Wednesday, July 6, 2016

White House proposes measures to speed genomic test development

WASHINGTON: The White House announced on Wednesday measures aimed at advancing President Barack Obama's precision medicine initiative, including plans to speed the development of tests used to identify genetic mutations and guide medical treatment.

The US Food and Drug Administration said it planned to issue a proposal on Wednesday to create performance standards to guide development of next generation sequencing (NGS) tests. These tests scan a person's DNA and identify genetic differences that could be responsible for a patient's symptoms.

The standards would be designed to assess how accurately a test identifies a genetic variant. The developer would certify that it had met those standards. Currently the FDA itself determines the test's accuracy.

"We believe that the use of standards is the best way to allow regulation to keep pace with the evolution of NGS technology," Dr. Robert Califf told reporters on a conference call.

A second FDA proposal would allow test developers to use data from publicly accessible genetic databases, not just their own data, to demonstrate that the test accurately predicts disease. Califf said the approach could potentially get rid of the need for the FDA to review the tests before they reach the market.

"Taken together, these guidances will foster innovation, assure the quality and reliability of NGS-based tests and promote their adoption into clinical practice," he said.

The FDA's action is part of a broader government initiative to promote the development of individually tailored medicines. Obama introduced the initiative in his State of the Union address last year, saying he wanted the United States to lead a new era of medicine, "one that delivers the right treatment at the right time."

As part of the project, the National Institutes of Health will invest $55 million to build the infrastructure needed to collect genetic data from more than 1 million volunteers, its director, Dr. Francis Collins, said on the conference call.

Collins said it will take three to four years to assemble the desired amount of genetic material, which will then be available to researchers to help develop drugs for cancer and other disease. Anyone, he said, can participate.

"This is about all of us," he said. "Participants will be true partners, not subjects, not patients." Data sharing, he added, will be "swift."

Policeman dead after blast at Bangladesh Eid prayers

Dhaka: At least one policeman was killed and five others wounded Thursday after a small bomb exploded near a mass Eid prayer congregation in Bangladesh, police said.

Police and local media said the explosion occurred at a school outside the prayer ground in the northern Kishoreganj district where at least 200,000 people were gathered. There were also exchanges of gunfire at the scene.

"One police constable is dead and at least five others were injured," Mahbub, a police officer in the Kishoreganj control room, told AFP.

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Modi calls PM Nawaz on Eid, wishes him well post-surgery

ISLAMABAD: Indian Prime Minister Narendra Modi telephoned his Pakistani counterpart Nawaz Sharif on Wednesday, the holiday of Eid, to wish him a speedy recovery from surgery, a sign the two men remain in touch, despite fraught diplomatic relations.

Sharif, 66, had successful open heart surgery in a London hospital in May, his second cardiac procedure in five years.

"Indian Prime Minister Modi called Prime Minister Sharif on the occasion of Eid," Sharif´s office said in a statement.

"He also wished him well for his health post-surgery."

Wednesday is a national holiday in Pakistan, marking the end of the holy month of Ramazan, when Muslims fast from dawn till dusk.

Before the surgery in May, Sharif had also telephoned Modi to thank him for his wishes for a quick recovery.

Sharif made a bid to improve ties with old rival India a key plank of his 2013 election campaign, though progress has been slow and relations remain frayed over militant attacks and long-standing distrust.

Modi calls PM Nawaz on Eid, wishes him well post-surgery

ISLAMABAD: Indian Prime Minister Narendra Modi telephoned his Pakistani counterpart Nawaz Sharif on Wednesday, the holiday of Eid, to wish him a speedy recovery from surgery, a sign the two men remain in touch, despite fraught diplomatic relations.

Sharif, 66, had successful open heart surgery in a London hospital in May, his second cardiac procedure in five years.

"Indian Prime Minister Modi called Prime Minister Sharif on the occasion of Eid," Sharif´s office said in a statement.

"He also wished him well for his health post-surgery."

Wednesday is a national holiday in Pakistan, marking the end of the holy month of Ramazan, when Muslims fast from dawn till dusk.

Before the surgery in May, Sharif had also telephoned Modi to thank him for his wishes for a quick recovery.

Sharif made a bid to improve ties with old rival India a key plank of his 2013 election campaign, though progress has been slow and relations remain frayed over militant attacks and long-standing distrust.

US to keep 8,400 troops in Afghanistan into 2017: Obama

WASHINGTON: President Barack Obama announced Wednesday that 8,400 US troops will remain in Afghanistan into 2017 in light of the still "precarious" security situation in the war-ravaged country.

"Instead of going down to 5,500 troops by the end of this year, the United States will maintain approximately 8,400 troops in Afghanistan into next year through the end of my administration," Obama told a news conference.

"The decision I´m making today ensures my successor has a solid foundation for continued progress in Afghanistan, as well as the flexibility to address the threat of terrorism as it evolves," he said.

The current number of US troops in Afghanistan is 9,800.

Obama´s announcement is further acknowledgement that Afghan security forces, who took charge of the country´s security in 2015, are still not ready to go it alone.

They have suffered a devastating string of setbacks at the hands of the Taliban, including the temporary loss of the city of Kunduz, and more than 5,000 Afghan troops were killed last year alone.

Other organizations, including the Daesh (Islamic State group), have also stepped up activity.

"The security situation in Afghanistan remains precarious," Obama said.

"Even as they improve, Afghan security forces are still not as strong as they need to be. With our help, they´re still working to improve critical capabilities, such as intelligence, logistics, aviation and command and control."

Obama´s decision comes after General John Nicholson, the new commander of the US-led NATO mission in Afghanistan, this year conducted a review of the security situation.

Republican Senator John McCain, a longtime critic of Obama´s military policies, praised the move, but said the president should have kept the entire 9,800 US troops in country.

Still, he said, "the decision to retain 8,400 US troops in Afghanistan into next year is certainly preferable to cutting those forces by nearly half."

PM to return on Saturday after doctors? green signal

ISLAMABAD: Prime Minister Nawaz Sharif will return to Pakistan on Saturday after the doctors in London allowed him to travel after his heart surgery, sources said Wednesday.

According to the sources, the Premier will arrive in Lahore via special plane after he insisted to his doctors’ in London to grant him permission return to the motherland.

Nawaz Sharif’s brother and Chief Minister Punjab Shahbaz Sharif, Hamza Shahbaz and others will accompany the PM, the sources further said.

PM Nawaz underwent open heart surgery in a London hospital on May 31, his second cardiac procedure in five years.

 

PM to return on Saturday after doctors? green signal

ISLAMABAD: Prime Minister Nawaz Sharif will return to Pakistan on Saturday after the doctors in London allowed him to travel after his heart surgery, sources said Wednesday.

According to the sources, the Premier will arrive in Lahore via special plane after he insisted to his doctors? in London to grant him permission return to the motherland.

Nawaz Sharif?s brother and Chief Minister Punjab Shahbaz Sharif, Hamza Shahbaz and others will accompany the PM, the sources further said.

PM Nawaz underwent open heart surgery in a London hospital on May 31, his second cardiac procedure in five years.

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