Qiagen launches new breast cancer test in Europe

QIAGEN N.V. (NYSE:QGEN) announces CE Mark certification of its therascreen PIK3CA RGQ PCR kit as an aid in identifying breast cancer patients with a PIK3CA mutation. Market launch is underway.

The FDA approved the test last year. It is used as a companion diagnostic for Novartis’ Piqray (alpelisib).

https://seekingalpha.com/news/3537588-qiagen-launches-new-breast-cancer-test-in-europe

US NIH cancels trial after finding vaccine doesn’t prevent HIV

• The National Institutes of Health on Monday discontinued a South African trial of an HIV vaccine regimen after data monitors concluded the treatment hadn’t prevented new infections.
• The HTVN 702 study stopped dosing following an interim analysis that was conducted when at least 60% of patients had been in the trial for 18 months. In the group given the vaccine, 129 patients were infected with HIV, while 123 were infected in the trial’s placebo arm.
• “We hoped this vaccine candidate would work. Regrettably, it does not,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a statement.

Worldwide, 38 million people are infected with HIV and nearly 2 million new infections happen every year. While effective treatments have been developed that prevent infections from progressing to AIDS, more than 700,000 people died from AIDS-related diseases in 2018.
Researchers hope a vaccine could prevent new infections, but the regimen tested in the Phase 2b/3 study, also known as Uhambo, did not live up to those hopes. The interim analysis consisted of data from 2,694 patients who received the active treatment and 2,689 patients who had been given a placebo, allowing the trial’s data safety and monitoring board to draw its conclusion.
The board did not find any safety signals.
When the NIH initiated the trial in 2016, it said the vaccine regimen was the only one ever shown to provide some protection against HIV, citing results from a Thai study.
Researchers based the regimen used in the trial on work conducted by the U.S. Military HIV Research Program and the Thai Ministry of Health in a trial called RV144. In the South African study, the vaccine was adapted to protect against the virus most common there, an HIV subtype called Clade C.
The regimen consisted of a Sanofi Pasteur-supplied, canarypox-based vaccine, dubbed ALVAC-HIV, and a GlaxoSmithKline gp120 protein subunit vaccine with an immunity-boosting adjuvant, both modified to be specific to subtype C. Those two shots were followed with boosters at 12 and 18 months.
An earlier trial of this regimen had shown that it stimulated antibodies to several HIV strains. However, that biomarker finding was not confirmed as having a benefit in preventing infections.
Johnson & Johnson and NIH have initiated a Phase 3 trial of another two-vaccine regimen that aims to cover a number of HIV subtypes. Called MOSAICO, that trial will also use HIV infection rates as its primary measure and is scheduled to yield final results in 2023.
https://www.biopharmadive.com/news/nih-stop-hiv-vaccine-study-uhambo/571594/

High-Tech Machines Are Being Used To Contain The Wuhan Coronavirus

When doctors in a Washington hospital sought to treat the first confirmed case of the Wuhan coronavirus in the United States on Wednesday, they tapped a device called Vici that allowed them to interact with their patient not in person, but through a screen.

The telehealth device, which looks like a tablet on wheels that doctors can use to talk to patients and perform basic diagnostic functions, like taking their temperature, is one of a handful of high-tech machines that doctors, airport workers, and hotel staff are using to help contain the outbreak that has been sweeping the world since it was discovered in Wuhan, China in late December.
“Caregivers provide care within the isolation unit, but technology is allowing us to reduce the number of up-close interactions,” says Dr. Amy Compton-Phillips, chief clinical officer at Providence Regional Medical Center in Everett, Washington, where the patient is being treated. Vici, made by Santa Barbara, California-based InTouch Health, resembles a tablet on wheels, and can protect caregivers from infection.

“Minimizing the spread of this new virus is especially important because we have not yet built up any immunity to it,” Compton-Phillips says. During the SARS coronavirus outbreak in 2003, a large portion of those affected were healthcare workers, highlighting the difficulties of remaining safe while providing treatment.
China’s national health commission and the Centers for Disease Control and Prevention say that the infection can spread from person-to-person, making telehealth devices and robots that minimize human contact in hospitals potentially life-saving.

“If it’s not essential for certain supporting staff to be in the patient areas, it’s best for them to avoid it. The fewer people who are in contact with infected patients, the better,” says Peter Seiff, an executive at Aethon, a Pittsburgh-based private company that sells a robot called TUG that autonomously ferries medical supplies throughout hospitals.

The Vici telehealth device and TUG robot are being used in hospitals across the United States.

Courtesy of InTouch Health and Aethon

Aethon’s TUG robots are deployed at over 140 sites, though the company wouldn’t comment on whether the device is being used at any of the U.S. hospitals where more than 240 patients have been investigated for the novel coronavirus that has so far killed at least 200 people in China.
There, robots are delivering both food and medical supplies to people suspected of having the virus, according to Chinese news reports. A robot named Little Peanut is delivering meals to people in quarantined in a hotel, while a hospital in southern China has rolled out bots to deliver medicine and collect bed sheets and rubbish.
Beyond delivery and telehealth, there’s surging demand for cleaning and disinfecting robots. Xenex, a San Antonio, Texas-based company that sells robots that use pulsed xenon UV-C light to wipe out pathogens, says its devices are currently being used to clean rooms at facilities with suspected cases of the Wuhan coronavirus.
“Our science team has been on the phone non-stop with hospitals to discuss protocols for disinfecting rooms and areas where suspect patients have been and are being treated,” says spokesperson Melinda Hart. “We’ve also been in contact with government contacts in China and the U.S. to explore how quickly we could export robots to China.”
The devices, which cost about $100,000, have been shown to decrease health care-associated infections —those which are contracted while a person is receiving care for something else — in several individual hospital studies, done in collaboration with the company.
Meanwhile, a Los Angeles-based company called Dimer has offered one of its germ-killing machines to an airline at the city’s international airport for free. Normally, the “GermFalcon” devices sell for $100,000 per unit.

Dimer’s GermFalcon in action on an airplane at LAX.

Courtesy of Dimer

“We have been disinfecting inbound planes from China at LAX the last several days,” says president Elliot M. Kreitenberg. “Our machine fits in the interior of a plane like a puzzle piece and delivers high doses of ultraviolet light to the surfaces that you are most in contact with in a long haul flight.”
While machines to help contain a virus’s spread are much more common now than they were during the 2003 SARS epidemic, the Wuhan coronavirus has already spread faster.
https://www.forbes.com/sites/jilliandonfro/2020/02/02/robots-to-the-rescue-how-high-tech-machines-are-being-used-to-contain-the-wuhan-coronavirus/#3a70f1c81779

No, The Wuhan Virus Was Not Genetically Engineered To Put Pieces Of HIV In It

The Wuhan coronavirus has saturated news, social media and conversations around the world for the past few weeks. And people understandably have questions such as; masks to wear or not to wear? Or, will the flu shot protect you from coronavirus? No. Is the coronavirus anything to do with Corona beer? No, come on. But with so much focus on the topic and new information about the outbreak coming out constantly, inevitably a slew of spurious information is also flooding the internet and coronavirus has resulted in several, well…viral news stories with little scientific merit.

The newest of these was a little unusual because it was based on a pre-print of a real scientific paper, (since removed just a few hours ago) uploaded to website bioRxiv, where scientists can present their completed, or near-completed studies, prior to peer-review by other scientists. The work, by a group based in India, was entitled “Uncanny similarity of unique inserts in the 2019-nCoV spike protein to HIV-1 gp120 and Gag.”
Seeing HIV and coronavirus in the same sentence is understandably a little startling, so what does it actually mean?
“Based on analysis of multiple, very short regions of proteins in the novel coronavirus, the bioRxiv paper claimed that the new coronavirus may have acquired these regions from HIV,” said Arinjay Banerjee, PhD, a postdoctoral fellow in virology at McMaster University in Ontario, Canada who has extensively studied coronaviruses.

Some types of viruses can swap pieces of their genetic code and in this case,the authors of the study say that the specific coronavirus which is involved in the most recent outbreak (2019-nCoV) has four small chunks of sequence in its genetic code which are not found in other, similar coronaviruses like SARS. According to the authors, these pieces bear some resemblance to bits of sequence also found in HIV.
However, the authors then speculated that this might not be a coincidence and perhaps the bits of genetic code were put there intentionally. The conspiracy theory was addressed today by a scientist from the Wuhan Institute of Virology at the Chinese Academy of Sciences, who rubbished the claims.

The wider scientific community, upon seeing the paper, were also less than impressed with these conclusions and speculations and swiftly set about not only voicing their concerns, but analyzing the data to double-check the results.
Essentially, the scientists found that yes, there are some additions in the nCoV coronavirus originating in Wuhan that other coronaviruses don’t have, which are similar to pieces of sequence found in HIV. But, the kicker here is that these pieces of genetic code are also found in countless other viruses and there’s no reason to believe they specifically came from HIV, at all.
“The authors compared very short regions of proteins in the novel coronavirus and concluded that the small segments of proteins were similar to segments in HIV proteins. Comparing very short segments can often generate false positives and it is difficult to make these conclusions using small protein segments,” said Banerjee.
The paper was withdrawn from bioRxiv on Sunday afternoon with one of the authors stating: “ it was not our intention to feed into the conspiracy theories and no such claims are made here.” The author further declares that the researchers will revise the paper and re-analyze the data before submitting it again.
But despite the removal, the pre-print paper has stimulated a heap of discussion about HIV and coronavirus. Many people have asked on social media why, if coronavirus does not have pieces of HIV in it, HIV drugs are being used in some cases to treat the virus, with preliminary evidence that they, and other anti-viral drugs appear to be working in some cases.
“Some antiviral drugs can work against fundamental and generic steps involved in RNA virus replication. Anti-HIV drugs that inhibit viral RNA (genome) replication or the process of making viral protein from viral RNA may also work against other RNA viruses. This depends on the mode of action of the drugs,” explains Banerjee.
Presumably in response to the rather critical attention that this paper received, bioRxiv has added a banner ‘warning’ to every new preprint on the website:
“bioRxiv is receiving many new papers on coronavirus 2019-nCoV. A reminder: these are preliminary reports that have not been peer-reviewed. They should not be regarded as conclusive, guide clinical practice/health-related behavior, or be reported in news media as established information,” read the statement.
Publishing scientific articles as pre-prints without any peer review beforehand is controversial and complex, with one valid question being whether media outlets should cover pre-print work and risk potentially misinforming the public if the original results are not quite up to scratch, as happened with the recent HIV/coronavirus paper. Has this recent incident tarnished the reputation of preprints?
“No. In fact, I believe that this why pre-prints were established. The scientific community can provide feedback prior to formal peer-review. Pre-prints offer the authors an opportunity to seek feedback from a wider scientific community, more than the 2-3 peer-reviewers in a formal review setting” said Banerjee, stating that this paper certainly would not have passed official peer review.
“It is unfortunate that multiple articles on pre-print servers were victims of viral social media posts, especially studies that were not robust or scientifically sound,” said Banerjee. “But I am impressed how quickly other researchers debunked the studies and reanalyzed the data,” he added.
Note: the authors of the bioRxiv paper were contacted for comment but had not replied at the time of publishing this article.
https://www.forbes.com/sites/victoriaforster/2020/02/02/no-coronavirus-was-not-bioengineered-to-put-pieces-of-hiv-in-it/#3f2944a556cb

Haven has been quiet for the past 2 years — what does that mean for healthcare?

On Jan. 30, 2018, three dynamic companies partnered with the goal of revolutionizing healthcare delivery and lowering costs. Since then, we haven’t heard much from them about the venture.
Amazon, Berkshire Hathaway and JPMorgan Chase & Co., set out to improve employee satisfaction while decreasing the cost of care through a new venture, dubbed Haven. The three partners aimed to bring scale and expertise to their new venture, with a focus on technology solutions that would provide transparent healthcare at a “reasonable cost.”
“The ballooning costs of healthcare act as a hungry tapeworm on the American economy,” Berkshire Hathaway Chairman and CEO Warren Buffett said when the venture was launched. “Our group does not come to this problem with answers. But we also do not accept it as inevitable. Rather, we share the believe that putting our collective resources behind the country’s best talent can, in time, check the rise in health costs while currently enhancing patient satisfaction and outcomes.”
The announcement was made with much bravado but few details, which ignited speculation about how the three would work together. The emphasis on technology and transparency is intriguing, and given the 1.2 million lives covered by the companies, some speculated they would negotiate directly with healthcare providers to lower costs. Others wondered whether they would test new distribution models for prescription drugs through Amazon.
Amazon acquired PillPack shortly after the announcement, and last year also launched a telehealth service for employees. The company also continues to support data storage efforts through Amazon Web Services for hospitals and health systems, but during their most recent earnings call addressing revenue growth in 2019, CEO Jeff Bezos was silent about the company’s involvement in Haven.
In June 2018, Atul Gawande, MD, became the CEO of Haven and its headquarters officially followed Dr. Gawande to Boston. The partners also announced then that Haven would operate independently from the others as an entity “free from profit-making incentives and constraints.”
The last time Haven publicly issued a statement was last March, when its name was revealed, and website launched. At the time, the company said Dr. Gawande was meeting with employees across all three founding organizations to understand their healthcare experiences, and he was hiring experts from a variety of backgrounds. Since then, the company has seemed dormant to the public eye. What does that mean?
“Even such incredible minds and visionaries have been surprised at the true complexity and difficulties in bringing about change in healthcare,” said Randy Davis, CIO of CGH Medical Center in Sterling, Ill. “It’s 3-dimensional chess, and surprise, surprise, those in healthcare like it that way. They’ll nibble at their easy wins, but it won’t amount to huge dollars. CVS/Aetna is better positioned to really run at it than these folks. They have location going for them. The Panama Canal wasn’t a canal project; it was a railroad project to move dirt. When these ‘players’ figure out what the real project is, look out. I expect a major reference lab to be on their purchase list in the near future.”
It also takes time to really get a new venture off the ground, and mindfully execute change. Their silence could be a good sign, said Lee David Milligan, MD, senior vice president and CMIO of Asante Health System, based in Medford, Ore.
“In this case, their silence has earned my respect because it demonstrates that they are willing to accomplish the necessary due diligence before framing up their plan and executing. If they focus on their own employees and families, leverage technology only where it makes sense, eliminate the mind-boggling bureaucracy for patients and providers, and emphasize clinically proven health maintenance programs, they have a real shot at creating something special and sustainable.”
Theresa Hush, CEO of Roji Health Intelligence, isn’t surprised by the slow start either. However, she is intrigued by the venture’s focus on first dollar coverage and primary care access with an incentive for wellness and health maintenance.
“That is the opposite direction that market coverage and employers have been going,” she said. “It would not surprise me for Haven to begin partnerships with providers, or even to create its own health system as a logical next step. What that approach so far says is that they believe that healthcare has to go back to the basics before sophisticated disruptive tools to control costs and reform healthcare can be considered, and targeting their own large employee population creates the perfect experimentation platform for the venture.”
Haven’s 2018 debut also sparked a flurry of partnerships, acquisitions and acceleration of non-traditional entrants into the healthcare market. CIO of Memorial Healthcare System Jeffery Sturman expects more new entrants in the future, including retail companies, as healthcare remains ripe for disruption.
“Although Haven may be quiet for now, I wouldn’t underestimate the capabilities they and others can impart upon our healthcare industry,” he said. “I think this can create opportunities for us as we look to new forms of partnership and delivering care in different and more productive ways.”
https://www.beckershospitalreview.com/healthcare-information-technology/haven-has-been-quiet-for-the-past-2-years-what-does-that-mean-for-healthcare.html

New lobby to represent Fortune 500 firms paying prescription drug bills

Tired of being “the sucker at the table,” a group representing Fortune 500 companies has formed a lobby to push congressional drug-pricing policies that focus beyond Medicare, STAT reported.
EmployersRx is a joint project of the National Alliance of Healthcare Purchaser Coalitions, the Pacific Business Group on Health, the ERISA Industry Committee, and the Silicon Valley Employers Forum.
The group has described its goal as “to mobilize large employers to drive down prescription drug costs by advocating for public policies based on increased competition, transparency and value,” STAT said.
Roughly 61 percent of workers are covered by plans under which the employer pays for each employee’s healthcare. However, most of the policy ideas to lower drug costs have focused on changes to Medicare.
Michael Thompson, president of the National Alliance, told STAT that employers have “had enough of being the sucker at the table.”
“Someone needs to represent the sector that is actually paying most of the bill,” Bill Kramer, the executive director for national health policy at the Pacific Business Group on Health told STAT.
EmployersRx is hoping that its economic power of the business community can swing political dynamics in Washington, largely dominated by pharmaceutical industry players, such as the Pharmaceutical Research and Manufacturers of America.
https://www.beckershospitalreview.com/pharmacy/no-more-sucker-at-the-table-new-lobby-to-represent-fortune-500-firms-paying-prescription-drug-bills.html

Pandemic fears force Chinese biotech to postpone Hong Kong IPO meetings

At the same time the coronavirus outbreak originating from Wuhan is boosting shares prices of a raft of (mostly overseas) drugmakers, it appears to have also forced at least one domestic biotech to slow down its IPO plans in Hong Kong.
InnoCare Pharma — a Beijing-based company focused on cancer and autoimmune diseases with a lead drug now lined up at China’s regulator — has decided to postpone investor meetings intended to gauge demand for the HKEX listing, Bloomberg reported. According to anonymous insiders, InnoCare had planned to raise about $200 million.
Depending on whether and how quickly a pandemic ensues, this could mark the first of many IPO disruptions.
While the major ports between mainland China and Hong Kong remain open for the time being (a controversial arrangement in the supposedly semi-autonomous city), many of the institutional investors backing public debuts and the bookrunners they hire are in crisis mode.
Banks have started to ask employees coming back from mainland China to work from home for two weeks — roughly the incubation period for the 2019-nCoV — potentially making meetings with company execs difficult. Furthermore, travel restrictions have put face-to-face discussions on hold, with one European banker telling Bloomberg that he’s going to stay overseas for longer.
But a couple of pharma companies already listed, whether in Hong Kong or mainland China, offered some rare bright spots amid a catastrophic rout for China’s stock market once it reopened following the 10-day Lunar New Year holiday.
Ascletis, the first pre-revenue biotech to join the HKEX, enjoyed a 19% surge to HK$4.95 after it notified investors that it’s coordinating with medical institutions to launch clinical trials of its experimental combo of ASC09 and ritonavir. It continues an upward trend that began days ago when the biotech said it’s submitted an emergency use application to the National Medical Products Administration to use the therapy, originally designed for HIV, as a treatment for the 2019-nCoV infection.
Well-known players such as Shanghai Pharma, Harbin Pharmaceutical Group and Hansoh also scored single-digit gains, despite not ostensibly doing anything to combat the coronavirus.
It didn’t float all boats, though. Despite announcing that it’s set up a dedicated team to enable development of neutralizing antibodies to the virus, WuXi Biologics shares stayed somewhat flat at HKD$99.65.
In its filings from October InnoCare indicated that it would allocate much of the IPO proceeds to its lead drug, orelabrutinib, a BTK inhibitor that’s been accepted by the NMPA for review in relapsed or refractory chronic lymphoblastic leukemia and small lymphoblastic lymphoma. Two other clinical-stage assets target pan-FGFR and FGFR4, respectively, followed by six drug candidates execs want to bring into Phase I.

Pandemic fears force Chinese biotech to postpone Hong Kong IPO meetings — Bloomberg