trying to differentiate itself by not using any kind of labels such as magnetic beads or stains, but rather isolating intact CTCs to allow the end user to perform a variety of different types of analysis, such as next generation sequencing, growing the cells to be able to study them further or looking at the proteomics and the way the gene expressions are happening within the isolated tumor cells.

“By having these intact CTCs you’re able to do much more of a thorough and broad analysis on those cells,” Walther said. “Within that space what we think differentiates our technology and our approach is a higher purity.”

Vortex has developed a fully automated benchtop system called the Vtx-1 for collecting intact CTCs using microfluidic technology. Inside the Vtx-1 chip, unlabeled CTCs in whole blood are trapped in microsale vortices while smaller red and white blood cells pass through. After selectively trapping into the microfluidic chamber, CTCs can be flushed and collected into a variety of containers for downstream analysis.

This technique is easier said than done though. Walther explained that each blood sample contains billions of very small red cells and millions of slightly larger white cells and a much smaller number, roughly one to 500, of CTCs. It’s a lot like looking for a needle in a haystack, he said, and being able to isolate the CTCs from those red and white blood cells is a tremendous challenge. In the end, the Vtx-1 is expected to capture the CTCs in a sample of blood and only a minimal amount of white blood cells.

You can get different varieties of viagra pfizer prix here easily and at a very affordable price. In a cheap women viagra 1997 randomized clinical trial, researchers found that chiropractic is effective on neck pain. Such ladies get a good remedy through the pills of this medicine.The medicine again promotes the speedy flow of blood in the women gentile area and help in making the area sensitive toward slight activity. tadalafil generic viagra NF Cure capsule acts internally and rejuvenates the overall health of person. cialis 10 mg continue reading that “I would never propose that we’re going to be 100 percent pure because you’ve got cell overlaps, you’ve got small tumor cells, you’ve got large white blood cells,” Walther said.

He said the technology is able to clear the red blood cells fairly well but there are some residual white cells that will be left in with the CTCs. “When you compare it to other technologies, at least based on published reports, we believe that the purity of our technology is actually a high differentiation from the other technologies that are available,” he said. “The market is going to want to see some direct comparisons in the not-too-distant future to be able to actually differentiate the technologies.”

Walther said the company has generated a fair amount of interest from research labs and clinical labs but Vortex also has received notable attention from pharmaceutical companies because the ability to isolate CTCs and grow them presents an opportunity to test the effectiveness of various compounds they may have in development. That’s a distinct advantage over tests that use ctDNA, he said, because ctDNA shows fragments of DNA from cells that have been killed, in theory, by the treatments the patients are on.

“What it doesn’t capture is the residual cancer that may have become resistant to that drug or that may not respond to that drug,” Walther said. “It may be more effective in being able to determine cocktails of drugs. If you think about the approach that the pharma industry has taken fighting Aids, it’s a cocktail approach, it’s not a single drug.”

The company recently did a soft launch of the system to introduce it to researchers and plans to do a formal product launch early next year.

nucleosomes are the haystack

Volitionrx Limited, of Namur, Belgium, is trying to set itself apart in this crowded market by focusing on a cost-effective platform designed to work in multiple cancers and by looking at nucleosomes in circulation. The company received CE mark approval in April for two blood-based assays for the detection of colorectal cancer. The biomarker assays, Nuqv001 and Nuqt003 are designed to analyze fragments of nucleosomes circulating within the blood for the presence of cancer signatures. Volitionrx plans to launch a panel test for the detection of colorectal cancer for clinical use in Europe toward the end of the year.

“We’re not looking for the needle. The nucleosomes are the haystack,” CEO Cameron Reynolds told Medical Device Daily at J.P. Morgan’s health care conference in January.

Reynolds said his company’s test is so low cost that Volitionrx only spent about $18 million over five years to develop the assay because it is using a “very old platform” that is easy to roll out worldwide. He said if the company delivers what it intends to, which is a low-cost, accurate diagnostic screening blood test, it will “change everything.”

“People say blood tests are the answer and they really are,” Reynolds said. “But I think anyone in our business has to accept nothing has worked. Everyone’s very skeptical because the last big break through was 35 years ago with PSA for prostate cancer.”

For example, Reynolds said, thousands of papers have been published but not one has been launched and widely adopted as a screening test. Other companies are also looking at nucleosomes, he said, but he said those competitors are actually looking at the DNA wrapped around the nucleosomes.

Don’t dismiss RNA

Exosome Diagnostics Inc. is taking a very different approach in the liquid biopsy field with its test designed to isolate and analyze exosomal RNA from a blood sample. The plasma-based diagnostic is intended to enable real-time detection of EML4-ALK mutations in patients with non-small cell lung cancer (NSCLC). The company said its platform provides a more direct and sensitive method of detecting fusions such as EML4-ALK, compared to cell free DNA alone. EML4-ALK is a gene fusion found in a subset of patients with NSCLC and predicts response to ALK inhibitor therapies.

John Boyce, CEO of the Cambridge, Mass.-based company, told Medical Device Daily in February that DNA alone is not enough to solve the puzzle. Just like there will never be one drug that can cure cancer by itself, oncology doctors need more than one liquid biopsy tool to treat and monitor their patients, Boyce said. If they only measure the cell-free DNA to see if a particular drug is working, all they know is what is dying in the blood.

“And that’s good, you can see what’s dying, you can see that you’re killing off the [tumor cells] but you’re not able to see what’s on the rise,” Boyce said. “So it’s natural selection. As soon as you kill one of them off there’s a new bully on the block in the tumor.”

That’s something that can’t be identified with cell-free DNA, he said. “The only way you can do that is looking at the RNA and the only way that you can get the RNA from the blood is from exosomes because RNA doesn’t float around in the blood freely.”

In the end, Boyce said, oncologists need to see both what is dying and what is living in the blood.

Published  April 26, 2016

Posted on

Light-based acne treatment goes global via license/JV agreement

THE DAILY MEDICAL TECHNOLOGY NEWS SOURCE 

Light-based acne treatment goes global via  license/JV agreement

By Amanda Pedersen, Senior Staff Writer

MONDAY, JULY 21 , 2014

The dermatology market just got a little bit brighter. 

Klox Technologies (Laval, Quebec), a company developing a light-based technology for acne treatment and other dermatology indications, has gained global market access through a worldwide license and joint venture agreement with Leo Pharma (Ballerup, Denmark).

Leo Pharma will help Klox to further develop and commercialize its Biophotonic technology platform in dermatology, which includes a CE-marked treatment for moderate to severe acne. The worldwide agreement excludes Canada, where Klox already has a partner that launched the device a few months back. Leo Pharma has also agreed to make an equity investment in Klox. The deal paves the way for Leo Pharma’s first medical device therapy and first global market entry in acne.

The non-abrasive, non-thermal device comprises a multi- LED light used in conjunction with a photoactivable converter gel. It works by targeting the underlying problems that lead to acne vulgaris, as well as stimulating collagen synthesis and healing in traumatized skin, thereby promoting healing in the epidermis and deeper in the dermis, Klox said. Completed within a 15-minute treatment cycle including preparation, treatment requires twice-weekly application over six weeks. In clinical trials, the acne Biophotonic system demonstrated highly statistically significant improvements in moderate to severe acne sufferers, Lise Hébert, president/CEO of Klox, told Medical Device Daily.

 

The way it works is the converter gel is applied to the area being treated, which is then illuminated by the lamp. The interactions that take place aid in the creation of an environment favoring repair.

 

“Within the field of dermatology, acne was something that we felt was indeed an unmet need,” Hébert said. “Yes, there are many products on the market, mostly topical or antibiotics, but in the case of severe acne very, very little innovation was going on.”

Other companies in the space would repackage or reformulate existing products, but there was no treatment on the horizon that would really be a game changer, Hébert said.

 
It prevents the early signs of aging such as wrinkles and age spots, and it also helps manage or reduce the symptoms of depression and boost cialis wholesale prices mood. 3. purchase viagra online Patients who are suffering from any allergic disease should avoid this medication. The famous tadalafil tablets prices was a hit in males treating sexual problems from loss of libido etc. Normal penile erectile needs a complex set of dynamic neural and also needs vascular interactions. prix viagra pfizer
She noted that the company designed its European trial based on FDA parameters and guidance so that the data could one day be useful in the U.S. as well. The trial enrolled moderate and severe acne patients, mostly teens and young adults.

 

“The surprise that we got, that was not necessarily predicted, was that the lens not only addresses the acne but has a favorable impact on scarring,” Hébert said. The trial also examined the persistence of the efficacy over a six-month period, she said, and of the patients that have met that six-month follow up, “not a single one reverted to baseline.”

 

Hébert said the partnership with Leo further validates the technology and its applicability in multiple therapeutic areas. She said the two companies will develop and commercialize Biophotonic therapies in dermatology with the intent of bringing patients efficacious products with a good safety profile.

 

“This deal also represents the completion of a significant step in Klox’s strategic roadmap aimed at achieving sustainable, commercial profitability in the short to medium term,” Hébert said. She added that the agreement with Leo also helps Klox focus resources on developing the company’s wound care program, which Klox plans to commercialize as early as the first half of 2015 in Europe.

 

Leo Pharma will be responsible for clinical and commercial activities, including manufacturing. Also, Leo has agreed to provide financial support for Klox R&D in dermatology. The financial terms were not disclosed but the companies noted that it includes a “significant upfront, as well as double-digit, escalating, tiered royalty rate based on product sales.”

 

Klox wanted a strategic partner like Leo because the dermatology market is very large and already has several large, successful companies, so to compete in the space would require a large sales force and a lot of marketing dollars, she said.

“Today, there is a significant unmet need for alternative acne therapies. With this technology, Leo Pharma aims at soon offering a new treatment solution that is non-invasive and effective. We hope it will enable patients to integrate acne therapy into their everyday lives and successfully manage their condition,” said Gitte Aabo, president/CEO of Leo Pharma. “By partnering with innovative companies like Klox, Leo Pharma aims to push the boundaries of dermatology care and deliver more treatment solutions that make a real difference to the lives of people with skin diseases.”

Hébert told MDD that the company’s goal is to initiate a trial in the U.S. in the very near term and also to launch into commercial activities in Europe because the product is already approved there. Also, she said, the two companies will start working on the next product in Klox’s technology platform. The company also expects to get approval in Europe this summer for the next indication of the technology, which will be wound healing. //

Posted on

BioDirection aims to rapidly identify head injury severity

NewCo on the Block

BioDirection aims to rapidly identify head injury severity

MONDAY, MARCH 26, 201 2

By AMANDA PEDERSEN

Medical Device Daily Senior Staff Writer

Every single day somebody somewhere hits their head. A child on the playground at school or in gym class. An athlete during practice or a competitive game. An elderly person falls. A soldier on the battle field faces the wrath of an IED blast.

The problem is, there is currently no good, fast way to distinguish a minor hit from a severe concussion. Symptoms may not appear for weeks or months after the injury occurs so even post-injury examinations are often inconclusive.

The founders of a new company, BioDirection(Tuscon, Arizona), has found a better way to provide early identification and medical intervention following a head injury. The privately-held company has developed the Tbit – a handheld device based on dual biomarker and

nanowire technology – designed to diagnose the severity of a head injury at the point of care and, potentially, at the point of injury.

And the test only takes about 60 seconds to analyze a single drop of blood taken within minutes of an injury. BioDirection anticipates launching the Tbit in 2013. “This is the absolute opportunity for us, for the first time, to do a biomarker review . . . from a point of care

device,” Brian McGlynn, president/CEO of BioDirection, told Medical Device Daily. He said that current assays that are used to assess the severity of a head injury can take anywhere from 90 minutes to three hours to deliver results and are “very expensive” and only analyze one biomarker protein at a time. BioDirection’s technology uses a drop of blood and is designed to detect two biomarker proteins known for brain injury.
The improper functioning of the germinal glands affects the whole life-current in an individual leading male problems like impotence (erectile dysfunction), sexual asthenia, low sperm count, general body weakness and impotence and loss of stamina and vigor. viagra pfizer 100mg Perhaps you’d like https://regencygrandenursing.com/index.php?option=com_gmapfp&view=gmapfp&tmpl=component&layout=item_carte&flag=1&id=1&Itemid=167 generic levitra from canada to access information on your smart phone or tablet. Let’s have a look at different health problems that can be cured https://regencygrandenursing.com/long-term-care/bariatric-care purchase viagra without prescription with the help of with Chelation therapy. If it is not possible because of financial problem or something specific to your situation canadian discount cialis then find out the best one.
“We have to find these people. We have to identify them at the point of injury – everyone agrees on that point,” McGlynn said.

McGlynn noted that the kids in sports, professional athletes, and even military service members who receive a head injury tend to want to continue on in the game or in their mission, especially if the only symptom they experience is a little dizziness or a headache. “If they actually get through the game and ultimately go into another game and receive another hit . . . it could be catastrophic,” he said. “The best thing we can do right now is identify that there is an portfolio will solidify our proprietary position in the field of brain injury management,” McGlynn said.

Interestingly, he noted that 13% of sports concussions happen during practice alone.

“We’re not trying to eliminate competitive sports . . .we just have to be able to identify the injuries because this allows them to go forward,” he said.

In addition to being a useful device for contact sports and military medicine, the Tbit would also be useful in ambulances for paramedics treating accident victims.

BioDirection recently signed an exclusive license agreement with Nanosys (Palo Alto, California), an advanced materials architect, for an extensive portfolio of Harvard University (Cambridge, Massachusetts) generated nanowire patents and patent applications. The agreement grants the company exclusive worldwide rights to use nanowires for biosensor applications in the field of brain injury detection and monitoring. The IP portfolio, invented by Charles Lieber, PhD, a pioneer in the field of nanowire technology, includes 11 issued U.S. patents, five pending applications and broad filing in key foreign jurisdictions. “The quality and depth of the licensed intellectual portfolio will solidify our proprietary position in the field of brain injury management,” McGlynn said.

The company has been self-funded to date, McGlynn said, and is in discussions with private and venture capital investors for some possible investments and some grants. Other companies and researchers have also recognized the need for a better assessment tool to manage head injuries. At last year’s Cleveland Clinic Medical Innovation Summit, a concussion management system was identified as third on the organization’s list of Top 10 medical innovations for 2012 (Medical Device Daily, Oct. 7, 2011).

The new concussion management system includes a special assessment tool that is used to establish an athlete’s baseline cognitive and motor skills at the beginning of his or her athletic season. This is the first tool that objectively and accurately assesses cognitive and motor function simultaneously, according to the Cleveland Clinic experts. During practice and games, the athletes use a special instrumented mouthguard dosimeter that records all hits to the head.

The mouthguard looks exactly like an ordinary sports model, the experts note, but it is able to monitor all the energy imparted by a blow to the head of any kind, recording and reporting this impact via Bluetooth technology in real time. Another effort reported on last year is a sideline visual test that effectively detected concussions in collegiate athletes last year, according to researchers from the Perelman School of Medicine at the University of Pennsylvania (Philadelphia).

The researchers reported that concussed athletes scored an average of 5.9 seconds slower (worse) than the best baseline scores in healthy controls on the timed test, in which athletes read a series of numbers on cards and are scored on time and accuracy (MDD, Sept. 2, 2011).

Posted on

GT answers FDA questions for LuViva PMA application

GT answers FDA questions for LuViva PMA application

http://www.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=76690

By AMANDA PEDERSEN

September 6, 2011

Medical Device Daily Senior Staff Writer

Guided Therapeutics (Norcross, Georgia), a developer of a rapid and painless testing platform that uses biophotonics for the early detection of disease, says it has answered all of FDA’s key questions regarding the company’s premarket approval (PMA) application for the LuViva Advanced Cervical Scan.

“We are pleased to provide the FDA with the additional information the agency requested and within the time period required to maintain the PMA application under active review,” said Mark Faupel, PhD, president/CEO of Guided Therapeutics. “The FDA will review our submission, we hope move forward with the PMA process and schedule a panel meeting date, although the agency has the option to ask for additional information.”

LuViva scans the cervix with light to identify cancer and pre-cancer painlessly and non-invasively, the company noted. Guided Therapeutics’ biophotonic technology is designed to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, LuViva does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly and painful unnecessary testing, the company said.

Faupel told Medical Device Daily that the sequence of events with FDA so far has followed a “normal” track. “There are a number of people at FDA involved in formulating questions both with regard to the clinical side of the clinical trial and technical side of the instrumentation,” he said. There were several questions the company had previously dealt with by submitting draft responses and the majority of those were accepted on what Faupel referred to as a “first round.” There was one question, however, that the agency asked for additional information on which Guided Therapeutics says has now been dealt with. He declined to say what that issue was for competitive reasons. Now the company just has to wait and see if and when a panel meeting is scheduled.

“It was a necessary and major step in getting us closer to that panel meeting,” Faupel said.

The company submitted its PMA application about a year ago (Medical Device Daily, Sept. 28, 2010). In its pivotal trial, more than 1,600 women at risk for cervical disease were tested with the device. According to the company, the device detected cervical disease up to two years sooner than a Pap test, HPV test, colposcopy or biopsy and it detected 86.3% of cervical disease cases that had been missed by these other methods. Also, the device would have reduced the number of unnecessary biopsies by about 40%.
Another embarrassing problem for males generic cialis from canada is nocturnal emission. Lately, more radical order free viagra materials have been used in adult toys. We are talking about medication that is not affordable to you, an online Canadian drugstore cheap viagra without prescription may be able to supply the medication at a descent discounted price. This is a online viagra frankkrauseautomotive.com guarantee that what is shipped to the buyer is the correct product and it will work as well as the brand.
The fact that the questioning phase of the process was so involved simply reflects that the company has a “fairly high visibility product with a lot of reviewers” involved, Faupel said. “They are more involved in the questions . . . leadership at FDA is very conscious now of the issues that have occurred in the past.”

While it waits for a panel meeting to be scheduled, Guided Therapeutics continues to make progress with its planned international launch and have orders in place with distributors for demonstration and clinical units for Europe and Asia, Faupel said.

“This is a product that we feel strongly will have a home not just in the U.S.,” Faupel told MDD. “It was designed to be low cost, easy to use, easy to train the user, [and] easy to interpret the results.”

Such features are what sets the technology apart from existing testing methods, he said.

“The current standard of care involves a lot of human interaction and data,” he said. He added that an initial PAP test, which requires a highly trained technician to interpret and that another test involving a magnified view of the cervix requires a well-trained physician to interpret and is subjective. “They all involve a lab delay to get a final answer, where as with our product you get a final answer at the point of care.”

The company was recently awarded $517,000 to fund the third year of a $2.5 million three-year grant from the National Cancer Institute (NCI). The grant provides additional resources to help commercialize and bring the LuViva to market. The company has been awarded more than $6 million in six consecutive grants from the NCI to develop the new test for detecting cervical disease since 2001 (MDD, Aug. 26, 2011).

In a multi-center clinical trial, with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports.

The company has also entered into a partnership with Konica Minolta Opto (Tokyo) to develop a non-invasive test for Barrett’s esophagus using the technology platform.

“This is a platform technology and we believe it can be utilized to detect nearly 90% of all cancers in the body,” Faupel said.

In fact, the company has already begun human testing of its light-based technology for Barrett’s Esophagus, a precursor for esophageal cancer. The feasibility study is designed to test the concept of using the platform for the detection of changes in esophageal tissue. The study also tests various hardware and procedural configurations and is designed to determine a way forward for product development and further clinical trials. The feasibility study is expected to enroll about 40 subjects and be completed before the end of the year. It is being conducted at two Atlanta-area clinics (MDD, Aug. 11, 2011).