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NIH awards nearly $250 million to seven firms making COVID tests

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nih awards nearly 250 million to seven firms making covid tests

The US government is investing a cumulative $248.7 million in seven biotech companies making next-generation coronavirus tests, the National Institutes of Health (NIH) announced Friday. 

Contracts are being awarded through the RADx program, announced in April, after the Trump administration and US health agencies were panned for shortages of and flawed tests. 

The US is now testing more than 800,000 people a day – but concerns over accuracy remain, including revelations that the widely distributed Abbott test, which was used by the White House may return false-negatives. 

As cases now surge in the South and West and new hotspots emerge, labs are buckling under high demand for diagnostics, and experts say the US needs o be running as many as 10 million tests a day to adequately keep up with the pandemic.

The NIH promised that tests authorized or in development from Mesa Biotech, Quidel, Ginkgo Bioworks, Talis Biomedical, Helix OpCo, Fluidigm and Mammoth Biosciences would help expand and speed testing in the US to deliver accurate test results inexpensively. 

Each of the seven tests has been through a ‘Shark Tank’ style development and review process and the investment will go toward scaling up the new tests. 

In a Friday press call, the NIH said that, in addition to the tests from Mesa and Quidel, the funding will go to scaling up the other new diagnostics so that they can run up to ‘millions of tests per week as early as September 2020,’ collectively said director Dr Francis Collins. 

By September, Dr Collins said the companies that are furthest along in their development processes should be able to run 50,000 tests a day each, reaching 100,000 tests a day by 2021. 

The NIH is investing nearly $250 million in seven new coronavirus tests, including the Sofia platform by Quidel, a point-of-care diagnostic

The NIH is investing nearly $250 million in seven new coronavirus tests, including the Sofia platform by Quidel, a point-of-care diagnostic

The NIH is investing nearly $250 million in seven new coronavirus tests, including the Sofia platform by Quidel, a point-of-care diagnostic 

Currently, the vast majority of coronavirus tests being used in the US are molecular tests that isolate and amplify bits of genetic material or enzymes specific to SARS-CoV-2. 

These types of tests are the ‘gold standard’ of diagnostics, but they’re not perfect and most have to be sent out to labs for analysis, creating longer wait-times for results or backlogs. 

NIH’s RADx (Rapid Acceleration of Diagnostics) program was launched in April to encourage and accelerate companies to innovate new tests for COVID-19. 

It’s one of several White House initiatives geared toward harnessing the private sector to address the coronavirus pandemic. 

More than 600 companies have applied to take part and 100 were selected to go through a one-week ‘shark tank’ process, 31 moved forward into a month-long second iteration, and seven have now been chosen to be scaled up. 

Three of the tests are point-of-care diagnostics, meaning they can be deliver results at the same clinic where a patient was swabbed, rather than being sent out to a lab for analysis. 

The other four are lab diagnostics, but use different technologies – called platforms in the diagnostics world – to test for coronavirus. 

THE NEW NIH-FUNDED TESTS THAT WILL DELIVER ON-SITE RESULTS

MESA BIOTECH

Like most diagnostics already in use, Mesa’s tests for traces of viral DNA in a sample swabbed from a patient’s nose or throat. 

But Mesa’s advantage is in it’s immediacy and portability. 

The entire test is contained in a hand-held device with single-use cartridges. It delivers results in 30 minutes. 

Mesa’s test was given emergency use authorization by the FDA in March, but will be able to scale up its tests with the NIH investment. 

Mesa's Accula test uses a disposable cartridge and promises on-site results in 30 minutes

Mesa's Accula test uses a disposable cartridge and promises on-site results in 30 minutes

Mesa’s Accula test uses a disposable cartridge and promises on-site results in 30 minutes

QUIDEL 

The San Diego-based company has also already received FDA approval for its point-of-care test. 

Rather than looking for bits of viral RNA, Quidel’s is an antigen test, which looks for SARS-CoV-2 via elements of the virus that reside on its surface. These are easier to find, chemically speaking. 

That make the test comparatively faster, but antigen tests have a higher probability of false-negatives. 

The NIH noted that tests that are slightly less accurate may be more useful in settings like business reopenings where the issue is less identifying a patient in immediate need of treatment, but more about detecting a possible outbreak.  

Already, Quidel has thousands of its Sofia Analyzers distributed across the US. Specifically, the Department of Health and Human Services (HHS) has specified that Quidel’s test is a good one for nursing homes, where cheap, regular testing and fast detection of outbreaks are matters of life and death. 

The test delivers results in just 15 minutes. 

TALIS BIOMEDICAL 

Similar to Mesa’s, Talis’s test is a cartridge-based test that identifies viral RNA on the spot, but using a different technology. 

The company says its test delivers results in under 30 minutes. 

US labs are overwhelmed as both coronavirus cases and demand for tests surges in places like Florida, where hundreds of cars lined up for drive-thru testing earlier this month

US labs are overwhelmed as both coronavirus cases and demand for tests surges in places like Florida, where hundreds of cars lined up for drive-thru testing earlier this month

US labs are overwhelmed as both coronavirus cases and demand for tests surges in places like Florida, where hundreds of cars lined up for drive-thru testing earlier this month 

NEW TECHNOLOGIES FOR LABS RUNNING THOUSANDS OF TESTS AT A TIME  

GINKGO BIOWORKS 

The Boston-based company is making a lab based test, but one that uses automation to speed of the process. 

Ginkgo’s machine can run thousands of samples at a time, thanks to the way that it sequences genes from the virus. 

It can turn around results within one to two days. It anticipates being able to run 50,000 tests a day by September, ramping up to 100,000 a day by year-end.  

HELIX OPCO

Similar to GinkGo, Helix can process thousands of samples at a time on its machines.

Its test will specifically be sent to public health departments, large companies and health care systems that are in dire need of high-capacity testing. 

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31425146 8580689 image a 13 1596222200532

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31425142 8580689 image a 14 1596222205337

FLUIDIGM 

Fluidigm’s test uses ‘microfluid’ technology that makes the analysis process simpler and faster than that of a standard PCR (polymerase chain reaction) test. 

It’s not yet clear how many tests a day, exactly, Fluidigm’s technology will be capable of running, but the NIH estimates it could do tens to hundreds of thousands daily by the fall. 

MAMMOTH BIOSCIENCES 

Although it too makes a lab test, Mammoth’s is unique among the group. 

The relatively young company was the first and remains the only test to get FDA approval for using CRISPR – the biochemical tool that allows scientists to edit genes – to detect coronavirus. 

The CRISPR tool was designed to ‘find and replace’ faulty genes, but Mammoth has retooled it find coronavirus genes in samples from patients. 

CRISPR does this with remarkable speed and accuracy, outpacing the CDC’s test. 

Mammoth promises that, once its production is ramped up, its technology will lead to a ‘multi-fold’ increase in the amount of testing that can be done at labs.    

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Doctors test out new treatment in bid to boost your blood flow

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doctors test out new treatment in bid to boost your blood flow

Standing on a pulsating plate for half an hour is a treatment being tested to help with reduced blood flow in the legs, easing the pain of a common circulatory condition.

One in five over-60s has peripheral arterial disease (PAD), a build-up of fatty deposits in the walls of the arteries in the legs, causing restricted blood flow and preventing muscles from working properly.

Muscles require a regular supply of oxygen and nutrients, which is provided by blood that flows through a network of arteries. 

While some patients with PAD have no symptoms, in others, blood flow is so restricted that even walking causes crippling pain, a problem known as intermittent claudication. This pain usually disappears after a few minutes’ rest.

The vibrating plate treatment, called Revitive, is being trialled in the NHS and is hoped to improve blood flow in the legs and ease the pain of peripheral arterial disease. (Stock image)

The vibrating plate treatment, called Revitive, is being trialled in the NHS and is hoped to improve blood flow in the legs and ease the pain of peripheral arterial disease. (Stock image)

The vibrating plate treatment, called Revitive, is being trialled in the NHS and is hoped to improve blood flow in the legs and ease the pain of peripheral arterial disease. (Stock image)

People with the condition — a form of cardiovascular disease — often also have furring of other arteries in the body, putting them at risk of heart attack and stroke, and damage to vital organs. 

Treatment of PAD usually involves surgery, taking a segment of healthy vein from elsewhere in the body, and using it to bypass the blockages and restore an adequate blood supply in the legs. Some 23,000 such procedures are performed each year in the UK.

The two-hour operation is highly effective in many cases. After surgery, exercise is recommended as this has been shown to have beneficial effects on the workings of the blood vessels in the legs. 

However, many patients fail to follow these rehabilitation programmes, says Dr Punit Ramrakha, a consultant cardiologist at Hammersmith Hospital in London, and as a result, the graft can fail.

If this happens, tissue becomes starved of oxygen and nutrients and can get infected and die, leading to the leg being amputated, typically below the knee.

The vibrating plate — called Revitive and being trialled in the NHS — offers a new way to help keep these grafts working.

During a 30-minute session, patients will receive  electrical pulses to the soles of the feet which activate nerves in the legs and helps boost blood flow. (Stock image)

During a 30-minute session, patients will receive  electrical pulses to the soles of the feet which activate nerves in the legs and helps boost blood flow. (Stock image)

During a 30-minute session, patients will receive  electrical pulses to the soles of the feet which activate nerves in the legs and helps boost blood flow. (Stock image)

During a 30-minute session, it delivers electrical pulses to the soles of the feet which activate nerves in the legs, causing muscles to contract and relax and boost blood flow.

The device offers varying degrees of stimulation in different settings. Improvements in blood flow suggest a promising role for the device in keeping these grafts open and helping them last longer, say doctors from Charing Cross Hospital in London, who are carrying out a trial with 34 patients. 

These patients will have a one-off session with the device after surgery to see whether it improves blood flow.

A new study, published in the journal Wound Management & Prevention, found that blood flow to the foot increased by more than 40 per cent when healthy volunteers used the device for ten minutes.

Dr Ramrakha says: ‘Neuromuscular electrical stimulation of leg muscles . . . may effectively substitute, promote or complement physical training. This trial will show whether this technology will assist the patients on the road to recovery.’

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DR MARTIN SCURR answers all your health questions 

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dr martin scurr answers all your health questions

QUESTION: I get post-nasal drip. I was told it might be caused by acid reflux, but I don’t have the classic symptoms. What else could be causing it?

Stephen Pearson, by email.

ANSWER: Post-nasal drip (clinically, known as chronic rhinitis) is where mucus accumulates in the nose and drips down the throat, causing a sensation of excess fluid. Other symptoms include nasal discharge, a blocked or stuffy nose, sneezing, coughing and, in some instances, loss of smell.

While acid reflux (where stomach acid rises up the oesophagus) can cause this, I think there is another, much more common, explanation here: in 90 per cent of cases, the cause is allergy. 

Post-nasal drip is where mucus accumulates in the nose and drips down the throat, causing a sensation of excess fluid. (Stock image)

Post-nasal drip is where mucus accumulates in the nose and drips down the throat, causing a sensation of excess fluid. (Stock image)

Post-nasal drip is where mucus accumulates in the nose and drips down the throat, causing a sensation of excess fluid. (Stock image)

Symptoms may occur all year round or can be seasonal, depending on the trigger. Most GPs prescribe allergy suppressants, such as antihistamine tablets. If these end the symptoms, it confirms the cause is an allergy.

In severe cases, patients should be referred to an ear, nose and throat (ENT) specialist or allergy clinic for skin-prick tests (where a small amount of the suspected allergen is scratched on to the skin).

For most patients, regular treatment is the best way to keep symptoms at bay. This starts with corticosteroid nose drops, usually betamethasone, for a few months or until symptoms are abolished (it works by reducing inflammation and swelling in the nose). This is then followed by a nasal spray as maintenance therapy.

A more recent innovation has been a mix of steroid and antihistamine, such as Dymista, given via nasal spray. 

Dr Martin Scurr (pictured) examines post-nasal drip and its treatments

Dr Martin Scurr (pictured) examines post-nasal drip and its treatments

Dr Martin Scurr (pictured) examines post-nasal drip and its treatments

This can be highly effective and avoids the potential side-effects of steroids given via nose drops (which include excessive nasal dryness and nosebleeds with long-term use).

You say in your longer letter that you get some relief using Beconase, a mild corticosteroid nasal spray, but it makes you drowsy — this can be a side-effect of even the most modern antihistamines. 

Given your partial response to Beconase, it might be worth trying the more potent steroid fluticasone, which your doctor may prescribe, and then moving on to the Dymista spray.

If fluticasone is not helpful, then I suggest you seek referral to an ENT specialist for further consultation.

QUESTION: My grandson, who is eight, suffers tummy pains after eating. His GP has ruled out coeliac disease and advised a dairy-free diet. My wife and I are worried and want a referral to a paediatrician.

David Swift, Watford, Herts.

ANSWER: A history of recurrent pain for longer than two months with no other alarming symptoms — such as weight loss, vomiting, unexplained fever or bloody diarrhoea — is called chronic abdominal pain.

Acute pain with any of the symptoms I describe is linked to potentially life-threatening problems, such as appendicitis, intussusception — when part of the intestine ‘telescopes’ inside another part — or volvulus (when the intestine twists on itself). But in your letter you say that, in between episodes, your grandson is happy and sporty.

A history of recurrent pain for longer than two months with no other alarming symptoms is called chronic abdominal pain. (Stock image)

A history of recurrent pain for longer than two months with no other alarming symptoms is called chronic abdominal pain. (Stock image)

A history of recurrent pain for longer than two months with no other alarming symptoms is called chronic abdominal pain. (Stock image)

It would seem the GP views him as having a form of ‘functional’ abdominal pain — this is where the pain is real but there’s no definitive test for it, and includes functional dyspepsia (abdominal discomfort or a sense of over-fullness), irritable bowel syndrome and abdominal migraine (intense pain).

In general, it’s better that this kind of pain is treated in primary care as there’s evidence that referral for specialist investigations may carry a message to patient and family that there’s an underlying disorder yet to be discovered, causing them more anxiety.

In my view…we must improve the care we give older patients 

When it comes to the care of older people, it’s clear that the NHS is stumbling badly. I see or hear evidence of this daily — most recently I was told about a woman in her 70s found dead after a neighbour noticed her curtains remained closed for days.

There was no record of her having seen a doctor for years, so a post-mortem examination was mandatory. This revealed she’d likely had a heart attack.

She died alone without support or care. If she had experienced symptoms and sought medical attention, her death probably could have been prevented. But she was on the autistic spectrum and in the past had been confused and frightened by the complexity of her GP’s recorded phone system, so she had given up trying to call.

You might wonder why friends didn’t help but, if any had called on her behalf, it’s likely they would have been told they didn’t have the authority to do so, as indeed I was when calling a practice on behalf of my 93-year-old neighbour after recognising she had heart failure. 

I was told my only option was to register online as her carer, which I tried to do, only to be informed that, due to Covid, the website was not operational. I’ve written to the GP and practice nurse but had no reply — a patient in heart failure all but abandoned.

Finally, my mother, 91, frail and diabetic, was told by text to go for a blood test at the local hospital, only to find out later that it was closed for blood tests and that she needed to go to a hospital in central London, more than ten miles away.

This is the status of primary healthcare in the NHS for a big part of our community.

 

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Nurse invited grief-stricken 81-year-old grandmother to her house for Christmas Day 

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nurse invited grief stricken 81 year old grandmother to her house for christmas day

After Angela Coverdale-Robinson missed the last train back to her home in Cambridge on Christmas Eve, she faced a bleak few days alone, hundreds of miles from her family.

The 81-year-old grandmother resigned herself to spending a solitary Christmas in a hastily booked bed and breakfast in Newcastle upon Tyne, mourning her brother-in-law Alfie, who had died that evening at South Tyneside District Hospital.

But when ward sister Nicola Peat learnt of Angela’s plight, she was having none of it.

The 44-year-old’s nursing team had told her about Angela’s predicament, and she immediately invited the grief-stricken pensioner to spend Christmas with her and her family.

Nicola Peat (pictured), 44, from South Tyneside, invited a grief-stricken grandmother to her home on Christmas Day

Nicola Peat (pictured), 44, from South Tyneside, invited a grief-stricken grandmother to her home on Christmas Day

Nicola Peat (pictured), 44, from South Tyneside, invited a grief-stricken grandmother to her home on Christmas Day 

‘I’m coming to get you in the morning and I would love for you to be with us,’ Nicola told Angela over the phone.

So a grateful Angela found herself the impromptu guest of honour on Christmas Day at Nicola’s home in East Boldon, South Tyneside, where she was made welcome by Nicola’s husband David, 48, a teacher, and children Jacob, 16, and Isabella, 12.

‘It could have been so bleak for me, but the kindness shown by Nicola blanketed that,’ says Angela, a former paediatric nurse. ‘Alongside her compassionate nursing and care for Alfie, Nicola showed the true spirit of Christmas.’

Angela first met Nicola two weeks before Christmas in 2019. She had travelled to Newcastle upon Tyne to see Alfie, 82, who was the brother of her late husband, John. Angela sat at Alfie’s bedside every day, until late on the night before Christmas.

‘We are a close family and, even though it was Christmas Eve, I wanted to be with Alfie in his final hours,’ says Angela.

But that evening, at the urging of a doctor, Angela had reluctantly left Alfie to travel home to her children and grandchildren 240 miles away so she could spend Christmas with them.

Upset and distracted — ‘I wasn’t thinking straight’ — she missed the last train home, so decided to return to the hospital to be with Alfie, without knowing how to get there in the wintry dark.

‘I was crying and tired,’ says the grandmother of seven. And then, in a surreal moment, she spotted a man dressed as Father Christmas, much the worse for wear, who pointed her to the right bus stop for the hospital.

‘I was so pleased I did go back, as Alfie died just before midnight,’ she says. ‘ ‘He waited for you to come back,’ whispered a nurse as she comforted me.’

Angela Coverdale-Robinson, 81, missed the last train back to her home in Cambridge on Christmas Eve

Angela Coverdale-Robinson, 81, missed the last train back to her home in Cambridge on Christmas Eve

Angela Coverdale-Robinson, 81, missed the last train back to her home in Cambridge on Christmas Eve

Retired health visitor Nora Alnes (right with Nicole), 100, from East Boldon, believes Nicola has done her absolute best for those in her care

Retired health visitor Nora Alnes (right with Nicole), 100, from East Boldon, believes Nicola has done her absolute best for those in her care

Retired health visitor Nora Alnes (right with Nicole), 100, from East Boldon, believes Nicola has done her absolute best for those in her care

After Alfie’s death, the nurses made Angela a hot drink and a sandwich while her son, Daniel, a 53-year-old businessman who lives in Saffron Walden, Essex, phoned around to find her a B&B to stay in until Boxing Day. But then came Nicola’s invitation.

‘I couldn’t fault the nursing Alfie received from Nicola and her team, and not a day goes by when I don’t think of her kindness, patience and tolerance,’ says Angela. ‘Compassion shines from her and she is a role model for any nurse.’

Retired health visitor Nora Alnes, 100, from East Boldon, couldn’t agree more.

Nora, who started nursing during World War II, met Nicola while in hospital recently with hip problems. ‘Nicola was so kind to me, and when she knew I loved perfume, she gave me a bottle of her favourite Jo Malone scent, which made my day,’ she says.

‘On my 100th birthday in December, Nicola called in to see me after work with flowers and chocolates. She also nursed my sister Margery [who had been a theatre nurse] before her death aged 94 in February. Nicola is very special and brilliant at her job.’

These are not unique examples of her kindness and willingness to go above and beyond the call of duty. 

Nicola, who has been a manager on a 42-bed surgical ward for the past 12 years, is known in normal nursing times to do a patient’s washing if they have no family who can do it.

She regularly makes quiches and cakes for patients and staff, and even brings in meals for the younger staff when their parents are away on holiday.

‘Her Thai red curry is fab,’ says staff nurse Abby Carr, 23. ‘She is so inspirational as a role model. We learn so much from her.’

Nora, who started nursing during World War II, met Nicola while in hospital recently with hip problems

Nora, who started nursing during World War II, met Nicola while in hospital recently with hip problems

Nora, who started nursing during World War II, met Nicola while in hospital recently with hip problems

Nicola leads by example. One day recently, after a long shift and having changed out of her full PPE (during the pandemic the ward has been transformed into a Covid intensive care ward), she was heading home when she passed a bay and noticed a patient who was extremely distressed because he could see a fellow patient deteriorating.

She immediately returned to the changing rooms, put on the hot and uncomfortable PPE again and went to comfort him, sitting by his bed for more than an hour.

Nicola, who became a nurse 22 years ago, following in the footsteps of her mother and grandmother, is strikingly modest about her work. ‘Helping patients like this is just part of my job,’ she says.

Angela, who has nominated Nicola for a Daily Mail Health Hero Award, says: ‘I was upset at the prospect of spending Christmas Day apart from my own family, but it was fabulous being with Nicola and her family, who enfolded me in their love at a time of grief. It was a Christmas I will never forget.’

It is people like Nicola who exemplify what the Daily Mail Health Hero Awards are all about — NHS staff quietly getting on with their work but going that extra mile.

We’d like you to nominate your own Health Hero. It could be a nurse or ward sister like Nicola, a porter, a consultant — anyone who you feel deserves recognition.

Seven finalists will be treated to an all-expenses-paid trip to London for an awards ceremony, and the winner will receive a £5,000 holiday. This year, we have introduced two extra awards. 

The Daily Mail Health Hero Awards runs in partnership with eBay and NHS Charities Together

The Daily Mail Health Hero Awards runs in partnership with eBay and NHS Charities Together

The Daily Mail Health Hero Awards runs in partnership with eBay and NHS Charities Together

The first is the Mental Health Hero Award, to highlight the unsung work of those who specialise in this often very difficult field. The other is an eBay Health Hero Award, to recognise volunteers who support health professionals working in the NHS.

As Rob Hattrell, the vice president of eBay UK, one of our partners for this year’s awards, explains, this category ‘is dedicated to an incredible individual who has kept us going and smiling when the country ground to a halt and needed it most’.

As a mark of Angela’s gratitude to Nicola, she gave a handwritten copy of a poem, A Nurse’s Prayer, to the ward, where it now has pride of place.

The poem, which was given to Angela in 1958, when she was working at the Royal Papworth Hospital in Cambridgeshire, includes the lines: ‘When the day is done and evening stars, shine through the dark across the sunset bars, when weary quite, I turn to seek my rest, Lord, may I truly know I’ve done my best.’

As former nurses themselves, both Angela and Nora believe Nicola has done her absolute best for those in her care.

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