FDA grants clearance to Hologics assay for detection of common sexually transmitted

first_imgReviewed by Kate Anderton, B.Sc. (Editor)Jan 23 2019Hologic, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted clearance for its Aptima® Mycoplasma genitalium assay, the first and only FDA-cleared test to detect this under-recognized but increasingly common sexually transmitted infection (STI). This newest Aptima assay joins a growing suite of market-leading tests offered by Hologic to help combat the rise of STIs in the U.S.Hologic’s first-in-category assay, cleared through the FDA’s De Novo request process, provides laboratories with a highly sensitive and specific molecular diagnostic method to identify infections and enable effective treatment.First discovered in the early 1980s, Mycoplasma genitalium (M. genitalium) was listed as an emerging public health threat by the U.S. Centers for Disease Control and Prevention (CDC) in 2015. Current estimates indicate that M. genitalium may affect more than 15 percent of men and women in certain high-risk populations, and its prevalence is growing.3 Because of the lack of an FDA-cleared test until now, M. genitalium has often been misdiagnosed as other STIs and, in some cases, treated with the wrong antibiotics. This often leaves the underlying infection untreated, which can lead to increased transmission and recurrent infections.”Although Mycoplasma genitalium is typically more common than gonorrhea, there is very little public awareness of this rising sexually transmitted infection, which can cause serious and potentially devastating health problems,” said Damon Getman, Ph.D., senior principal research scientist and director of research at Hologic. “The introduction of the Aptima Mycoplasma genitalium assay gives healthcare professionals the opportunity to provide optimal care for their patients and reflects Hologic’s commitment to developing innovative solutions that address emerging public health threats.”In men, M. genitalium symptoms may include urethritis, the swelling and inflammation of the urethra. In women, M. genitalium has been linked to cervicitis, the swelling and inflammation of the cervix. If left untreated, infections can lead to infertility in women and increased risk of HIV acquisition and transmission. Patients infected with M. genitalium may be asymptomatic or experience symptoms similar to those associated with a chlamydial infection, so accurate diagnostic tests are critical to help healthcare professionals and their laboratory partners identify these bacterial infections and treat them appropriately. Research has shown as many as 50 percent of women and 42 percent of men with M. genitalium may have an antibiotic-resistant strain, further emphasizing the importance of early detection and regular screening.Related StoriesChronic inflammation removes motivation by reducing dopamine in the brainPipettes of the Future: Automation for AccelerationBioTek introduces new Scratch Assay Starter Kit”We are tremendously proud of the team of scientists and engineers who developed this assay,” said Tom West, Hologic’s division president, Diagnostic Solutions. “They exemplify Hologic’s dedication to help arm laboratories and healthcare professionals with superior diagnostic tools to identify harmful infections, and this FDA clearance represents another milestone in furthering that mission.”In published research, Hologic’s ribosomal RNA-based M. genitalium assay displayed greater sensitivity than lab-developed or CE-marked DNA-based tests . Hologic introduced the first FDA-cleared diagnostic test kit for STIs in the 1990s using its innovative RNA-based technology. Since then, Hologic has expanded its Aptima STI portfolio to include assays for chlamydia, gonorrhea, human papillomavirus (HPV), herpes simplex viruses (HSV 1&2), trichomonas, and Zika virus. The Aptima virology portfolio also includes quantitative assays for the human immunodeficiency virus (HIV) and hepatitis B and C (HBV and HCV). All are available on Hologic’s fully-automated Panther® system. In 2017, the Aptima assays helped an estimated 40 million patients obtain fast, high-quality test results.Including the first IVD for the detection of Mycoplasma genitalium, Hologic’s Panther and Panther Fusion® system now offers 14 FDA-cleared or approved assays that detect more than 20 pathogens, making it the only high-throughput molecular diagnostic platform in the United States to combine comprehensive sexual health, cervical health, viral load, respiratory testing and open channel10 functionality on a fully automated system.Source: https://www.hologic.com/last_img read more

Documents show Facebook used user data as competitive weapon Update

first_imgIn this April 10, 2018, file photo Facebook CEO Mark Zuckerberg pauses while testifying before a joint hearing of the Commerce and Judiciary Committees on Capitol Hill in Washington about the use of Facebook data to target American voters in the 2016 election. The British Parliament has released some 250 pages worth of documents that show Facebook considered charging developers for data access. The documents show internal discussions about linking data to revenue. (AP Photo/Andrew Harnik, File) This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only. The cache includes emails from Zuckerberg and other key members of his staff. The emails show Zuckerberg and other executives scheming to leverage user data to favor companies not considered to be threats and to identify potential acquisitions.Collins said the emails raise important issues, particularly around the use of the data of Facebook users. “The idea of linking access to friends’ data to the financial value of the developers’ relationship with Facebook is a recurring feature of the documents,” Collins said.The committee’s summary said the company used surveys of what mobile app customers were using to decide which companies to acquire. It also said Facebook knew that an update to its Android mobile app phone system—which enabled the Facebook app to collect user call logs—would be controversial.”To mitigate any bad PR, Facebook planned to make it as hard as possible for users to know that this was one of the underlying features of the upgrade of their app,” the summary said.Facebook executives clearly understand the material is valuable. An unsigned memo setting policy for a system upgrade known as “Platform 3.0” rejected anyone who could be construed as a competitor. This March 28, 2018, file photo shows the Facebook logo at the company’s headquarters in Menlo Park, Calif. The British Parliament has released some 250 pages worth of documents that show Facebook considered charging developers for data access. (AP Photo/Marcio Jose Sanchez, File) In a Facebook post , Facebook CEO Mark Zuckerberg sought to put the documents in context. “Of course, we don’t let everyone develop on our platform,” he wrote. “We blocked a lot of sketchy apps. We also didn’t allow developers to use our platform to replicate our functionality or grow their services virally in a way that creates little value for people on Facebook.”The U.K. committee seized the documents from app developer Six4Three, maker of a now-defunct bikini-picture search app. Six4Three acquired the files as part of a U.S. lawsuit that accuses Facebook of deceptive, anti-competitive business practices. The documents remain under court seal in the U.S.In a summary of key issues pertaining to the documents, the committee said Facebook “whitelisted,” or made exceptions for, companies such as Airbnb and Netflix, giving them continued access to users’ “friends” even after the tech giant announced changes in 2015 to end the practice.”Facebook have clearly entered into whitelisting agreements with certain companies, which meant that after the platform changes in 2014/15 they maintained full access to friends data,” the committee said in a statement. “It is not clear that there was any user consent for this, nor how Facebook decided which companies should be whitelisted or not.” Facebook mulled charging for access to user data The parliament’s media committee accused Facebook on Wednesday of cutting special deals with some app developers to give them more access to data, while icing out others that it viewed as potential rivals. In other documents, company executives discussed ways to obfuscate how the company was collecting and exploiting user data.The committee released more than 200 pages of documents on the tech giant’s internal discussions about the value of users’ personal information. While they mostly cover the period between 2012 and 2015 —the first three years after Facebook went public—they offer a rare glimpse into the company’s inner workings and the extent to which it used people’s data to make money while publicly vowing to protect their privacy.Facebook said the documents are misleading and that the information they contain is “only part of the story.””Like any business, we had many internal conversations about the various ways we could build a sustainable business model for our platform,” the company said in a statement. “But the facts are clear: We’ve never sold people’s data.” Citation: Documents show Facebook used user data as competitive weapon (Update) (2018, December 5) retrieved 17 July 2019 from https://phys.org/news/2018-12-uk-parliament-internal-facebook-documents.html In this file photo dated March 29, 2018, the logo for social media giant Facebook, appears on screens at the Nasdaq MarketSite, in New York’s Times Square. The British Parliament’s media committee seized confidential Facebook documents from a developer and on Wednesday Dec. 5, 2018, has released a cache of documents that show Facebook considered charging developers for data access. (AP Photo/Richard Drew, FILE) In this May 1, 2018, file photo, Facebook CEO Mark Zuckerberg makes the keynote speech at F8, Facebook’s developer conference in San Jose, Calif. The British Parliament has released some 250 pages worth of documents that show Facebook considered charging developers for data access. The documents show internal discussions about linking data to revenue. “There’s a big question on where we get the revenue from,” Zuckerberg said in one email. “Do we make it easy for devs to use our payments/ad network but not require them? Do we require them? Do we just charge a rev share directly and let devs who use them get a credit against what they owe us? It’s not at all clear to me here that we have a model that will actually make us the revenue we want at scale.” (AP Photo/Marcio Jose Sanchez, File) “There are a small number of developers whom no amount of sharing to FB or monetary value can justify giving them access to Platform,” the memo said. “These developers do not want to participate in the ecosystem we have created, but rather build their own ecosystem at the expense of our users, other developers and, of course, us. That is something that we will not allow.”The documents also suggest Facebook would jealously safeguard its interests. In a January 2013 email exchange, Zuckerberg signed off on cutting access to Twitter’s Vine video-producing app, which had allowed users to find friends via Facebook.”Unless anyone raises objections,” Facebook Vice President Justin Osofsky wrote, the company would cut Vine’s access to users’ friend networks. “We’re prepared reactive PR.””Yup, go for it,” Zuckerberg replied.The documents also suggest robust internal discussions about linking data to revenue.”There’s a big question on where we get the revenue from,” Zuckerberg said in one email. “Do we make it easy for (developers) to use our payments/ad network but not require them? Do we require them? Do we just charge a (revenue) share directly and let (developers) who use them get a credit against what they owe us? It’s not at all clear to me here that we have a model that will actually make us the revenue we want at scale.” The documents “raise important questions about how Facebook treats users’ data, their policies for working with app developers, and how they exercise their dominant position in the social media market,” said committee chair Damian Collins. “We don’t feel we have had straight answers from Facebook on these important issues, which is why we are releasing the documents.” Internal Facebook documents released by a U.K. parliamentary committee offer the clearest evidence yet that the social network has used its enormous trove of user data as a competitive weapon, often in ways designed to keep its users in the dark. Explore further © 2018 The Associated Press. All rights reserved.last_img read more

Flights scrapped as Berlin airports brace for Monday strike

first_img © 2019 AFP Citation: Flights scrapped as Berlin airports brace for Monday strike (2019, January 6) retrieved 17 July 2019 from https://phys.org/news/2019-01-flights-scrapped-berlin-airports-brace.html The action, called by the powerful Verdi union at the German capital’s Tegel and Schoenefeld airports, is due to start at 05:00 am (0400 GMT) and end at 8:45 am.Some 80 flights are expected to be affected, according to DPA news agency, mostly at the city’s main Tegel airport.German flagship carrier Lufthansa said it was cancelling four flights on its Berlin-Frankfurt route and four more between Berlin and Munich.The roughly 850 passengers booked on those flights could use their tickets to travel by train instead, Lufthansa added.”We regret that our passengers have to start the new year with disruptions,” Lufthansa board member Detlef Kayser told DPA.The strike comes after Verdi, which represents some 23,000 airport security workers nationwide, said talks with the BDLS employers’ association were deadlocked.The union wants to see wages raised to 20 euros ($23) per hour for workers carrying out passenger, freight, personnel and goods checks at German airports. Rates vary across the country but staff working in passenger security at Tegel and Schoenefeld currently earn an hourly rate of 17.12 euros.The employers’ association has offered wage increases of between 2.0 and 8.1 percent annually.The next round of talks is scheduled for January 23. Lufthansa has cancelled several flights because of the strike action Lufthansa cancels 800 flights Tuesday in German airport strikescenter_img Explore further Hundreds of German passengers were facing travel upheaval on Monday with security staff at Berlin’s two airports set to walk out in a pay dispute. This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.last_img read more

Adidas loses EU court battle over three stripe design

first_img The three parallel stripes seen adorning everything from running shoes to sports bags and the sleeves of t-shirts are “an ordinary figurative mark”, the General Court of the European Union ruled.The court, the EU’s second highest tribunal, upheld a 2016 ruling by the bloc’s intellectual property regulator cancelling the registration of the three-stripe design as a trademark following a challenge by a Belgian shoe company.”The General Court of the EU confirms the invalidity of the Adidas EU trade mark which consists of three parallel stripes applied in any direction,” the court said in a statement.Adidas had not proved the motif had acquired a “distinctive character” throughout the 28 countries of the bloc that would qualify for legal protection, the court said.”The mark is not a pattern mark composed of a series of regularly repetitive elements, but an ordinary figurative mark,” the court said.The ruling is the latest round in a long legal tussle between Adidas and Belgian rival Shoe Branding Europe, which as far back as 2009 won trademark status for a two-stripe design, triggering court action from the German firm.Adidas said in a statement it was “disappointed” with the ruling, but said it only applied to one specific version of the motif—three thick black lines in parallel separated by two thinner white lines.The ruling “does not impact on the broad scope of protection that Adidas has on its well-known 3-Stripe mark in various forms in Europe,” the company said.”Whilst we are disappointed with the decision, we are further evaluating it and are welcoming the useful guidance that the court will give us for protecting our 3-Stripe mark applied to our products in whichever direction in the future.”Adidas said it had not decided whether to appeal against Wednesday’s decision at the European Court of Justice, the bloc’s highest court. German sportswear giant Adidas on Wednesday lost a legal battle to trademark its “three stripe” motif in the EU, as a court ruled the design was not distinctive enough to deserve protection. Adidas won’t lose its stripes, but could lose the ability to prevent competitors from using similar designs in the EU Louboutin wins EU court battle over red-soled shoes © 2019 AFPcenter_img Citation: Adidas loses EU court battle over ‘three stripe’ design (2019, June 19) retrieved 17 July 2019 from https://phys.org/news/2019-06-adidas-eu-court-stripe.html This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only. Explore furtherlast_img read more

Naidu meets Deve Gowda for nonBJP coalition

first_img SHARE SHARE EMAIL national elections COMMENT Andhra Pradesh Chief Minister and Telugu Desam Party (TPD) leader N Chandrababu Naidu on Thursday met former Prime Minister and Janata Dal supermo HD Deve Gowda with a plan to stitch a non-BJP opposition coalition of regional parties for 2019 Lok Sabha elections.Naidu, who closeted with Deve Gowda and his son, Karnataka Chief Minister HD Kumaraswamy, for more than 45 minutes, discussed formation of a coalition of regional parties, economic scenario, and agrarian crisis plaguing the country.Addressing reporters after coming out of the meeting, Naidu said “People like us especially Deve Gowdaji, myself, Kumraswamiji and other leaders have joined together to save this nationDemocracy.“Our meet is an initial exercise to bring Opposition regional parties together. After that, we will work together. Even Mamata (Bannerjee) and honourable Chief Minister (HD Kumaraswamy) are holding rallies in January. How to work out the unification of the parties and how to go about thereafter, we will see in course of time,” he added.Talking about Prime Minister candidate, Naidu said, “PM candidate, we will decide. All of us will join together. First, our aim is to protect democracy and save nation. Congress is the main and major party and in Karnataka an experiment has been conducted under Deve Gowda ji.”Hinting at a 1996 model of forming the government at the Centre, Naidu said “A government with outside support of the Congress is possible. At that time, Third Front had come to power. Then we took the support from Congress from outside. That is the only the experiment.”He also alleged the government is using the CBI and income tax departments to control opposition and are raiding indiscriminately and harassing politicians.“All institutions are destroyed in the country. The CBI, a premier instiution for investigation of corruption, is in trouble. Who is responsible? Even RBI, an autonomous body, is under threat,” he said.Andhra Pradesh Chief Minister said prime ministerial candidate will be decided at later stage. Says govt with outside support of the Congress is possible national politics Published on SHARE November 08, 2018 Andhra Pradesh Chief Minister Chandrababu Naidu with Janata Dal(S) supremo HD Deve Gowda in Bengaluru   –  K MURALI KUMAR COMMENTSlast_img read more