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ADVANCE Discourse: Lab

Smart Contacts
July 24, 2014 5:04 PM by Michael Jones

We’ve discussed mobile medicine and hand-held technology before, but a recent partnership between drug manufacturer Novartis and internet juggernaut Google takes the theory to a whole new level. The two companies announced their collaboration to develop a smart contact lens to monitor blood sugar. Apart from the obvious implications of a “smart” piece of technology as small as a contact lens, the impact of results and information available “almost in real-time” could change the way diabetic patients monitor their blood sugar.

“It’s not going to happen overnight,” said Joe Jimenez, CEO at Novartis, in the New York Times article. “This will take a few years, as opposed to a few months.”

As a manufacturer, Novartis would understand the challenges of the development process better than most. The company had unsuccessfully attempted to produce glucose-monitoring contacts before. The new smart lens, based on Google’s prototype, utilizes “miniature sensors and a radio antenna thinner than a human hair to track glucose levels.” Additionally, Jimenez pointed out that the partnership with Google gave the project the technological step-ahead it needed in order to develop a more effective prototype.

“One of the biggest hurdles was miniaturization, and that’s one of the biggest benefits that Google X brings,” he continued. “This is a set of engineers that are really doing incredible things with technology.”

While the “smart” contact lenses remain in early stages of development, they represent a trend in healthcare towards personalized medicine and interactive testing. According to the NY Times story, as the general population continues to have a greater understand and, subsequently, take more control over their health, the healthcare and pharmaceutical industries are seeing an increased demand for improved medical technology. As of this year, both Apple and Samsung also offer individual health-monitoring technologies. 

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ACLA Comments to CMS
July 14, 2014 2:40 PM by Kerri Penno

In public comments presented to the CMS today, the American Clinical Laboratory Association (ACLA) provided input on various aspects of implementing relevant provisions of the Protecting Access to Medicare Act of 2014 ("PAMA"), which modifies the Medicare reimbursement rate methodology for lab services. 

"ACLA supports a measured and thoughtful analysis as well as robust stakeholder engagement in order to guarantee the new fee schedule continues to ensure adequate access to lab services for Medicare beneficiaries," said Alan Mertz, ACLA president.

ACLA's comments primarily focus on the need for CMS to develop or clarify definitions of several key terms, determine when private payor rates must be reported and for what timeframe, build a technology platform capable of accepting millions of discrete pieces of data, and establish coding processes for certain new tests.

A key definition identified by ACLA in its comments was "applicable laboratory" and ensuring that this encompasses the true private market. ACLA pointed out that the text of the statute, as well as Congress' intent, reflects that all major sectors of the laboratory market should be represented in reporting private payor rates, including independent laboratories and hospital outreach laboratories.

The way in which CMS defines the parameters, participants, methods, and timeframes for lab services payment rate and volume reporting, ACLA notes, will have a substantial impact on the rates that the Medicare program pays for clinical laboratory tests. It also has the potential to impact other payors' rates, as many private payors and state Medicaid programs base their reimbursement levels on Medicare rates. ACLA asserts that Medicare rates for lab services are best determined when payment and volume data reflect true market rates for clinical lab testing.

"Modifying the Medicare payment system for clinical laboratory services is a complex undertaking and ACLA is committed to ensuring the end result works for clinical labs, CMS, and Medicare beneficiaries," said Mertz. "Decisions made during this process will have a major impact on the clinical laboratory industry and the patients we serve, and it is important that those decisions work to promote ongoing diagnostic innovations and protect access to critical lab testing for Medicare beneficiaries."

To view ACLA's comments in their entirety, click here.

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A Pivotal First Step
July 10, 2014 3:01 PM by Michael Jones

Researchers from the Icahn School of Medicine at Mount Sinai and Harvard Medical School recently discovered a connection between a form of liver cancer and two mutations in the IDH gene. Intrahepatic cholangiocarinoma (iCCA) is the second most common form of liver cancer. Although there had previously been evidence of IDH mutations in patients with iCCA, this study marks the first time the exact genes, IDH1 and IDH2, have been targeted and identified specifically as a direct link. An story from Newswise detailed the study and subsequent findings.

“Our findings provide novel insights into the development of iCCA and offers a possible treatment option for patients suffering from this fatal disease,” said Josep Maria Llovet, MD, director of the liver cancer program at Mount Sinai’s Icahn School of Medicine, in the article.

The study demonstrated the effect of mutated IDH genes using mice, showing a decrease in the liver’s ability to health itself and an increase in “the number of cells to form a tumor. The gene mutations also resulted in a relationship with the KRAS gene, which is known to be linked to the development of cancer. The combination of these factors leads to formations of malignant legions in a liver with weakened defenses and, eventually, iCCA. According to the story, targeting IDH1 and IDH2 as pathways for iCCA has already resulted in new clinical trials to determine their impact on iCCA patients.

“iCCA is resistant to standard treatments like chemotherapy and radiation,” explained Llovet. “Understanding the molecular mechanism of the disease is the key to finding a treatment that works.”

Although the article pointed out, “there is no first-line, standard of care and no successful therapies” for patients with iCCA, the study has provided a necessary first step in the development of a treatment for the disease. The discovery has opened the door for further investigation into a relatively mysterious cancer and could potentially lead not only towards a broader understanding, but also a successful therapy. 

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Supercomputing and Big Data
June 18, 2014 11:30 AM by Michael Jones

The emergence of whole genome sequencing has certainly had an impact on both scientific research and clinical medicine, but there are still a few remaining hurdles preventing widespread use of the technology. While the ability to interpret the raw data provided by genetic testing relies on the computing power of laboratory instruments, few laboratories have the analytical equipment capable of that kind of speed. A recent news briefing from Dark Daily noted on recent study in which researchers at the University of Chicago, using software available to the public, successfully incorporated the “Beagle” Cray XE6 supercomputer in their genetic testing.

“Whole genome analysis requires the alignment and comparison of raw sequence data,” said Elizabeth McNally, MD, PHD, professor of medicine and human genetics and director of the cardiovascular genetics clinic at the University of Chicago’s School of Medicine, in the Dark Daily briefing. “[This] results in a computational bottleneck because of the limited ability to analyze multiple genomes simultaneously.”

According to the release, the research team was able to analyze 240 whole genomes simultaneously. Using the “Beagle,” for their study, titled “Supercomputing for the parallelization of whole genome analysis,” they looked at sequencing information from 61 patients -- which took less than 50 hours and only 25 percent of its total capacity. To put this into perspective, the Dark Daily briefing pointed out that, for a 2.1 GHz CPU, it would take “roughly 47 years to analyze the same data.” Because of this, most current laboratory practices simply analyze the human exome, which is comprised of only about 2 percent of the human genome responsible for protein coding. Although the briefing noted that this is considered to be the basis of 85 percent of “disease-causing mutations,” the ideal method for research would include the whole genome -- an approach that isn’t currently feasible for consistent use.

“By paying close attention to family members with genes that place then[m] at increased risk, but who do not yet show signs of disease, we can investigate early phases of the disorder,” continued McNally. “In this setting, each patient is a big-data problem.”

New screening technologies are continuing to improve the accuracy of testing technologies, but the laboratory’s ability to breakdown and investigate the results of those tests quickly and accurately is every bit as important. By successfully utilizing the “Beagle” supercomputer in the analysis of raw genetic data, the researchers at the University of Chicago have opened the door to improved options for understanding sequenced information. The potential of quicker interpretation capabilities in whole genome sequencing could lead to more standard genetic tests with faster turnaround times and, subsequently, a more cost-effective laboratory model. 

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"Neglected Variable"
June 11, 2014 10:47 AM by Michael Jones

A mouse is a mouse is a mouse is a mouse – or so the research community had thought. As it turns out, a major component has been missing from the majority of animal testing for clinical drug production: more female animals. In a recent article from the New York Times, experts in the field discussed the importance of incorporating more female subjects into clinical testing and the subsequent impacts of current, male-dominated models on women in terms of side-effects after production.

“One of the underlying assumptions has been that females are simply a variation on a theme, that it isn’t a fundamentally different mechanism, that if you’ve learned about the male you’ve learned enough to with both males and females,” said Jill Becker, PhD, a senior research scientist at the University of Michigan, in the article. “We’ve discovered that’s not always the case.”

The use of male animals as the primary subjects in clinical testing has resulted in some particularly harsh and often serious consequences for women once a drug has already been in production due to different physiological responses to a variety of treatments. An example of this is the FDA’s recent warning for women to cut Ambien pills in half because the female metabolic process in slower in processing the active ingredient. According to the NY Times Piece, the NIH has new policies regarding male and female testing scheduled to be introduced in October, with exceptions most likely to be made for gender-specific ailments like prostate and ovarian cancers.

“Every cell has a sex,” explained Janine A. Clayton, MD, director of the NIH office of research on women’s health, in the story. “Each cell is either male or female, and that genetic difference results in different biochemical processes within those cells.”

The article also predicted some resistance among scientists in the research community due to additional strains the new regulations might place on experiments as the inclusion of animals of both sexes could potentially double the number of subjects needed to deliver the necessary results. Additionally, the article noted scientists' concerns regarding the need for more extensive calculations made to factor in changes in hormones and the reproductive cycle. On the other hand, the long-term decrease in serious, potentially harmful side effects of drugs incorrectly calibrated for women stands to drastically improve the effectiveness of clinical medications.  

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The Genetic ABC’s
May 16, 2014 2:00 PM by Michael Jones

Imagine adding letters to the alphabet. Suddenly after centuries of working with 26 letters, there are just whole new possibilities for different words and phrases that had never been explored before. How would we use the new letters? As it turns out, research scientists at the Scripps Research institute in La Jolla, CA have been asking themselves the same question, but with a very different alphabet. According a recent article from NPR, Floyd Romesberg, PhD, along with the rest of the researchers in the department of chemistry, managed to introduce two new letters to the genetic alphabet.

“This is the first time that people have integrated a truly synthetic, manmade thing into the machinery -- in this case the most fundamental aspect of the machinery, the DNA -- and used it do something that system does, in this case store information,” said Romesberg in the NPR story. “And obviously we can now store more information than we could before

Romesberg and the research team created two synthetic letters in addition to A, C, T and G (adenine, cytosine, thymine, and guanine). Not only were the new codes successfully introduced into the DNA of a strain of E. coli, but they were duplicated as the cells multiplied, implying that the codes could be passed down. Of course, the findings remain in the preliminary stages of testing, but the prospect of new genetic combinations is especially exciting in terms of its impact down the road.

“Maybe you get three consonants and one vowel. Maybe there are some words you can write and you can string them together to make, sort of, primitive stories,” continued Romesberg. “But if you could have a couple extra letters, there’s more that you could write. Having the ability to store increased information would allow you to write more interesting words, bigger words, more complicated words, more nuanced words, better stories.”

While the team’s goal was simply to create fully integrated coding for the storage of genetic information, the new letters were intentionally left unreadable to the cells. According to the article, the next step for researchers will be to use the manmade letters to “use it to do something that a cell wouldn’t normally do -- like make a new kind of protein.” Along with the potential for a more advanced ability to engineer functions at the genetics level, the research could also provide additional insight on biology and even “how life got started in the first place.” 

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Crosstalk
May 2, 2014 1:13 PM by Michael Jones

It’s pretty widely agreed that stress can be unhealthy. Whether it comes down to high blood pressure, muscle tension or simply having trouble sleeping, the physical implications of stress can have physical implications on an otherwise healthy lifestyle. In a recent press release from Stem Cells Translational Magazine, researchers from both the UC-Davis Institute for Regenerative Cures and California State University examined the impact of stress in the healing process for chronic injuries and afflictions in a study led by Roslyn Isseroff, MD, and Mohan R. Dasu, PhD.

“The precise process that prevents their healing is unclear except for two constants: a prolonged inflammatory response and the bacterial colonization of the wound bed,” said Isseroff. “These two interrelated factors are thought to contribute to the wound’s chronic state.”

According to the release, the presence of a protein called epinephrine (adrenaline) functions to start the process of healing by increasing activity to TLR2. This allows inflation to occur and, as a result, promotes healing. The presence of bacteria, however, can cause “crosstalk,” disrupting the signals to epinephrine. In their study, the research team examined how increased epinephrine and TLR2 as a result of elevated stress levels could impact the stem cells and keratinocytes altered to help heal the wound, and found that the crosstalk produced by the increase led to the impaired healing of the injury.

“These findings have implications for understanding the mechanism controlling the differing susceptibility to infections and immune/inflammatory-related conditions in wounds,” commented Anthony Atala, MD, director of the Wake forest Institute for Regenerative Medicine and editor of Stem Cells Translational Medicine, in the release.

It’s important to remember to take a deep breath and relax sometimes, otherwise those annoying injuries that just won’t seem to go away might end up sticking around even longer. Not only is stress a mental strain, but the physiological impact can be detrimental to the healing process. The “crosstalk” seen in cell signals from increased stress can throw a wrench into the body’s natural ability to heal itself. 

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COLA Give Back Day
April 23, 2014 12:16 PM by Michael Jones

Not only does Medical Laboratory Professional’s Week (MLPW) celebrate the services provided by laboratorians throughout the year, but now it provides a platform from which to educate the public about the roles of these professionals and the potential for employment within the industry. Originally part of the “COLA Cares” initiative, “Give Back Days” began during MLPW 2011. In a recent interview with James Liggins, Chief Marketing Officer at COLA, he described the intended purpose of the “Give Back Days,” as well as the effect they have had on the industry overall.

“The reality is that, while job growth in this sector is faster than average, clinical laboratories across the nation have reported difficulties in recruiting new staff,” said Liggins. “This program is COLA’s way of helping to alleviate that worker shortage in the future.”

After the initial success of the MLPW 2011 Give Back Day in Baltimore, Md., COLA has continued the program annually, expanding to include local high schools, community colleges, universities and other venues. As the program has expanded, COLA staff members give presentations describing a day in the life of the typical medical laboratory professional, demonstrate simple laboratory tests and conduct fun experiments with participants.

“Our program now includes additional career presentations at schools, science expos and other venues; mentoring opportunities for interested students; and expanded scholarship support aid for students interested in medical laboratory careers,” explained Liggins. 

COLA’s Give Back Days feature a number of campaigns to increase awareness of the laboratory’s role in the healthcare industry and promote it as a viable career option. In addition to the outreach and continuing education programs offered during Give Back Day, COLA also offers scholarships to aspiring laboratorians and endowments to education programs catering towards future medical laboratory technologists.

 “We are also launching a course for allied health professionals, emphasizing the components of good clinical laboratory practices,” continued Liggins. “Designed for nurses and other healthcare personnel who work in hospitals, clinics and physician’s offices, the course will provide non-laboratorians with a basic knowledge of quality laboratory testing procedures in healthcare settings.”

The course, “Fundamentals of Clinical Laboratory Testing,” will be offered through Howard Community College’s continuing education program.  COLA hopes to expand the program elsewhere throughout the U.S. in the future.

MLPW is a time to celebrate the work of laboratories across the country, but why not use the spotlight to promote the profession among the rest of the industry and potential co-workers? In addition to their Give Back Days, COLA is also in the process of implementing “COLA Giving Back 365 Days a Year,” which will expand on areas already covered and include a new disaster relief program. AS Part of MLPW, COLA encourages laboratories everywhere to take part in COLA’s Give Back program with a free kit offered on their website (www.colacares.com/resources).

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"Missing Link"
April 7, 2014 1:36 PM by Michael Jones

Type 2 diabetes has been a growing concern in the United States for several years. While the established research has pointed to two specific hormones, glucagon and insulin, as the primary factors leading to the development of the disorder in patients, researchers have discovered a third key player in a recent news release from Johns Hopkins. The Johns Hopkins scientists discovered that Kisspeptin 1 (K1), a hormone typically associated with puberty and fertility, directly influences and interferes with the production of insulin in the pancreas.

“Glucagon and insulin alone never really made complete sense,” said Mehboob Hussain, MD, lead investigator, endocrinologist and metabolism expert at the Johns Hopkins Children’s Center. “There was always something missing and, we feel, kisspeptin 1 is a very good candidate to be that missing part. All of our findings point in this direction.”

According to the release, the general opinion prior to the discovered impact of K1 was that the slow build-up of blood sugar due to elevated levels of glucagon eventually tired out the pancreatic beta cells responsible for insulin secretion. Instead, it seems that, rather than the cells slowly wearing out, high glucagon triggers the production of K1, which targets the cells and suppresses the secretion of insulin, leading to the high blood sugar and low insulin levels associated with the disorder. In experiments with human blood and liver cells and eventually mice, once the Johns Hopkins researchers rendered their livers incapable of producing K1, the levels of insulin and blood sugar returned to normal.

“Our findings suggest that glucagon issues the command, but K1 carries out the orders,” explained Hussain. “And, in [doing so,] it appears to be the very cause of the declining insulin secretion seen in type 2 diabetes.

Additionally, Hussain and his colleagues speculated that the evolution of K1 arose from the need to prevent dramatic decreases in blood sugar during fight-or-flight situations. This research, while still in its preliminary stages, has offered a third key component in the assessment of type 2 diabetes and the possibility of a new method of treatment for the disorder. Rather than treating as needed with the injection of insulin, the disorder could potentially be cured by limiting and even eliminating the production of K1. 

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Stem Cells and Nerve Damage
March 25, 2014 4:27 PM by Michael Jones

Regenerative medicine is a field that seems like something right out of the pages of science fiction. In a recent study from the University of Pittsburgh Medical Center (UPMC), researchers studied the effect -- and subsequent success -- of stem cells derived from human muscle tissue in repairing nerve damage in mice. A UPMC press release detailed the study and speculated on the potential impacts to the healthcare industry given the results of the experiment.

“This study indicates that placing adult, human muscle-derived stem cells at the site of peripheral nerve injury can help heal the lesion,” said Johnny Huard, PHD, senior author and professor of orthopedic surgery, UPMC School of Medicine. “The stem cells were able to make non-neuronal support cells to promote regeneration of damaged nerve fiber.”

According to the release, the study involved creating a quarter-inch defect in the sciatic nerve of test mice and then treating with “cultured human muscle-derived stem/progenitor cells” injected into the damaged nerve. It noted that treatments for peripheral nerve damage have had limited success so far, so the introduction of a successful treatment utilizing regenerative medicine techniques is a promising start -- even if it was only in the preliminary stages of testing. Not only did the treated mice experience full regeneration in the nerve, but the study also found that the mice eventually experienced a restored gait.

“Even 12 weeks after the injury, the regenerated sciatic nerve looked and behaved like a normal nerve,” commented Mitra Lavasani, PHD, assistant professor of orthopedic surgery at the UPMC School of Medicine and author of the study. “This approach has great potential for not only acute nerve injury, but also conditions of chronic damage, such as diabetic neuropathy and multiple sclerosis.”

The ability to heal living organisms simply by using their own biological materials puts modern science in view of fictional pipedreams. The early success of tests incorporating regenerative medicine could potentially make room for uses in healthcare for humans. The press release specified injury repair and the developments of “delivery systems, such as gels,” and a prospective next step in healing larger areas. 

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Advances in Organ Transportation
February 19, 2014 10:18 AM by Michael Jones

For as developed and state-of-the-art as modern medicine has become, the standard practice for organ transportation has a lot of catching up to do. Typically moved from facility to facility in an ice-filled cooler via helicopter or some other form of emergency vehicle, the tissues in organs start to breakdown and the organ becomes unusable after a certain period of time. A recent article from NPR covered a potential breakthrough for the storage and transportation of lung (and possibly heart) transplants. 

“For the first time, the donor lungs can be maintained in a breathing, warm, nourished state during transport,” said Abbass Ardehali,MD , transplant surgeon at the UCLA School of Medicine in the NPR story.

According to the story, the “lung in a box” or Organ Care System “circulates blood through the lungs and pumps oxygen through the lobes.” Essentially, this allows the lungs to continue to function for an extended period of time before being utilized for a transplant.  The company behind the “lung in a box,” TransMedics, is also working on similar technology to keep hearts beating outside the body -- the NPR story even noted that it “keeps a heart warm, pumps blood through it and feeds it nutrients.”  Additionally, the portable nature of the machine allows it to be transported with the organ to ensure better preservation during longer journeys.

“On an annual basis, more than 30 or 40 hearts in Hawaii go unused,” continued Ardehali in the NPR piece. “Because of the distance, these hearts cannot be transported to the mainland.”

Although the technology for the “lung in a box” has not yet been approved by the FDA, the NPR story mentioned trials and studies either underway or in preparation to test the equipment’s effectiveness. Ardehali commented on Hawaii, noting the sometimes extended amounts of time it takes to transport vital donor organs – especially from more extreme distances. Due to these concerns, the benefits of the technology behind the Organ Care System could be substantial for those waiting on transplant lists across the country.  

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Crowdsourcing: Funding Vs. Information
February 13, 2014 2:22 PM by Michael Jones

In a recent post, I covered some unique opportunities presented by crowdfunding for technological advances in areas like molecular diagnostics. While the crowdsourcing mentality can work well in gathering funds for equipment producers, crowdsourcing medical information through sites like Wikipedia can carry more limitations and even dangers. A recent article from NPR opened up discussion on the subject.

“I think that’s the double-edged sword of Wikipedia,” said Amin Azzam, MD, MA, professor of psychiatry at the University of California, in the NPR piece. “Because anyone can edit, we don’t necessarily know the expertise of the people doing the editing. [On] the other hand, the reason it’s so popular is because everyone can contribute.”

The story noted that, according to a January IMS Health Institute study, Wikipedia is “the ‘single leading source’ of healthcare information for both patient and healthcare professionals.” Due to the website being open to the open to public editing, this is not always a benefit and can lead to the circulation of incorrect medical information. According to the article, Azzam teaches a course in which he works with fourth-year medical student to clean up the material available on Wikipedia, editing pages and improving the quality of information.

“It’s not just adding references and not just improving the gaps,” continued Azzam in the NPR piece, “but thinking about how to make it more readable and more digestible for the people that are reading Wikipedia.”

An intriguing side effect of having student edit the pages, as noted both by Azzam, is that they were forced to present the information in a way readers could comprehend. One commenter on the NPR page even took it a step further and wrote, “Med School students editing Wikipedia articles does something else which no one here has commented upon--it just might help the future doctors learn to talk to Patients in a way that the patients can understand,” suggesting that the practice could also potentially improve patient communication.

 

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Crowdfunding MDx
February 5, 2014 4:38 PM by Michael Jones

We’re all familiar with the popularity of crowdfunding websites like Kickstarter for both the largely successful and also the somewhat misguided attempts to gather funding for movies and music videos, but lately a much more serious group has turned to crowdfunding: clinical researchers. In an effort to gain additional funding for its handheld POC DNA test for malaria and drug resistance, tentatively called “Q-POC,” a biotech company based in Newcastle, UK, QuantuMDx Group, decided to turn to internet-based public funding on Indiegogo as of February 12, 2014. A recent video explains the technology as well as the concept of the project.

“Our Crowdfunding campaign is unique,” explained Elaine Warburton, OBE, CEO of QuantuMDx, in a press release. “Not only are we looking for contributors to support this phenomenally worthy cause to help save many hundreds if not thousands of children’s lives, but we’re also offering everyone the chance to leave a lasting legacy in the fight against malaria by contributing their winning ideas to the look and feel of our device and to take part in re-naming it from the current research name of Q-POC.”

According to the press release, the world loses one child per minute due to malaria. The impact of a handheld DNA testing assay without the need for clean water or a stable electricity source could make all the difference in developing nations and countries in need. The funds rasied via Indiegogo will go towards further development and the effort to expand clinical trials for the new technology.

“We have spent years developing our tech and we now have a prototype device that has completed a sample-to-result malaria DNA test in under 15 minutes,” said Jonathan O’Holleran, CSO of QuantuMDx and inventor of their signature handheld assay, in the press release. “Contributions will help take our life-saving device from the lab to the field and directly save lives. We have health workers around the world crying out for our technology and are now receiving the support of major MGOs, we just need help to finalize our development and drive the technology through clinical trials.”

I’ve discussed handheld options and extreme POCT before. In a domestic capacity, similar handheld devices to the “Q-POC,” could potentially change how we care for home-bound patients, while the foreign applications are virtually limitless -- especially in regards to developing nations. For modern clinical laboratories, the addition of a fully mobile, handheld molecular testing device could change the concept of laboratories and expand the reach of modern medicine.

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Sunshine Act on Cloudy Finances
January 29, 2014 3:37 PM by Michael Jones

The implementation of the Affordable Care Act, or ObamaCare, has already seen several new laws and regulatory measures introduced since its implementation, with many more soon to be on the horizon. One of these is the Sunshine Act, a law requiring public disclosure of any financial agreements between healthcare vendors and providers. Recent articles from both the New England Journal of Medicine (NEJM) and Dark Daily discussed the specifics of the new law and the potential impact to those affected in the healthcare industry.

In terms of the specifics, the Sunshine Act became effective on August 21, 2013 and the NEJM story identified all drug or device manufacturers in the US, as well as doctors of medicine, osteopathy, dentistry, podiatry, optometry, chiropractic medicine, physicians and teaching hospitals. In order for an amount to require disclosure, it must be a transaction of at least $10 or more than $100 annually. The law also requires that certain items also be reported, including “cash or a cash equivalent, in-kind items or services, stock, consulting fees, compensation for services other than consulting, honoraria, gifts, entertainment, food, travel (including the destination), education, research, charitable contributions, royalties or licenses, current or perspective ownership or investment interest, speaker compensation for CME events and grants.”

Additionally, the Dark Daily piece discussed some concerns about the financial disclosure, specifically regarding the strain placed on the relationship between patients and providers. While the impact of financial records being made available online could be substantial for “computer-savvy patients,” there is also concern that availability of this information could jeopardize the trust between patients and physicians, leading patient to ultimately question a doctor’s decisions. The information is set to be published as of September 2014.

“Whether transparency will lead to fewer relationships is really the million dollar question,” commented Daniel Carla, MD, director of the Pew Charitable Trusts Prescription Project, in the Dark Daily piece. “The kinds of relationships that may drop off may well be the most inappropriate relationships.”

The story went on to note that Carla also mentioned the possibly of pharmaceutical companies or medical equipment manufacturers finding new ways to maintain relationships with physicians and clinicians. The NEJM article, on the other hand, examined the purpose of the program: “to provide objective information on the type of financial relationships that exist between manufacturers or GPOs and physicians or hospitals.” Regardless of the predicted changes, the Sunshine Acts stands leave its mark across the healthcare industry.

Apart from its impact on industry vendors, providers and patients, the Dark Daily briefing also noted another area that stands to be affected: the laboratory. According to the Dark Daily article, the impact could be seen by pathologists and laboratory professionals, especially in the case of in vitro diagnostics, manufacturers of which fall under the vendor category of the new law. In the coming future, new policies -- not only federal, but within the companies themselves -- should be taken into account for laboratory professionals. 

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Geisinger Partners with Regeneron Pharmaceuticals
January 21, 2014 11:49 AM by Michael Jones

The influence of genetic sequencing has left its mark across the healthcare industry. In a recent partnership with Pennsylvania’s Geisinger Health System, Regeneron Pharmiceuticals, who recently came out with Eylea for age-related macular degeneration, is looking to take some of the the first substantial steps in making that vision a reality. A recent story from the New York Times detailed the extent of the project.

According to the article, the price of whole genome sequencing has already dropped significantly since it was first announced and continues to do so as more and more advancements are made in the field, it hasn’t quite reached the “$1000 genome” mark yet. As such, the collaboration between Regeneron Pharmiceuticals and Geisinger Health will mainly be focused on patient exomes rather than the entire genome at first. The study, which reflects smaller projects across the country and around the world, will be mutually beneficial to both parties.

 “Scientifically and medically, it’s pretty exciting,” said Leslie G. Biesecker, MD, chief of the genetic disease research branch at the National Human Genome Research Institute, in the New York Times piece. “As far as I’m aware, it’s the largest clinical sequencing undertaking in this country so far by a long shot.”

All patient information used by Regeneron will remain confidential and used for research, while Geisinger will be able to keep the patient data for their own records. The New York Times article continued, noting similar public studies in Britain, Saudi Arabia, and varying health systems across the United States. Additionally, the department of veterans affairs is also planning a large-scale DNA collection as the price of sequencing continues to drop.

Since it was announced over a decade ago, the industry has been expecting a surge of new drugs targeting our genome. The potential Impact of prescriptions that function and work directly with a patient’s DNA stands as a landmark in treatments. As genetic medicine is a field that has been poised to expand rapidly for years, the industry can finally expect to see more genetic-based treatments and medications along with increased testing for patients with the shrinking cost of sequencing options. 

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