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| Science & Technology |
| A Remarkable Leap Forward |
| 2020-04-22 |
| CJ via Instapundit In June 1981, the rapid-response newsletter of the Center for Disease Control, the Mortality and Morbidity Weekly Report, published news of an unusual pneumonia in otherwise healthy young men in Los Angeles. It would take four years from those first recorded cases of AIDS to the first FDA-approved test for HIV, and over a decade before the first rapid test. And so, if just a year ago, any of my colleagues had told me that we could have a point-of-care rapid test after mere months of a new pathogen’s emergence, I would have regarded it as hopelessly optimistic. Yet that is what the first-of-its-kind alliance between the U.S. biotechnology industry and the federal government has delivered. Just four months after the emergence of Covid-19, a dizzying array of tests is available to patients, physicians, and researchers. The initial tests, dependent on identifying the viral genome, have now been supplanted by much faster, much less expensive antibody tests. Unlike genomic tests, which require laboratory equipment and take several hours to complete, the new antibody-based tests are portable, and some don’t require any special materials other than saline. The antibody tests may answer questions not only about a patient’s current state but also about whether he has been exposed in the past by measuring antibodies that the immune system creates in response to the coronavirus. Finally, just today, the FDA announced that it is granting authorization for the first Covid-19 test that can be taken at home, affording an opportunity for many people in at-risk groups who have forgone testing up to now. By all measures, the emergency regime set up by the FDA has opened the floodgates of innovation on one of the most vexing problems of responding to a viral outbreak, and with great success. Unlike bacteria, which can be cultured conveniently in a petri dish, a virus is not easy to detect. The most reliable method uses a technique called polymerase chain reaction (PCR) to amplify the genomic material. But for this to be possible, at least part of the viral genome must be known. It wasn’t until the early days of 2020 that the first sequence of the coronavirus causing Covid-19 was published. PCR testing is time-consuming, expensive, and requires specialized equipment and expertise. While many university labs have both the personnel and gear to perform small-scale testing, the throughput of PCR diagnostics for identifying viral infections has always been limited. Perhaps the most frequent indication for viral PCR diagnosis—HIV testing and viral-load quantitation—accounted for only 3.13 million tests per year in 2017. By comparison, coronavirus testing exceeded this number by April 17. For sustainable, large-scale testing and sentinel surveillance—the periodic testing of vulnerable populations to act as bellwethers for resurgence—antibody tests are required. These tests can often be transported easily, either administered in the field or at bedside, and the results returned in as little as five minutes. More important, some antibody-based tests require no ancillary equipment. They can yield valuable information on whether the patient has ever been exposed to the virus. It often takes years to create a viable antibody test as accurate as PCR-based testing. But in less than six weeks, biotech companies—approached by the U.S. government through the White House-created public-private partnership—have already seen their efforts bear fruit. This is a tribute to the incredible creative potential of the biotech sector, but it also shows the power of free enterprise, unshackled by government bureaucracy. It took more than America’s best scientists to rise to the occasion: it took a regulatory regime to let them do so. The FDA—long derided by the biotech industry for its tedious and costly approval procedures, out of proportion with what’s necessary to protect public health—has stepped up its game in this time of need. If any good is to come out of the loss and heartbreak of this pandemic, we can hope that this newfound flexibility by America’s pharmaceutical and biotechnology regulator will be part of it. This is, IMO, very important - because, IMO, bioweapons' wars are just starting. |
| Posted by:g(r)omgoru |
| #8 Ignoring the fact that it was the govt (CDC/FDA) failure in contracting to do a national test device that led to the approvals for the private sector to create their own. A LONG time ago, and far, far away, I was trained to code lightbulbs (Univac). Toggle switch up, lamp ON. Toggle switch down, lamp off. That was the user interface. Easy enough for 16 switches. Then some code (mine!) didn't work. I was beaten by the instructor, them slammed by my classmates. I hadn't 'tested' the lamps before I released the code. The test usecase was 'turn each lamp on and verify it lights. Ever since then, no code without a test case plugged into the test framework. Why would anyone build and release a bug like this without the ancillary testing. |
| Posted by: Skidmark 2020-04-22 19:38 |
| #7 This is, IMO, very important - because, IMO, bioweapons' wars are just starting. This is why China must be made to regret this whole thing. |
| Posted by: rjschwarz 2020-04-22 12:07 |
| #6 Ah the global warming model for pandemics. From the Article: For sustainable, large-scale testing and sentinel surveillance... antibody tests are required. They touch on the required part, but don't elaborate in How they will make it required, the methodology of. I have my theories. But they do touch on the modeling they call sentinel surveillance. WHO Website: A sentinel surveillance system is used when high-quality data are needed about a particular disease that cannot be obtained through a passive system. Selected reporting units, with a high probability of seeing cases of the disease in question, good laboratory facilities and experienced well-qualified staff, identify and notify on certain diseases. Whereas most passive surveillance systems receive data from as many health workers or health facilities as possible, a sentinel system deliberately involves only a limited network of carefully selected reporting sites. My Emphasis: a sentinel system deliberately involves only a limited network of carefully selected reporting sites. Much like the global warming model. I <3 Dystopia |
| Posted by: mossomo 2020-04-22 11:00 |
| #5 ^Wait until we have to deal with an Iranian designed virus, JQC. |
| Posted by: g(r)omgoru 2020-04-22 10:18 |
| #4 This is, IMO, very important - because, IMO, bioweapons' wars are just starting. Most likely. The disinformation, propaganda and fake news are nearly as damaging as the reality of bioweapons. |
| Posted by: JohnQC 2020-04-22 09:48 |
| #3 Ignoring the fact that it was the govt (CDC/FDA) failure in contracting to do a national test device that led to the approvals for the private sector to create their own. |
| Posted by: lord garth 2020-04-22 09:43 |
| #2 I hope they'll have one for next year's flu bug. And the year after that. And the year after that.... |
| Posted by: Clem 2020-04-22 08:02 |
| #1 I’ve been very impatient about how long it’s taken to get useful data. I did’t realize how impressive it is. Now I know. |
| Posted by: trailing wife 2020-04-22 07:47 |