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TABLE OF CONTENTS             January 10, 2017      
Red arrow QIAGEN submits QuantiFERON - TB Gold Plus for U.S. regulatory approval

Red arrow Evaluation of SpeeDx’s CE-marked ResistancePlus MG test for
M. genitalium published

Red arrow Submissions for MLO’s “Lab of the Year” due January 20

Red arrow Purdue researchers uncover new Zika structure

Red arrow Maximum shelf life of red blood cells should be reduced

Red arrow Egalet painkiller wins FDA approval but label disappoints

Red arrow HOT CLIPS:  Women's Health – Top Picks
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QIAGEN submits QuantiFERON - TB Gold Plus for U.S.
regulatory approval

QIAGEN announced the submission of QuantiFERON-TB Gold Plus (QFT-Plus), the fourth generation of the modern blood test for detecting tuberculosis (TB) infection, for pre-market approval (PMA) by the U.S. Food and Drug Administration (FDA).

The U.S. submission follows the launch during 2016 and positive uptake of QuantiFERON-TB Gold Plus in more than 60 countries across Europe, the Middle East, Africa, Asia and Latin America, where more than 600,000 of the new tests have already been used.

QFT-Plus builds on the foundation of QuantiFERON-TB Gold (QFT), the third-generation version of the world’s leading interferon gamma release assay (IGRA), which has been established as a cost-effective and efficient tool for TB infection testing with more than 30 million tests conducted worldwide since its initial launch. The fourth-generation QFT-Plus test adds proprietary CD8 antigens and workflow improvements that allow for even more efficient implementation, especially in large-scale TB screening programs. These include a single-tube blood collection option, as well as the current use of the unique "assay in collection tube" design that allows for immediate stimulation of the blood sample.

Six independent peer-reviewed publications to date have supported the performance of QFT-Plus, and additional studies are currently underway in 22 countries involving more than 30,000 patients. The first studies include comparisons on sensitivity in active TB and close contacts, as well as on laboratory precision and correlation to flow cytometry.

The transition to the fourth generation of the QuantiFERON TB test comes amid a series of new recommendations that will broaden the use of IGRAs in the United States.

Both the USPSTF and new ATS/CDC recommendations referred to QuantiFERON-TB Gold as one of two FDA-approved IGRAs, preferable in certain patient groups to the century-old tuberculin skin test (TST). The ATS/CDC recommendations also highlighted the expert committee’s rationale for expanded IGRA use based on the accuracy of IGRAs to minimize the risk of unnecessary TB treatment and related drug toxicity issues.

Tuberculosis is a contagious bacterial infection spread primarily by coughing of patients with the active pulmonary form of the disease. In 2015, WHO estimates, there were 10.4 million new cases of active TB worldwide and 1.8 million deaths from TB.

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Evaluation of SpeeDx’s CE-marked ResistancePlus MG test for
M. genitalium published

SpeeDx Pty. Ltd. announced that the study, Evaluation of a commercial multiplex PCR assay for simultaneous detection of Mycoplasma genitalium and macrolide resistance-associated mutations in clinical specimens, by Chloe´ Le Roy, Nadège He´nin, Ce´cile Be´bear and Sabine Pereyre has been accepted for publication by the Journal of Clinical Microbiology.

The authors concluded: “the ResistancePlus MG kit is a rapid and reliable method to simultaneously detect M. genitalium and determine macrolide resistance in clinical specimens.”

Macrolide antibiotics are the first-line treatment for the rapidly growing problem of M. genitalium STIs, but resistance to these antibiotics has increased up to 40 percent in several countries. Because of this growing antibiotic resistance problem, in 2016 the European guideline on M. genitalium infections recommended complementing the molecular detection of M. genitalium with an assay capable of detecting macrolide resistance-associated mutations.

Currently, there isn’t a Food & Drug Administration (FDA) cleared molecular diagnostic test for M. genitalium in the U.S. The SpeeDx assay provides valuable information to clinicians in a rapid timeframe allowing for better treatment of patients infected with M. genitalium. Timely detection of potential antibiotic resistance will enable the development of better algorithms for the treatment of M. genitalium infection and promote responsible stewardship of antibiotics.

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Submissions for MLO’s “Lab of the Year” due January 20

Medical Laboratory Observer (MLO) is gearing up to honor three outstanding clinical laboratories. A first-prize winner and two runners-up will be selected and saluted in the April 2017 issue.

Online nominations are being accepted through January 20. Clinical labs of any size and location are eligible for consideration.

Any nomination must be original and exclusive to MLO and not have been submitted, either original or edited, to any other publication or online media outlet currently or within the previous year.

The goal is to demonstrate your lab’s contributions to quality patient care and to consider the categories under which you are asked to describe your lab: Customer Service, Productivity, Teamwork, Education and Training, Strategic Outlook and Lab Inspections.

The MLO team looks forward to reading about some exemplary and inspiring labs—and celebrating in print how three of them are having a positive impact on the profession and on patient care in their communities.

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Purdue researchers uncover new Zika structure

A new discovery from Purdue University researchers on the structure of the Zika virus could help determine how the virus infects cells and spreads. The research team — which included two professors who led a team last spring that determined the structure of Zika — recently identified the near-atomic resolution structure of Zika before it matures.

Zika belongs to a family of viruses called flaviviruses, which also includes West Nile, yellow fever and dengue. While only mature forms of flaviviruses are considered infectious, the virus population secreted from host cells is a mixture of mature, partially mature and immature virus particles, according to a Purdue news release.

That means it's probable the immature form of Zika plays a role in virus infection and spread, said Michael Rossmann, biological sciences professor.

"I think these findings open the door to begin to explore the assembly process of the virus," said Richard Kuhn, director of the Purdue Institute for Inflammation, Immunology and Infectious Diseases, in the release. "We see clear differences between the structure of the immature virus and the mature virus. Not only are there differences in the outer structure, but the inner core must also undergo some significant changes during maturation. We need to study what these changes are and why they occur."

In their spring discovery, Rossmann and Kuhn's team also identified regions within the Zika virus structure where it differs from other flaviviruses. Any unique regions within the virus' structure have the potential to explain differences in how it's transmitted and how it manifests as a disease. Ultimately, understanding the structure of a virus is vital to the development of antiviral treatments and vaccines.

Rossmann said their next goal is to study different ways in which the virus can be kept under control. He said they recently submitted a joint application to receive an NIH grant for the research.

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Maximum shelf life of red blood cells should be reduced

The oldest blood available for transfusions releases large and potentially harmful amounts of iron into patients' bloodstreams, a new study by researchers at Columbia University Medical Center (CUMC) has found.

Based on the new findings, the researchers recommend that the FDA reduce the maximum storage limit of red blood cells from 6 weeks to 5 weeks, as long as there are sufficient blood supplies available.

"Our recommendation will be controversial, but we think we have real data to support it," said the study's co-leader Steven Spitalnik, MD, professor of pathology & cell biology at CUMC and medical director of the clinical laboratories at NewYork-Presbyterian/Columbia. "Recent studies have concluded that transfusing old blood has no impact on patient outcomes, but those studies didn't exclusively examine the oldest blood available for transfusions. Our new study found a real problem when transfusing blood that's older than 5 weeks."

Transfusion of red blood cells is the most common procedure performed in hospitalized patients, with approximately 5 million patients receiving red blood cell transfusions annually in the United States. "But the longer you store blood, the more the cells become damaged," said the study's co-leader Eldad Hod, MD, associate professor of pathology & cell biology at CUMC and clinical pathologist at NewYork-Presbyterian/Columbia. Currently, the U.S. FDA allows units of red blood cells to be stored for up to 6 weeks before they must be discarded.

In the study, the researchers randomly assigned a group of 60 healthy volunteers to receive a unit of red blood cells that had been stored for 1, 2, 3, 4, 5, or 6 weeks. The volunteers were then monitored for 20 hours after transfusion.

Within hours after transfusion, 7 of the 9 volunteers who received the 6-week-old blood could not appropriately metabolize the damaged cells, thereby releasing large amounts of iron into their bloodstream. Only one volunteer who received younger blood had a similar response, with blood had been stored for five weeks.

None of the volunteers were harmed by the transfusion, but previous studies have shown that excess iron can enhance blood clots and promote infections. "Based on the amount of iron circulating in the blood of the volunteers who received 6-week-old blood, we'd predict that certain existing infections could be exacerbated," said Dr. Hod.

The true impact of 6-week-old blood on the rate of complications in patients is likely to be small, the researchers say, but since millions of Americans receive transfusions each year, even a 1 percent difference in complications could affect a large number of patients.

"It's estimated that up to 10 to 20 percent of blood units used for transfusions have been stored for more than 5 weeks, so the number of patients who are likely to receive a unit of very old blood is substantial," Dr. Hod added.

"Based on our findings of potential harm, we think the prudent thing to do at this time is for the FDA to reduce the maximum storage period," said Dr. Spitalnik. "The U.K., Ireland, the Netherlands, and the National Institutes of Health have limited storage to 35 days, and we think that can be achieved throughout the U.S. without seriously affecting the blood supply."

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Egalet painkiller wins FDA approval but label disappoints

The U.S. Food and Drug Administration (FDA) approved Egalet Corp's long-acting opioid painkiller, Arymo ER, and will allow the company to claim it deters abuse by those seeking to dissolve and inject it.

However, investors had hoped the company would also be allowed to claim the drug deters abuse by those seeking to snort or chew it. That did not happen, and the company's shares fell 5 percent to $8.00 after the market closed.

Details about the label were revealed only after the announcement of the approval, which initially sent the shares up 27 percent.

The FDA's decision ran counter to a recommendation by its advisory panel, which in August voted 18-1 in favor of approval. The panel recommended the drug be labeled as an abuse-deterrent product via all three routes: oral, nasal and intravenous.

The FDA typically follows the advice of its advisory panels but is not obliged to do so.

Arymo ER is a long-acting variation of morphine that is intended to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment.

The FDA said in a statement that an extended-release morphine product made by Daiichi Sankyo, MorphaBond, has market exclusivity on the ability to claim it deters snorting. The company is exclusively allowed to make that claim until Oct. 2, 2018.

The FDA did not say whether it will allow Egalet to make the snorting-deterrence claim when Daiichi's exclusivity runs out, but it will be able to do so if it wishes.

The FDA did not approve a claim that the drug deters abuse via the oral route.

The abuse of opioids, a class of drugs that includes heroin and prescription pain-killers, has reached epidemic proportions in the United States. The Centers for Disease Control and Prevention estimates that 78 Americans die every day from an opioid overdose.

Egalet plans to launch Arymo ER, approved in three dosage strengths: 15 mg, 30 mg and 60 mg, in the United States in the first quarter of 2017.

The same advisory panel that recommended Egalet's drug also recommended the FDA approve a long-acting opioid made by Teva Pharmaceutical Industries Ltd, Vantrela ER.

It also recommended approval of a long-acting, abuse-deterrent opioid made by Pfizer Inc, Troxyca ER, although it had reservations about the drug's ability to curb all forms of abuse.

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HOT CLIPS: Women's Health - Top Picks

Click on the highlighted links below to discover the top MLO archival properties concerning Women's Health, a topic that is now at the forefront of healthcare discussions.

Unmet clinical needs in cervical cancer screening

Novel HER2 dual in situ hybridization (DISH): technique and implementation in routine laboratory testing

Companion diagnostics: the key to personalized treatment of breast and ovarian cancer

Anti-Müllerian hormone (AMH) and its significance in women’s fertility

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