UniQure's gene therapy for hemophilia B meets first goal in key study

 The first results from a late-stage study of a gene therapy for hemophilia B show the treatment can readily replace the blood-clotting protein missing in people with the inherited disease, confirming tantalizing findings from years of earlier research.

For most of the 54 patients enrolled in the trial, called HOPE-B and run by the biotech UniQure, that was enough to eliminate bleeding events over the six months following infusion with the company's gene therapy, data released Thursday show. All but two participants in the trial discontinued the routine preventive treatment people with severe hemophilia must take several times per week.

The results are an encouraging step for UniQure and its would-be medicine. Yet, they leave some questions, too.

Fifteen patients still experienced bleeds following treatment, some more than once. While UniQure didn't break out specific data, the 21 total events observed across those 15 participants included spontaneous bleeds, as well as bleeds related to surgical procedures or injury.

In some cases, the bleed needed to be treated by standard clotting replacement treatment, an intervention researchers hope gene therapy can do away with for hemophilia patients.

Yet the fact that some patients experienced bleeds after treatment isn't necessarily cause for concern, according to Courtney Lawrence, a hematologist at Johns Hopkins Medicine.

Gene therapy trials like UniQure's are enrolling adult patients with moderate to severe hemophilia, she noted, and many of those individuals are likely to have joint disease due to decades of major bleeds.

"For nearly three quarters of high-risk patients to experience no bleeds in a six month period would be considered by most clinical providers to be a truly excellent clinical response," Lawrence added. She was not involved with UniQure's study.

Further details won't be available until December, when data from HOPE-B will be presented at a virtual meeting of the American Society of Hematology. The data released Thursday are from a "late-breaking" trial abstract made available ahead of the conference, which UniQure confirmed in a release of its own.

UniQure's therapy, called etranacogene dezaparvovec or AMT-061, is the most advanced gene therapy for hemophilia B and the first to deliver results from a Phase 3 trial. Another, from Pfizer, is also in late-stage testing, with data expected next year. Others from Freeline Therapeutics and Takeda are earlier in clinical development.

Based in Lexington, Massachusetts, and Amsterdam, UniQure has been working on hemophilia B gene therapy for nearly a decade, extending the work of its precursor company Amsterdam Molecular Therapeutics.

Etranacogene dezaparvovec is a second-generation treatment, designed to be more potent than an earlier gene therapy known as AMT-060.

Both work by delivering, via a special type of virus, a functional copy of the gene that's damaged in patients with hemophilia B. The newer therapy uses a naturally occurring gene variant discovered in Padua, Italy, that's been shown to spur greater production of blood-clotting protein.

Development of the treatment has put UniQure at the forefront of efforts to use genetic medicine to definitely treat inherited conditions like hemophilia, which was one the first diseases to be linked to mutations in a single gene.

Earlier this year, CSL Behring paid UniQure $450 million — and promised another $1.6 billion in conditional payments — to secure global rights to UniQure's treatment.

HOPE-B is the key test of the therapy's potential. UniQure expects results from the trial would support an application to the Food and Drug Administration for approval in severe and moderately severe hemophilia B next year.

Thursday's data are from the first half of the study, which measured levels of a key clotting protein, known as Factor IX, in the blood. Six months post-treatment, average Factor IX activity increased from less than 2% at baseline to 37%, high enough to be classified as mild hemophilia and close to what's considered a normal range.

"I think all of us feel pretty comfortable that, the closer we get to the normal range, this is probably going to be a meaningful transformation for patients, such that they really don't have to think about their hemophilia any more," said Steven Pipe, a hemophilia specialist and lead author on the HOPE-B study results, in an interview.

Lawrence, from Johns Hopkins, put it more practically.

"I would be much less worried about my patient with a factor level of 35% who wants to go hiking in the mountains two hours from the nearest hospital than I would be [about] my patient with a factor level of 3%, unless they were armed with factor concentrate at the ready," she wrote.

Originally, measuring Factor IX activity at 26 weeks was the sole primary goal of the trial. After conversations with the Food and Drug Administration, however, UniQure decided to make Factor IX activity at one year, as well as the annualized bleeding rate, "co-primary endpoints."

The change, which does not appear to have been previously disclosed, could suggest the regulator may be putting more emphasis on measuring how long Factor IX levels stay elevated as well as how well that translates to elimination of bleeds.

A spokesperson for UniQure said the company would further discuss the endpoint change with the FDA during a pre-application meeting.

The FDA's views on hemophilia gene therapy are newly a point of discussion, after the agency in August unexpectedly rejected a gene therapy for hemophilia A developed by BioMarin Pharmaceutical. In that case, the FDA appeared to want more information on the durability of the treatment's effect, which had seemed to lessen in later stages of testing.

"Many people did learn something about the regulator's view on things," said Pipe, of the rejection.

"The FDA is clearly showing they want to see the totality of data because they want to assess the key outcomes, like predictability, reliability, durability and safety."

To date, two gene therapies for inherited diseases have been approved in the U.S.: a treatment from Roche for a type of blindness, and a spinal muscular atrophy medicine from Novartis. Both conditions are severe and, at the time of the approval, lacked treatment options.

Hemophilia, however, presents a different challenge. Patients with the disease, particularly more severe forms, have a very high treatment burden, but are able to control their worst symptoms with an array of drugs. Gene therapy could allow patients to go without regular factor replacement infusions and, researchers hope, free them from the ever-present threat of spontaneous bleeds.

But for patients already stable on medicines they know well, gene therapy could represent an uncertain bet. Scientists expect patients treated with one gene therapy generally wouldn't be able to receive a second dose of the same, or similar, treatment, potentially posing issues if a therapy's benefits wane over time.

Some patients might not even be able to receive treatment with gene therapy in the first place, due to pre-existing immunity to the virus used to deliver the corrected gene.

With HOPE-B, however, UniQure was able to show that likely won't be a major issue with its treatment. Early data had suggested that even patients whose immune systems produced antibodies to the virus used to deliver the therapy still benefited.

UniQure replicated that finding in HOPE-B, showing, in the 23 patients who had an immune response to the delivery virus, no correlation between neutralizing antibodies and Factor IX activity. One patient with particularly high levels of neutralizing antibodies did not respond.

Catherine Bollard, a director of the Center for Cancer and Immunology Research at Children's National Research Institute, called the trial "highly exciting" for that very reason, noting most gene therapy studies exclude patients with pre-existing immune responses to the delivery virus.

Some 40% of patients with hemophilia B might have immune responses to UniQure's delivery virus, according to Pipe, the study investigator, making HOPE-B's findings potentially important in proving some of those individuals could still benefit.

Shares in UniQure rose 7% on news of the HOPE-B trial results Thursday, pushing the biotech's market value up above $2 billion.

https://www.biopharmadive.com/news/uniqure-hemophilia-b-gene-therapy-hope-trial/589336/

Hospitals scramble to get ready for coronavirus vaccines

 Hospitals across the country are ramping up their efforts to figure out how to store, track and administer coronavirus vaccine doses as confidence grows that an effective vaccine could soon become available.

Hospitals will play a key role once a vaccine receives an emergency approval from the Food and Drug Administration, which could happen as soon as next month. They will move quickly to vaccinate their front-line healthcare workers and then their patients and surrounding communities.

But the task, like so much else related to the new coronavirus, is unprecedented.

Hospitals will need to be in constant communication internally as well as with their group purchasing organizations, state and federal government agencies and their local communities. Adding further complexity, the two leading vaccines have different storage requirements, and are administered via two shots spaced weeks apart.

Each state and territory, along with six major metropolitan areas, has its own distribution plan that has to be approved by the Centers for Disease Control and Prevention. Those 64 plans are generally based on what was drawn up for distribution of the H1N1 vaccine more than a decade ago.

Much of the planning is already underway, but only so much can be done until the FDA grants an emergency use authorization. Two vaccine candidates have so far been shown to be about 95% effective in preventing COVID-19 — one from Pfizer and BioNTech and the other from Moderna. Detailed data, however, are not yet available.

But hospitals and health systems have a lot to work out before that time comes.

Houston Methodist Hospital created a coronavirus vaccine task force back in August, and at first there wasn't a whole lot to discuss, Katherine Perez, an infectious disease specialist at the facility, said. The team includes members from the pharmacy, human resources, supply chain and operations departments.

The group now meets more regularly to prepare for when the FDA clears a vaccine. Discussions have centered around acquiring proper storage equipment, how to determine what order workers and patients will get the shot and how to educate people about its safety and effectiveness.

With healthcare workers first in line for a vaccine, the process for hospitals will start as soon as a vaccine is approved. Trump administration officials said this week they expect doses to be at the jurisdictions within 24 hours of approval.

"Hospitals have borne the brunt of this pandemic," said Julie Swann, health systems expert with North Carolina State University. "Hospital staff, the doctors and nurses, have just been overwhelmed in the ERs and the hospital wards. I'm glad they are among the priority groups for this vaccine and I'm hopeful that the vaccine will decrease the workload they have borne for this entire time."

A storage challenge

The storage requirements will depend on the vaccine or vaccines that receive authorization. The Pfizer shot, for example, requires a temperature of minus 70 degrees Celsius for transportation and long-term storage — which is unprecedented in provider healthcare settings.

Moderna's vaccine's temperature needs are less stringent. The shot must be stored long-term at minus 20 degrees Celsius, the same temperatures used for the MMR (measles, mumps and rubella) and chickenpox vaccines, which doctors have been administering for decades.

Moderna's product can last at refrigerator temperatures for 30 days, whereas Pfizer's is stable at those temperatures for only five days.

But without knowing if or when those vaccines or other candidates will receive an EUA, hospitals are doing their best to prepare for all scenarios.

Several difficulties complicate acquisition of the ultra-cold freezers needed to properly store a vaccine like Pfizer's. They can be hard to find right now, they're quite expensive and most facilities won't have another use for them.

"It's very, very infrequent where you're going to need to store something at this temperature, so that's a pretty big investment if you're only going to do it once." said Mark Howell, senior associate director of policy for the American Hospital Association.

These freezers are typically custom-made and cost between $5,000 and $20,000 depending on the size. They usually take four to six weeks to be delivered, said Soumi Saha, vice president of advocacy for group purchasing organization Premier.

Many states require their board of pharmacy to inspect the freezers and mandate that continuous monitoring of their temperatures be performed in case there is a failure. Companies that perform that 24/7 monitoring are saying they don't have the capacity to watch the ultra-cold freezers, Saha said. "So some who have purchased these ultra-low freezers have run into some regulatory barriers," she said.

Houston Methodist has purchased a large amount of subzero freezers in anticipation of cold storage needs, Perez said. Larger hospitals and health systems will have that ability. But smaller hospitals don't have the same resources.

Smaller and rural hospitals may have to wait longer to receive doses, which, because they are packed in dry ice, can only be transported on the ground. The minimum shipment of Pfizer's vaccine is 975 doses, which could present another problem for areas with lower populations, Saha said. "The logistical challenges are much more heightened in rural communities," she said.

Pfizer is shipping its vaccine in containers described as briefcases or pizza boxes. The doses are packed with the dry ice and can be kept for up to 10 days before needing to be repackaged or put into an ultra-cold freezer.

Those cases, however, can only be opened twice a day for up to one minute each time, meaning meticulous planning and execution will be required for efficient administration and avoiding waste, Saha said.

Administering the shot

Hospitals will begin giving shots to their own workers first, but most will have a tiered system for which staff will be first in line. Perez, of Houston Methodist, said her hospital has been going through the process of putting workers into categories based on factors like amount of direct patient interaction and which patients they tend to.

One consideration for hospitals is whether to make vaccination mandatory for staff, with certain exceptions for medical conditions. Houston Methodist may do so eventually, and already has the legal framework in place because workers are required to receive seasonal flu vaccinations already, Perez said.

Other hospitals aren't as likely to use a mandate. Atrium Health, a North Carolina-based system with about 40 hospitals, doesn't plan to, for example, said Lewis McCurdy, infectious disease specialist for the system. Saha said the legal implications for hospital liability are tricky, since healthcare workers will mostly be receiving the vaccine under an EUA and not full FDA approval.

The process will vary drastically depending on a hospital's location. "Montana's plan is going to be very different than the Philadelphia area's plan — they're just two totally different places," Howell, of AHA, said. "So the hope is that we're going to have all of those issues hashed out now."

Fewer than a third of the state plans for vaccine distribution give an estimate of the number of providers in the area eligible to give a vaccine, and few are doing extensive outreach to get providers to register as eligible, according to an analysis by the Kaiser Family Foundation.

Another difficulty is the need to track second doses. The Pfizer and Moderna vaccines require two shots several weeks apart, and others may have similar requirements. People will need to be directed to get the second shot, to get the correct vaccine and to get it at the right time.

The coordination required to achieve that is still being determined in many areas. Some state health departments will take up the task. Methods for reminding people to get their follow up dose could include text messaging and phone calls.

That could be complicated if multiple vaccines receive an EUA in a short time period. In that case, tracing includes not just when someone received a dose but also which vaccine they got.

Staffing is another huge concern. Health systems anticipate they will need to increase the number of providers available to administer doses. One estimate from the CDC estimates that one provider will be able to give only six shots an hour.

McCurdy said Atrium is forecasting its needs based on previous flu immunization campaigns. "We've been looking at that as a model of how we've done those vaccinations and immunization clinics before and what we think it will mean to do that for the coronavirus vaccine," he said.

Staff will also have to be trained on how to unpack, dilute and administer each vaccine that is approved.

Hospitals are not looking at just clinicians either. Hospitals are reviewing security plans for making sure doses are kept under lock and key, as they could be lucrative on the black and gray markets. Facilities are also reviewing how staff can be kept safe if members of the general public turn up at a site demanding to be vaccinated.

"There's a lot of concern around how you crowd control on Day One of being able to offer the vaccine," Saha said. "How do you protect the healthcare workers?"

Hospitals also have to consider contingency planning in case of a natural disaster or other emergency that may cause power outages or similar disruptions. Rural sites that are the only distribution location in a large radius in particular will have to establish backup protocols to keep dosages at the right temperature.

All of these issues are compounded as more doses are manufactured, said Cathy Bennett, CEO of the New Jersey Hospital Association. "I think the problems become more pressing as more and more vaccine becomes available and we start to move through the different distribution levels," she said.

Public health experts say multiple vaccines will be needed for widespread distribution, and having more to choose from will be helpful despite the potential logistical complications. A vaccine like Pfizer's may be sent to more populated areas with the resources to distribute it while others are prioritized for more rural areas, for example. And some may have better efficacy with certain populations, Swann said. "Having a portfolio of vaccines is not a bad thing," she said.

Community communication

Hospitals have already been playing an outsized role in educating the general public of the dangers of COVID-19 and the best methods for preventing spread.

Medical organizations have launched ad campaigns to urge people to wear masks, social distance and wash their hands frequently. Soon that communication may include prompting people to get vaccinated.

"We're familiar with this because the flu vaccine conversation comes every year and we spend a lot of energy and time trying to educate the public and healthcare leaders about the importance of getting your flu shot," Howell said. "So we're taking that model and ramping it up here."

Atrium has created a registry for patients and others interested in vaccine work, McCurdy said. "Our intent is to make sure that we try to educate the public about what a vaccine is, how does it come to be marketed in the sense of getting approval."

Polls suggest a broad swath of the U.S. population is skeptical of a quick coronavirus vaccine and will need convincing to receive a shot. The general public will likely at least want information on effectiveness for various groups of people and potential side effects.

Many health systems plan to have their own teams review drugmakers' data to do their due diligence and be able to offer the information from a trusted local source and not just federal agencies.

Communication from the federal government is expected to change under President-elect Joe Biden, whose term begins Jan. 20. Swann said she also anticipates more transparency around issue like adverse reactions, vaccination rates and production numbers.

"We need the FDA, we need the CDC both to do their piece which helps with that national messaging," Bennett said. "So from that perspective I think we need the federal government to do what it has always done. And their roles are to help build confidence in a vaccine."

https://www.biopharmadive.com/news/hospitals-scramble-to-get-ready-for-coronavirus-vaccines/589403/

COVID-19 may influence vaping, other substance use in young adults: study

 About 34 percent of young adults who completed a research survey said they've changed their vaping or substance use patterns in response to the pandemic, according to a Rochester, Minn.-based Mayo Clinic report published in Sage Open Medicine. 

With COVID-19 being a respiratory illness and vaping linked to lung damage, researchers set out to see how the pandemic may affect vaping and other substance use habits via a survey. More than 1,000 adults ages 18 to 25 completed the survey, which was sent to all Mayo Clinic patients who met the age requirement in April, and had visited an outpatient setting for any reason across Midwest locations within the four months before the survey. 

Key findings: 

• Nearly 70 percent of respondents reported an increase of alcohol consumption.
• Nearly 28 percent increased vaping use, while 44 percent reported decreases.
• About 47 percent said they reduced their tobacco use, while 24 percent reported an increase.
• Out of 140 who reported changes in marijuana use, about 39 percent said they used more, while 36 percent cut back. 

Researchers also compiled self-reported depression and anxiety information, and measured loneliness. A total of 269 respondents self-reported an anxiety disorder and 253 said they've experienced depression. 

"We saw that the more lonely, depressed or anxious these young people felt, the more likely they were to change their usage," Pravesh Sharma, MD, lead study author, said in a news release. "They may be trying to cope with social and emotional strain by adding or replacing one substance with another, especially if their access to other support is limited." 

https://www.beckershospitalreview.com/public-health/covid-19-may-influence-vaping-other-substance-use-in-young-adults-study-finds.html

Walgreens CFO: 'not worried about Amazon's online pharmacy'

 James Kehoe, Walgreens Boots Alliance's global CFO, expressed little concern about Amazon's recent entry into pharmacy Nov. 19 when he spoke at the Wolfe Healthcare Conference, according to Bloomberg.

Amazon on Nov. 17 launched a new online pharmacy allowing patients to purchase their prescriptions through the retail giant's website, offering discounts and free two-day delivery to Prime members. By the market close that day, Walgreens Boots Alliance shares dropped 9.6 percent, CVS Health shares dropped 8.6 percent and Rite Aid shares dropped 16.2 percent. 

During the conference, Mr. Kehoe called these declines "disappointing." He acknowledged Amazon as a serious competitor, but pointed out that their offering is only online. He also said mail prescriptions account for only about 10 percent of those written in the U.S.

Mr. Kehoe said he believes people are remaining loyal to physical pharmacies, and Walgreens has more than 9,000 locations where they can pick up their prescriptions or receive a vaccine.

"When you want to get your COVID vaccination, are you going to call Amazon or are you going to call Walgreens or CVS?" he asked during the conference.

https://www.beckershospitalreview.com/pharmacy/walgreens-cfo-i-m-not-worried-about-amazon-s-online-pharmacy.html

'Cost the biggest barrier to widespread coronavirus testing': survey

 Companies most often cited the cost of COVID-19 testing as the primary reason they weren't testing their workers, rather than test availability or turnaround times, The New York Times reported. 

In a survey conducted by Arizona State University and the World Economic Forum, with funding from the Rockefeller Foundation, companies most frequently cited cost and complexity as the biggest deterrent to testing. The survey included responses from more than 1,100 companies worldwide and was conducted from September to late October. 

Of those surveyed, 17 percent of companies said they were testing their workers. Half of those said they were doing so for asymptomatic workers, and half said they were testing workers at least once a week. 

At companies that aren't testing their employees, 15 percent cited availability as the primary issue, while 28 percent cited cost, and 22 percent cited complexity. Sixteen percent said it would take too long to get test results, the Times reported. 

Raj Behal, MD, chief quality officer at San Francisco-based One Medical, a primary care provider for large employers such as Google, told the Times that the lack of inexpensive tests had played a major role in limiting uptake.

"In our experience, companies that need to bring their employees in because they are essential or critical workers are regularly screening and testing employees for COVID-19," said Dr. Behal. "In general, though, cost may be the single most important barrier to widespread testing in the U.S."

PCR tests, which are the most accurate, cost about $100, according to the Times. Medicare covers the cost, but many private insurers don't. 

The survey found that companies with fewer than 25 workers were least likely to test their workers, with just 8 percent doing so. About 40 percent of companies with 1,001 to 5,000 workers were testing their workers, and about 60 percent of companies with more than 5,000 workers were testing, the Times reported. 

The survey also found that 37 percent of U.S. companies conducted contact tracing for workers who tested positive, compared to more than half of companies abroad. 

Zack Cooper, PhD, an economist at the Yale School of Public Health in New Haven, Conn., told the Times he had some concern that the survey could be biased because companies that didn't respond might differ from the companies that did. 

https://www.beckershospitalreview.com/supply-chain/cost-the-biggest-barrier-to-widespread-coronavirus-testing-survey-finds.html

CDC Escalates Warning for Cruise Travel, Urging Avoidance

 The U.S. Centers for Disease Control and Prevention has escalated its warning for cruise travel to the highest level and continued to recommend avoiding any trips on cruise ships worldwide.

The agency raised its warning to Level 4 from Level 3, citing “very high” risk of Covid-19 on cruise ships. Passengers are at increased risk of person-to-person spread of Covid-19 and should get tested and stay home for at least seven days after travel, according to its website.

“For most travelers, cruise ship travel is voluntary and should be rescheduled for a future date,” the CDC said.

The agency just last month provided a framework for cruise lines to plan for resuming operations. Under that order, passenger operations aren’t allowed during initial phases, and every ship must be certified by the CDC before travelers can board.

The eight-month shutdown has been catastrophic for the cruise line industry and its three biggest operators, Carnival Corp., Royal Caribbean Cruises Ltd. and Norwegian Cruise Line Holdings Ltd. Earlier this month, Carnival canceled additional trips as it works to meet CDC requirements, pausing U.S. operations through Jan. 31.

https://www.bloomberg.com/news/articles/2020-11-21/cdc-recommends-that-all-people-avoid-travel-on-cruise-ships

How long after exposure should testing be for most accurate results? Which test?

 Research suggests that diagnostic testing is more accurate a few days after symptoms start, or around a week after exposure to a person who is infected with COVID-19. Testing more than once can confirm negative results, when appropriate, and when tests are available.

During the wait for test results, it is essential for people who suspect they have COVID-19 or have been exposed to COVID-19, to take precautions and self-isolate when possible. It is also important to consider what type of test is being used to check for a COVID-19 infection, as this will likely impact how accurate the test is and how long it will take to get results.

Molecular tests are among the most accurate diagnostic tests currently available for detecting whether someone has an active COVID-19 infection. Molecular tests use methods such as RT-PCR (reverse transcription polymerase chain reaction) to detect genetic material from SARS-CoV-2, the virus that causes COVID-19, in respiratory samples such as nose and throat swabs.

Molecular tests have a higher risk of false negatives in the earliest days after exposure and symptom onset, according to an August 2020 publication in the Annals of Internal Medicine by researchers at John Hopkins University who reviewed 7 published studies on the performance of RT-PCR molecular tests. The researchers found that on average, the false negative rate was lowest around day 8 of an infection or 3 days after symptom onset (symptom onset is typically several days after an infection starts), with the false negative rate rising again as the infection continues. False negative test results in the early stages of infection are concerning, because other research (including studies published in Nature and the American Journal of Pathology) have found that COVID-19 patients can be most infectious to others in the early days of infection, when test results may be more likely to come back as false negatives.

Some testing policies recommend that people get tested twice to confirm a negative result. Repeat testing to confirm negative results can be particularly important for people who may interact with high-risk populations (ex. healthcare workers, caretakers), people who may interact with many others outside of their household (ex. an employee going back to the office, a student returning to in-person classes), and people who may need medical care for COVID-19 (e.g. elderly patients with underlying conditions).

Molecular tests are a relatively accurate type of diagnostic testing, and they have a lower chance of false negatives when conducted a few days after symptoms start, or approximately a week after exposure. A lower chance of false negatives does not mean there is no chance of inaccurate test results, so repeat testing may be recommended to confirm test results in certain situations. With all the ongoing research and development work on COVID-19 tests, pandemic testing guidelines may continue to evolve.

Background

There have been stories circulating in the media about how some people initially tested negative for COVID-19, only to test positive a couple days later. This has raised questions about what types of testing are most accurate, and when (during the course of an infection) is the most accurate time to test someone.

There are currently two main types: 1) diagnostic tests (including molecular tests and antigen tests), also known as viral tests, which indicate whether someone has an active infection; and 2) antibody tests, also known as serology tests, which indicate whether someone was likely to have had a COVID-19 infection in the past. An antibody test is not used to detect whether someone has an active COVID-19 infection, in part because it can take 1–3 weeks after infection for the immune system to produce antibodies.

Molecular tests are considered more accurate, in general, than the newer antigen tests for diagnosing the virus. Antigen tests detect specific proteins on the surface of the virus that causes COVID-19, and are more likely to miss an active infection compared to molecular tests. Antigen tests require repeat testing to confirm negative test results.

While molecular tests are currently considered the most reliable way to detect if someone has an active infection, there can be differences among the different types of molecular tests. For example, newer rapid diagnostic tests can provide results in less than an hour, compared to how most RT-PCR molecular tests provide results in a few hours to a few days. These rapid diagnostic tests are currently not as accurate, however, and researchers are investigating potential issues with the accuracy of rapid diagnostic tests.

https://learnaboutcovid19.org/questions/how-many-days-after-exposure-should-one-be-tested-to-yield-the-most-accurate-results-and-with-which-test/