FDA OKs emergency use of Quest COVID-19 test for pooled sample use

Quest Diagnostics (NYSE:DGX) has received emergency use authorization (EUA) from the FDA to use specimen pooling with its molecular diagnostic test for COVID-19.

In pooling, specimens must still be collected into individual vials, but then are combined into small batches or pools by the laboratory. The technique is an efficient way to evaluate patients in regions or populations with low rates of disease.

The company’s SARS-CoV-2 RNA test may be used with pooled upper respiratory specimens (nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swabs).

The company expects to deploy the technique at its laboratories in Chantilly, VA and Marlborough, Mass., by the end of next week with additional laboratories to follow.

The FDA also granted three EUAs for use of self-collection molecular diagnostic kit on the Hologic and Roche platforms, expanding use with healthcare provider supervision via telemedicine.

https://seekingalpha.com/news/3592458-fda-oks-emergency-use-of-quest-covidminus-19-test-for-pooled-sample-use

BOJ policymakers debated risk of return to deflation at June meeting

A few Bank of Japan policymakers warned there was a risk the country might slip back into deflation if the coronavirus pandemic led to more bankruptcies, minutes of the central bank’s June rate review showed on Monday.

With the impact of COVID-19 likely to last for a prolonged period, more companies could face the risk of insolvency even if they received immediate liquidity support, some on the BOJ’s nine-member board were quoted as saying.

At the June 15-16 meeting, the BOJ kept monetary policy steady and maintained its view the economy will gradually recover as the pandemic subsides.

https://www.reuters.com/article/japan-economy-boj/boj-policymakers-debated-risk-of-return-to-deflation-at-june-meeting-minutes-idUST9N2DM00R

Coronavirus Hospitalizations In U.S. Decline For First Time Since June

Coronavirus hospitalizations in the U.S. have fallen for the first time in the month of July, according to data from The COVID Tracking Project, as hard-hit states like Arizona and Texas are beginning to show signs of improvement when it comes to hospitalizations, even as the nation’s coronavirus epicenter, Florida, has shown little sign of a turnaround.

Coronavirus hospitalizations in the U.S. dropped from 57,705 on Friday to 57,562 on Saturday, according to The COVID Tracking Project—the first national decline since June 28.

Coronavirus hospitalizations in Arizona are now at their lowest point in over two weeks, and Texas has reported a decline in hospitalizations three out of the past five days.

Both of the states also have had a gradual drop in the testing positivity rate, seen as a key indicator of whether coronavirus spread is increasing.

But Texas did report a new record high in coronavirus deaths on Friday, with Arizona following on Saturday, though deaths tend to lag behind earlier spikes in infections and then hospitalizations.

There is still little indication that Florida’s crisis has peaked.

Hospitalizations have continued to rise in the state, and there were 48 hospitals that reported ICUs were at capacity Sunday afternoon.

Coronavirus cases are continuing to spike across the U.S., as they have been for well over a month, and the 5-day average for new confirmed cases is now over 70,000 per day, according to Johns Hopkins University—by far the highest any country has reported throughout the pandemic. That surge has been led by Florida, which has reported new daily case counts higher than even the top days that New York reported during the first major American coronavirus surge in March and April.

BIG NUMBER

40 — That’s how many states are dealing with an increasing rate of new coronavirus cases, according to data from The New York Times. Those increases are usually followed by a rise in hospitalizations and eventually deaths, meaning it’s possible the current decline might quickly reverse.

https://www.forbes.com/sites/nicholasreimann/2020/07/19/coronavirus-hospitalizations-in-us-decline-for-first-time-since-june/#2c6cac826e1a

Prostate cancer: How to decide when to treat

You have been diagnosed with prostate cancer and your doctor gives you the option of not being treated, but of remaining under observation: is there any objective way you can decide to be treated or not treated? What should you do? Now using first results from analysis of the world’s biggest Active Surveillance prostate cancer database, the GAP3 consortium* has begun to identify which patients are at risk of the disease developing and which patients can continue to safely delay treatment. This work is presented at the virtual European Association of Urology congress.

As lead researcher, Dr Mieke Van Hemelrijck (King’s College London) says: “Current methods of deciding whether or not to recommend treatment are not reliable. Our analysis shows that we should be able to produce a single global methodology, which will give accurate estimates on how aggressive these cancers are. These will feed directly into the treatment decision, and give men the reassurance they need to decide on treatment”.

Prostate cancer is one of the leading causes of death in men, but many men who discover they have prostate cancer are not in any immediate danger: they have Low Risk Prostate Cancer. Over the past 10 years, an increasing number of these men have been given the option of going on active surveillance, rather than being immediately treated. Active surveillance means that men continue to be monitored and tested (via PSA levels, biopsy, and other tests), with treatment only starting when the cancer shows signs of developing. The number of men on active surveillance varies from country to country, with up to 80% of men delaying treatment in some countries. However, there are no generally accepted ways of understanding who is at risk, and as many as 38% of men who start active surveillance drop out within 5 years.

Van Hemelrijck said: “Prostate cancer treatment can have significant side-effects such as erectile dysfunction and incontinence, so often avoiding intrusive surgery or radiotherapy can benefit the patient. Nevertheless, being told you have cancer puts great psychological pressure on men to agree to treatment, so understanding just how aggressive the cancer is before deciding on treatment is essential. At the moment we just don’t have that reassurance”.

Although active surveillance is considered a real step forward in management of low risk prostate cancer, there is surprisingly little agreement on which men will benefit. Doctors consider a range of factors, such as age, PSA score, biopsy details, technical details of the cancer, and so on. But the decision on whether or not to start treatment is still often subjective. Erasmus MC , department of Urology was tasked by Movember to coordinate the development of a global database on Active Surveillance (the GAP3 consortium). Dr Van Hemelrijck worked with a team of researchers from the GAP3 Consortium to develop the world’s most accurate active surveillance nomogram.

A nomogram is a treatment calculator, similar to an App: you feed in the details and it gives you advice on whether or not to treat. Local nomograms exist, but a global version is needed to be generally applicable. Working with data from the 14,380 patients on the Movember database (the world’s largest), they were able to input data such as age, size and condition of the tumour, PSA, biopsy details, time on active surveillance, genetic factors, etc.

“Not surprisingly, we have found that even accounting for these factors there was still differences in outcomes between participating centres. But this work has shown that it will be possible to produce a nomogram which can guide treatment. Just as importantly, the work shows which additional factors need to be included in the nomogram in future to enable us to eliminate this variation and produce accurate estimates of tumour aggressiveness”.

Commenting, EAU Adjunct Secretary General Professor Hendrik Van Poppel (University of Leuven, Belgium ) said:

“This work shows that it should be possible to develop a global nomogram – in other words, a system which allows us to predict whether active surveillance will be suitable for individual low and intermediate risk prostate cancer patients. This would be an important step forward in terms of the reassurance we can offer patients, and in choosing treatment pathways. The urology community would welcome this, and will be happy to cooperate in taking this project forward”.

This is an independent comment; Professor Van Poppel was not involved in this work.

###

For more information on the GAP3 projects see https://gap3.movemberprojects.com/

The 35th European Association of Urology conference takes place online from 17-19 July, 2020. This replaces the physical conference which was scheduled to take place in Amsterdam. The EAU conference is the largest and most important urology congress in Europe, with up to 14,000 attendees. Conference website

https://eaucongress.uroweb.org/

Type of research: Not peer reviewed/observational research/ people

https://www.eurekalert.org/pub_releases/2020-07/eaou-pch071620.php

Oxford U ‘on track’, coronavirus vaccine likely to be available by September

Oxford University’s coronavirus vaccine trial team is ‘absolutely on track’ and the vaccine could be available as early as September, David Carpenter, Chairman of the Berkshire Research Ethics Committee, which approved the Oxford trial has said. This comes as a big breakthrough in the fight against coronavirus. ‘The Lancet’ medical journal has confirmed that it would be publishing early-stage human trial data from the Oxford team on Monday.

“Nobody can put final dates… things might go wrong but the reality is that by working with a big pharma company, that vaccine could be fairly widely available around September and that is the sort of target they are working on,” David Carpenter said.

The vaccine development, by the university’s Jenner Institute, is being supported by the UK government and AstraZeneca, which will support the production phase. Oxford’s potential Coronavirus Vaccine has been licensed to AstraZeneca.

Researchers at the University of Oxford believe they may have a breakthrough in their search for a COVID-19 vaccine after the team discovered that the jab could provide “double protection” against the deadly coronavirus following early-stage human trials, according to media reports in the UK.Blood samples taken from a group of UK volunteers given a dose of the vaccine showed that it stimulated the body to produce both antibodies and “killer T-cells”, a senior source from the trial was quoted by ‘The Daily Telegraph’ as saying.

The discovery is promising because separate studies have suggested that antibodies may fade away within months while T-cells can stay in circulation for years.

However, the source cautioned that the results, while “extremely promising”, did not yet prove that the Oxford vaccine provides long-lasting immunity against the deadly virus.

“I can tell you that we now know the Oxford vaccine covers both bases – it produces both a T cell and an antibody response. It’s the combination of these two that will hopefully keep people safe. So far, so good. It’s an important moment. But we still have a long way to go,” the source said.

Another source close to the team described the presence of both antibodies and T-cells as a “double defence” against COVID-19.

Phase 3 trial of vaccine begins

The pharmaceutical company said last month that phase one trials were due to finish and a phase three trial had begun which will see the vaccine given to thousands of people so it can be tested for efficacy and safety.

“The COVID-19 vaccine trial team have been working hard on assessing the safety and immunogenicity of ChAdOx1 nCoV-19, and preparing to assess vaccine efficacy,” Sarah Gilbert, professor of vaccinology at the university’s Jenner Institute who is leading the research, had said back in May.

What Oxford University’s COVID-19 vaccine is based on

The vaccine, named ChAdOx1 nCoV-19, is based on a weakened version of the common cold that causes infections in chimpanzees. It also contains the genetic material of the spike protein of SARS-CoV-2 – the strain of coronavirus that causes the COVID-19 illness.

The Oxford University vaccine is one of more than 100 in development as the novel coronavirus continues to spread – infecting more than 13 million people and killing at least 582,000 worldwide.

https://www.indiatvnews.com/news/good-news/coronavirus-vaccine-by-september-oxford-university-trial-on-track-astrazeneca-634907

Biotech week ahead, July 20

Biotech stocks advanced in the week ended July 17 thanks to positive broader market sentiment, encouraging news flow on the COVID-19 front and fairly positive results reported by pharma giant Johnson & Johnson JNJ 0.09%.

Equillium Inc EQ 6.16% was among the biggest gainers of the week after a drug that it licensed from Biocon was granted emergency use authorization in India for treating cytokine release syndrome in COVID-19 patients with moderate to severe acute respiratory distress syndrome.

Moderna Inc MRNA 15.94% advanced in all five sessions of the week, with detailed interim Phase 1 data publication, positive sell-side commentary and news of inclusion in the Nasdaq 100 Index serving as catalysts.

The following are key catalysts in the unfolding week.

Conferences

Galactosemia Foundation 2020 Virtual Conference, July 17-19

PDUFA Dates

The FDA is set to rule on Jazz Pharmaceuticals PLC’s JAZZ 0.48% NDA for JZP-258, which is being evaluated as a treatment option for cataplexy —excessive daytime sleepiness — in patients 7 and older with narcolepsy.

Earnings

Biogen Inc BIIB 0.84% (Wednesday, before the market open)

Quest Diagnostics Inc DGX 1.07% (Thursday, before the market open)

West Pharmaceutical Services Inc. WST 2.77% (Thursday, before the market open)

Edwards Lifesciences Corp EW 3.08% (Thursday, after the close)

LeMaitre Vascular Inc LMAT 1.53% (Thursday, after the close)

IPOs

ACell, a regenerative medicines company that develops products designed to facilitate the body’s ability to repair and remodel tissue, is planning a 5-million-share IPO at an estimated price range of $14-$16. The company has applied for listing its shares on the Nasdaq under the ticker symbol “ACLL.”

IPO Quiet Period Expirations

Polypid Ltd PYPD 0.88%

Akouos Inc AKUS 1.93%

Fusion Pharmaceuticals Inc FUSN 0.13%

ADiTx Therapeutics Inc ADTX 1.72%

https://www.benzinga.com/general/biotech/20/07/16674331/the-week-ahead-in-biotech-jazz-awaits-fda-nod-for-sleep-disorder-drug-earnings-trickle-in-acell-i

Nicklaus says he was ill with COVID-19 earlier this year

Jack Nicklaus, the 18-time golf major winner, said on Sunday that he was ill with COVID-19 earlier this year and his wife Barbara had also tested positive for the coronavirus.

At 80 years old, Nicklaus is in the higher risk category for being seriously ill with the disease, which has killed more than 140,000 people in the United States. He said he counted himself lucky to have come through with a relatively mild case.

Speaking during a weather delay in final round play of the Memorial Tournament that he hosts, Nicklaus said that while he had symptoms of the illness, his wife was asymptomatic. The couple self-isolated at their home in south Florida from March 13 to April 20.

“Barbara was asymptomatic, I had a sore throat and a cough, it didn’t last very long,” said Nicklaus in an interview with CBS. “We were very, very fortunate, we were lucky.

“Barbara and I are both of the age, both of us 80-years-old, that it’s an at risk age,” he said. “Our hearts do go out to the people who did lose their lives and their families, we were just a couple of the lucky ones.”

Nicklaus said that he had tested positive four times and his wife Barbara three. Both have since tested positive for the coronavirus antibody.

While the Centers for Disease Control and Prevention have advised people not to shake hands with others during the pandemic, Nicklaus said last week that he hoped to continue the tradition of shaking the winner’s hand on the 18th green.

He said on Sunday that he was still willing to shake hands but would leave it up to the winner to decide.

“So we’ll have to see what he wants to do,” said Nicklaus.

https://www.reuters.com/article/us-health-coronavirus-golf-nicklaus/nicklaus-says-he-was-ill-with-covid-19-earlier-this-year-idUSKCN24K0S5