Spartan Bioscience Announces 6,000-Patient Study of Personalized Medicine for Cardiac Stents

Landmark clinical trial begins for rapid DNA testing and personalized anti-blood clotting drugs.

Ottawa, Ontario (PRWEB) December 20, 2012

Spartan Bioscience today announced the start of a 5,945-patient study of personalized medicine for cardiac stent patients. The study is sponsored by the Center for Individualized Medicine at Mayo Clinic and is entitled “Tailored Antiplatelet Initiation to Lessen Outcomes due to Clopidogrel Resistance after Percutaneous Coronary Intervention (TAILOR-PCI).”

This clinical trial will evaluate whether genotyping of cardiac stent patients at the time of angioplasty can help improve patient outcomes by informing providers about drug selection of either Brilinta® (ticagrelor) or Plavix® (clopidogrel). These antiplatelet drugs are prescribed after surgery to reduce clotting complications, such as heart attacks, strokes, and cardiovascular deaths. The drugs are thought to work differently in patients with specific variations in the CYP2C19 gene, and the Spartan RX CYP2C19 rapid DNA testing system will be used to identify these variations in some patients of the TAILOR-PCI study. The study will enroll patients over a 22-month period at 9 hospitals in Canada and the United States.

The principal investigator of the TAILOR-PCI study is Naveen Pereira, M.D., a Mayo Clinic cardiologist. Chiranjit Rihal, M.D., chairman of the Division of Cardiovascular Diseases at Mayo Clinic in Rochester, Minnesota, serves as chairman of the TAILOR-PCI steering committee. The Mayo Clinic sites are Rochester; Jacksonville, Florida; Phoenix, Arizona; and the Mayo Clinic Health Systems in La Crosse, Wisconsin; and Mankato, Minnesota. Canadian sites participating in this study are St. Michael’s Hospital, Toronto General Hospital, Sunnybrook Hospital, and the University of Ottawa Heart Institute.

“We are excited to work with Mayo Clinic on this landmark clinical trial,” said Paul Lem, M.D., CEO of Spartan Bioscience. “Rapid DNA testing means doctors and patients do not have to wait days or weeks for results from a central lab.”

About the Spartan RX CYP2C19

The Spartan RX CYP2C19 is the first point-of-care DNA test in medicine.(1) It identifies carriers of certain CYP2C19 genetic mutations in 1 hour. These mutations are carried by approximately 30 percent of the world’s population.(2) Genetic carriers who receive Plavix® following a cardiac stent insertion to open clogged arteries have a 42 percent higher risk of death, stroke, or heart attack in the first year compared to non-carriers.(3) Currently, genetic testing is performed in central labs and it takes up to seven days to get a test result back. A rapid test is needed because most of the complications for CYP2C19 carriers occur in the first 24 to 48 hours.(3,4) In March 2010, the FDA issued a warning for Plavix regarding CYP2C19 poor metabolizers. The Spartan RX CYP2C19 has CE IVD Mark regulatory approval for Europe and other countries recognizing the CE IVD Mark. Spartan Bioscience is working towards FDA 510(k) clearance in the United States. For more information, please visit our website at: http://www.spartanbio.com/products/spartan-rx

About Spartan Bioscience

Spartan Bioscience is the leader in point-of-care DNA testing. The Spartan RX is the first complete sample-to-result, point-of-care DNA testing system in medicine. It is a fully integrated DNA collection, extraction and analysis platform, with an intuitive interface that is easy to operate—no laboratory training required. For the first time, healthcare providers and their patients can get DNA results on demand. For more information, please visit our website at: http://www.spartanbio.com.

The Spartan logo is a registered trademark of Spartan Bioscience Inc.

Brilinta is a registered trademark of AstraZeneca.

Plavix is a registered trademark of Bristol-Myers Squibb/Sanofi Pharmaceuticals.

1. Roberts JD et al. (2012). Lancet. 379: 1705–1711.

2. Damani SB, Topol EJ. (2010). J Am Coll Cardiol. 56:109–111.

3. Mega JL et al. (2009). N Engl J Med. 360:354–362.

4. Wiviott SD et al. (2007). N Engl J Med. 357:2001–2015.

Paul Lem, M.D.
Spartan Bioscience Inc.
+1 (613) 228-7756 735
Email Information

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Google launches ‘scan and match’ music service

LOS ANGELES (AP) — Google is turning on a “scan and match” service for Google Music users to store copies of their songs online, offering for free what Apple charges $ 25 a year for.

The service, which launched Tuesday, cuts uploading time for those who want to save their music libraries online. It scans a user’s computer and gives them online access to the songs it finds, as long as they match the songs on its servers. Otherwise, it will upload songs to a user’s online locker.

The service is similar to Apple Inc.‘s iTunes Match, which includes online storage for 25,000 songs. Google Inc. allows storage for 20,000 songs and allows users to re-download the songs only at the same quality as they were at previously. Apple upgrades songs to iTunes quality.

Amazon runs a similar matching and uploading service called Cloud Player. It costs $ 25 a year for 250,000 songs. A free version is limited to 250 songs.

Google is still a fledgling entrant into music sales since debuting its store in November 2011, though it expects to benefit from the hundreds of millions of devices that use its Android operating system on mobile devices.

According to the NPD Group, Apple accounted for 64 percent of U.S. music sales online, followed by Amazon at 16 percent. Google has no more than 5 percent, according to NPD. Other services make up the rest.

Google had sold songs at a discount at the start, but that is less so the case now. For example, it was selling the top-ranked Bruno Mars song “Locked Out of Heaven” for $ 1.29 on Wednesday, the same as iTunes, and above the 99 cents on Amazon. But its album price was lower at $ 10.49 versus $ 10.99 at both iTunes and Amazon.

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Worries grow in east Congo with fighter buildup

DAKAR, Senegal (AP) — Aid workers warned Wednesday that armed groups are setting up new front lines in and around the city of Goma in eastern Congo, where the U.N. said it now has documented at least 126 rape cases last month.

Thousands of fighters from the M23 rebel group withdrew several weeks ago from Goma, and the fighters have since taken steps toward negotiating with the Congolese government.

However, residents in Goma say M23 and other armed fighters are now positioning themselves in an around the city — including inside camps for people displaced by the violence.

The arrival of several thousand fighters within the last week is prompting fear among civilians, who already have experienced years of fighting and rebellions, said Tariq Riebl, Oxfam’s humanitarian coordinator there.

“They are very concerned — people are seeing this and they don’t know what it means,” he said. “I think what everyone is scared about is that it seems like people are ramping up, ramping up but for what purpose?”

Oxfam warns that more than 1 million people could come under attack if violence again flares in Goma, where more than 100,000 people already have fled from elsewhere in the region.

“Goma is typically the last refuge safe haven and now it’s being directly called into question. If Goma falls in a big battle, where are people going to go?” Riebl said.

“This is very, very disconcerting because you have a population of over 1 million people and if war were to break out, we’re looking at a horrific situation.”

The M23 rebel group, which is believed to be backed by neighboring Rwanda, is made up of hundreds of soldiers who deserted the Congolese army in April.

They took control of many villages and towns in the mineral-rich east over the last seven months, culminating in the seizure of Goma on Nov. 20. It took days of negotiations and intense international pressure, including from the U.N., for the thousands of fighters from M23 to finally withdraw from the regional capital.

The U.N. mission says it’s received allegations of serious rights violations, including killings and wounding of civilians, rape, looting, and forced recruitment of children, by elements of the M23 rebels in Goma and neighboring areas.

Congo’s armed forces are also blamed for a series of attacks as they fled Goma in retreat in late November.

The U.N. said Tuesday it now has been able to document at least 126 rapes during that period in the Minova area, about 60 kilometers (40 miles) south of Goma.

U.N. spokesman Martin Nesirky said that two Congolese soldiers so far have been arrested in connection with the rapes, while seven others had been implicated in looting in the area.

“The Congolese Armed Forces have started investigating those human rights violations,” he said. “The U.N. Mission is supporting the military justice procedure in conducting thorough investigations into these allegations to ensure that the perpetrators are identified and held accountable.”

Rape has long been used as a brutal weapon of war in eastern Congo, where both soldiers and various armed groups use sexual violence to intimidate, punish and control the population.

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“Ai Weiwei: Never Sorry,” “Bully” first theatrical releases to win duPont awards

LOS ANGELES (TheWrap.com) – Two documentary films were among the 14 winners of the 2013 Alfred I. duPont-Columbia University Award, making them the first theatrical releases to be honored with the prize. USA Today also won its first duPont award.

“Ai Weiwei: Never Sorry,” Alison Klayman‘s profile of the Chinese artist-activist, and Emmy-winning filmmaker Lee Hirsch‘s tale of schoolyard torment, “Bully,” won alongside reporting from Current TV, CBS News, NPR, PBS’s “Frontline” and USA Today.

USA Today was honored for multimedia reporting on abandoned lead factories, and NPR’s “StoryCorps” will win its first silver baton.

Five awards will go to local television and radio stations: KCET in Southern California, KLAS-TV in Las Vegas, WVUE-TV in New Orleans, Detroit’s WXYZ-TV and partnerships with WHYY and NPR.

“This exceptional group of journalists represents the best of broadcast, documentary and digital news reporting today,” Bill Wheatley, the outgoing duPont Jury chair and the former executive vice president of NBC News, said in a statement. “These groundbreaking stories set the standard for excellent reporting; journalists gained access and insight into critical issues in the public interest, and they are telling these important stories in new ways.”

Christiane Amanpour, CNN’s chief international correspondent and a global affairs anchor for ABC News will present the awards with CBS News’s Byron Pitts on Tuesday, January 22, 2013 at Columbia’s Low Memorial Library.

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Obama: 'Words need to lead to action' on gun control

WASHINGTON (AP) — Spurred by a horrific elementary school shooting, President Barack Obama tasked his administration Wednesday with creating concrete proposals to reduce gun violence that has plagued the country.

"This time, the words need to lead to action," said Obama, who set a January deadline for the recommendations. He vowed to push for their implementation without delay.

The president, who exerted little political capital on gun control during his first term, also pressed Congress to reinstate an assault weapons ban, which expired in 2004. He also called for stricter background checks for people who seek to purchase weapons and limited high capacity clips.

"The fact that this problem is complex can no longer be an excuse for doing nothing," Obama said. "The fact that we can't prevent every act of violence doesn't mean we can't steadily reduce the violence."

Obama's announcement Wednesday underscores the urgency the White House sees in formulating a response to the shooting in Newtown, Conn. Twenty children and six adults were killed when a man carrying a military-style rifle stormed an elementary school.

The massacre has prompted several congressional gun rights supporters to consider new legislation to control firearms, and there is some concern that their willingness to engage could fade as the shock and sorrow over the Newtown shooting eases.

Obama said Wednesday it was "encouraging" to see people of different backgrounds and political affiliations coming to an understanding that the country has an obligation to prevent such violence.

Appealing to gun owners, Obama said he believes in the Second Amendment and the country's strong tradition of gun ownership. And he said "the vast majority of gun owners in America are responsible."

The president tasked Vice President Joe Biden with leading the administration-wide effort to create new gun control policies. Obama also wants his team to consider ways to improve mental health resources and address ways to create a culture that doesn't promote violence.

The departments of Justice, Education, Health and Human Services, and Homeland Security will all be part of the process.

Biden's prominent role in the process could be an asset for the White House in getting gun legislation through Congress. The vice president spent decades in the Senate and has been called on by Obama before to use his long-standing relationships with lawmakers to build support for White House measures.

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Court approves Amgen’s $762 million payment in drug case

NEW YORK (Reuters) – A federal judge on Wednesday approved a $ 762 million payment from Amgen Inc, the final step to resolve nearly a dozen criminal and civil cases stemming from the sale of its once-blockbuster anemia drug Aranesp and several others.

Prosecutors previously said in Brooklyn federal court on Tuesday the company had agreed to pay $ 612 million in a civil settlement, a $ 14 million criminal forfeiture payment, and a $ 136 million criminal fine. It is the single largest criminal and civil fraud settlement involving a biotechnology company in U.S. history, according to the U.S. attorney’s office in Brooklyn.

Amgen pleaded guilty on Tuesday to one misdemeanor criminal count that it promoted Aranesp for higher, less frequent doses than approved in the drug’s label by federal regulators. The company was also accused of marketing the drug to treat anemia caused by cancer, for which it was not approved, rather than to combat anemia as a side effect of chemotherapy treatments.

Amgen recorded a $ 780 million charge in the third quarter of 2011 to resolve civil and criminal litigation. In a recent regulatory filing with the U.S. Securities and Exchange Commission, Amgen said it had set aside $ 806 million related to the proposed settlement of charges arising out of the federal civil and criminal investigations.

U.S. District Judge Sterling Johnson accepted the company’s plea on Wednesday and approved its plea agreement with the government. The agreement includes a call for Amgen to abide by a five-year corporate integrity agreement, which imposes new compliance, transparency and accountability measures on the company’s top executives and directors.

The agreement resolves a more than five-year investigation by the U.S. attorney’s office in Brooklyn, as well as a related investigation by federal prosecutors in Washington state, according to court papers.

“Instead of working to extend and enhance human lives, Amgen illegally pursued corporate profits while jeopardizing the safety of vulnerable consumers suffering from disease,” acting U.S. attorney Marshall Miller of the Eastern District of New York said in a statement.

Details of the $ 612 million civil portion of the settlement were also unsealed Wednesday, encompassing a wider scope of allegations than the criminal case. The civil settlement resolves 10 whistleblower lawsuits from Brooklyn, Massachusetts and Washington federal courts, prosecutors said.

The civil settlement covers allegations that Amgen market Aranesp and two other drugs, Enbrel and Neulasta, for uses and doses that had not been approved. The company was also accused of offering illegal kickbacks to try to persuade health-care providers to prescribe their drugs, and engaged in false price reporting practices, federal prosecutors said.

Other Amgen drugs named in the civil suits include Epogen, Neupogen and Sensipar, according to court papers.

“The government raised important concerns in the criminal prosecution,” Amgen chief compliance officer Cynthia Patton said in a statement. “Amgen acknowledges that mistakes were made, and we did not live up to our standards.”

Amgen shares were down 53 cents to $ 88.76 in midafternoon trading.

(Reporting by Jessica Dye; Editing by Neil Stempleman)

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New Android botnet discovered across all major networks

A new Android spam botnet has been discovered across all major networks that sends thousands of text messages without a user’s permission, TheNextWeb reported. The threat, which is known at SpamSoldier, was detected on December 3rd by Lookout Security in cooperation with an unnamed carrier partner. The malware is said to spread through a collection of infected phones that send text messages, which usually advertise free versions of popular paid games like Grand Theft Auto and Angry Birds Space, to hundreds of users each day.

[More from BGR: Facebook’s Instagram monetization plan: License users’ photos without paying for them]

Once a user clicks on the link to download the game, his or her phone instead downloads the malicious app. When the app is downloaded, SpamSoilder removes its icon from the app drawer, installs a free version of the game in question and immediately starts sending spam messages.

[More from BGR: How not to fix Apple Maps]

The security firm notes that the threat isn’t widespread, however it has been spotted on all major carriers in the U.S. and has potential to do serious damage if something isn’t done soon to stop it.

This article was originally published by BGR

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NRA breaks silence on 'horrific' massacre

Tasha Devoe, left, of Lawrence, Mass., joins a march to NRA headquarters in Washington on Dec. 17, 2012. (Manuel …The National Rifle Association on Tuesday broke its silence on last Friday's mass shooting at Sandy Hook Elementary School in Newtown, Conn., denouncing the "horrific and senseless murders" and vowing to "help make sure this never happens again."

Facing a fierce push for new restrictions on gun ownership in the tragedy’s aftermath, the group said it would hold "a major news conference" in Washington on Friday. It did not elaborate.

"The National Rifle Association of America is made up of four million moms and dads, sons and daughters—and we were shocked, saddened and heartbroken by the news of the horrific and senseless murders in Newtown," the organization said in a statement emailed to reporters.

"The NRA is prepared to offer meaningful contributions to help make sure this never happens again," it said.

In keeping with its past practice after other mass shootings, the NRA kept quiet after the killings of 20 children and six adults at the school, plus the gunman's mother. Gun control advocates, however, have ramped up calls for new restrictions to prevent such tragedies from occurring in the future. And President Barack Obama himself has called for a strong response to the massacre.

"Out of respect for the families, and as a matter of common decency, we have given time for mourning, prayer and a full investigation of the facts before commenting," the NRA said in its statement.

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CBS dominates week in TV ratings

NEW YORK (AP) — CBS had little competition for dominance last week in the television ratings.

The network had 17 of the 25 most-watched programs on the air last week, according to the Nielsen company. It beat second-place NBC by an average of nearly four million viewers a night last week, and also took the 18-to-49-year-old demographic that advertisers seek.

“60 Minutes” and “NCIS” were the most popular shows on CBS last week. As is typical in the fall, NBC‘s Sunday night football matchup was the week’s most-watched show.

One end-of-year tradition, Barbara Walters‘ survey of the year’s most popular personalities, finished No. 27 in the week’s ratings with 7.6 million viewers.

On cable, Showtime’s “Dexter” and “Homeland” both hit series records for their season finale episodes on Sunday. “Dexter” had 2.8 million viewers and “Homeland” had 2.3 million. Showtime preceded each episode with a disclaimer, warning that audiences might find the shows too intense so soon after the Connecticut school killings.

CBS averaged 11.9 million viewers for the week in prime time (7.3 rating, 12 share). NBC had 7.3 million (4.5, 7), ABC had 5.1 million (3.3, 5), Fox had 4.4 million (2.7, 4), the CW had 1.7 million (1.1, 2) and ION Television had 1.3 million (0.9, 1).

Among the Spanish language networks, Univision led with an average of 3.2 million viewers (1.7, 3). Telemundo had 1.3 million (0.7, 1), TeleFutura had 850,000 (0.4, 1), Estrella had 340,000 (0.2, 0) and Azteca had 140,000 (0.1, 0).

NBC‘s “Nightly News” topped the evening newscasts with an average of 9.4 million viewers (6.3, 12). ABC’s “World News” was second with 8.3 million (5.5, 11) and the “CBS Evening News” had 7.2 million viewers (4.9, 9).

A ratings point represents 1,147,000 households, or 1 percent of the nation’s estimated 114.7 million TV homes. The share is the percentage of in-use televisions tuned to a given show.

For the week of Dec. 10-16, the top 10 shows, their networks and viewerships: NFL Football: San Francisco at New England, NBC, 23.23 million; “60 Minutes,” CBS, 19.63 million; “NCIS,” CBS, 17.65 million; “The Big Bang Theory,” CBS, 16.74 million; “NCIS: Los Angeles,” CBS, 15.12 million; “Sunday Night NFL Pre-Kick,” NBC, 14.62 million; “Person of Interest,” CBS, 14.08 million; “Two and a Half Men,” CBS, 13.34 million; “The Voice” (Monday), NBC, 12.33 million; “Criminal Minds,” CBS, 12.01 million.

___

ABC is owned by The Walt Disney Co. CBS is owned by CBS Corp. CW is a joint venture of Warner Bros. Entertainment and CBS Corp. Fox and My Network TV are units of News Corp. NBC and Telemundo are owned by Comcast Corp. ION Television is owned by ION Media Networks. TeleFutura is a division of Univision. Azteca America is a wholly owned subsidiary of TV Azteca S.A. de C.V.

___

Online:

http://www.nielsen.com

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NBC’s Engel, TV crew escape abduction in Syria

BEIRUT (AP) — NBC‘s chief foreign correspondent Richard Engel said Tuesday he and members of his network crew escaped unharmed after five days of captivity in Syria, where more than a dozen pro-regime gunmen dragged them from their car, killed one of their rebel escorts and subjected them to mock executions.

Appearing on NBC’s “Today” show, an unshaven Engel said he and his team escaped during a firefight Monday night between their captors and rebels at a checkpoint. They crossed into Turkey on Tuesday.

NBC did not say how many people were kidnapped with Engel, although two other men, producer Ghazi Balkiz and photographer John Kooistra, appeared with him on the “Today” show. It was not confirmed whether everyone was accounted for.

Engel said he believes the kidnappers were a Shiite militia group loyal to the Syrian government, which has lost control over swaths of the country’s north and is increasingly on the defensive in a civil war that has killed 40,000 people since March 2011.

“They kept us blindfolded, bound,” said the 39-year-old Engel, who speaks and reads Arabic. “We weren’t physically beaten or tortured. A lot of psychological torture, threats of being killed. They made us choose which one of us would be shot first and when we refused, there were mock shootings,” he added.

“They were talking openly about their loyalty to the government,” Engel said. He said the captors were trained by the Iranian Revolutionary Guard and allied with Hezbollah, the Lebanese Shiite militant group, but he did not elaborate.

There was no mention of the kidnapping by Syria’s state-run news agency.

Both Iran and Hezbollah are close allies of the embattled Syrian government of President Bashar Assad, who used military force to crush mostly peaceful protests against his regime. The crackdown on protests led many in Syria to take up arms against the government, and the conflict has become a civil war.

Engel said he was told the kidnappers wanted to exchange him and his crew for four Iranian and two Lebanese prisoners being held by the rebels.

“They captured us in order to carry out this exchange,” he said.

Engel and his crew entered Syria on Thursday and were driving through what they thought was rebel-controlled territory when “a group of gunmen just literally jumped out of the trees and bushes on the side of the road.”

“There were probably 15 gunmen. They were wearing ski masks. They were heavily armed. They dragged us out of the car,” he said.

He said the gunmen shot and killed at least one of their rebel escorts on the spot and took the hostages into a waiting truck nearby.

Around 11 p.m. Monday, Engel said he and the others were being moved to another location in northern Idlib province.

“And as we were moving along the road, the kidnappers came across a rebel checkpoint, something they hadn’t expected. We were in the back of what you would think of as a minivan,” he said. “The kidnappers saw this checkpoint and started a gunfight with it. Two of the kidnappers were killed. We climbed out of the vehicle and the rebels took us. We spent the night with them.”

Engel and his crew crossed back into neighboring Turkey on Tuesday.

The network said there was no claim of responsibility, no contact with the captors and no request for ransom during the time the crew was missing.

NBC sought to keep the disappearance of Engel and the crew secret for several days while it investigated what happened to them. Major media organizations, including The Associated Press, adhered to a request from the network to refrain from reporting on the issue out of concern it could make the dangers to the captives worse. News of the disappearance did begin to leak out in Turkish media and on some websites on Monday.

Syria has become a danger zone for reporters since the conflict began.

According to the Committee to Protect Journalists, Syria is by far the deadliest country for the press in 2012, with 28 journalists killed in combat or targeted for murder by government or opposition forces.

Among the journalists killed while covering Syria are award-winning French TV reporter Gilles Jacquier, photographer Remi Ochlik and Britain’s Sunday Times correspondent Marie Colvin. Also, Anthony Shadid, a correspondent for The New York Times, died after an apparent asthma attack while on assignment in Syria.

The Syrian government has barred most foreign media coverage of the civil war in Syria. Those journalists whom the regime has allowed in are tightly controlled in their movements by Information Ministry minders. Many foreign journalists sneak into Syria illegally with the help of smugglers and travel with rebel escorts or drivers.

Engel joined NBC in 2003 and was named chief foreign correspondent in 2008. He previously worked as a freelance journalist for ABC News, including during the U.S. invasion of Iraq. He has lived in the Middle East since graduating from Stanford University in 1996.

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