U.S. Companies Race To Catch Up In Coronavirus Tests The U.S. faces an uphill battle against the coronavirus and the reason is simple: There aren't nearly enough coronavirus tests to identify who has Covid-19 and where resources are most needed. were able to close well off of lows that day this work to change Now, after a slow and bumpy start, the race is on to deliver coronavirus tests across the U.S. in volume. In the last eight days, nine medical product companies have won the Food and Drug Administration's blessing for patient tests using unapproved products. Before then, only two government agencies held such emergency use authorizations, or EUAs, to peddle unapproved products to mass audiences. The tests already are rolling out and should increase in volume soon, although the companies are not disclosing the production volumes. Some of the companies already were distributing tests in other countries. The companies and government agencies using the federally sanctioned emergency protocol to roll out coronavirus tests are: GenMark Diagnostics (GNMK), approved March 19 DiaSorin Molecular, approved March 19 Abbott Laboratories (ABT), approved March 18 Quest Diagnostics (DGX), approved March 17 Quidel (QDEL), also approved March 17 Laboratory Corp. of America (LH) , approved March 16 Hologic (HOLX), also approved March 16 Thermo Fisher Scientific (TMO), approved March 13 Roche (RHHBY), approved March 12 Wadsworth Center, New York State Department of Public Health, approved Feb. 29 Centers for Disease Control and Prevention, approved Feb. 4 Further, on March 17, new FDA guidance allowed a number of other companies to sell coronavirus tests to a wide array of U.S. laboratories without an EUA. Under the new guide, laboratories that meet certain criteria can begin testing prior to asking for FDA authorization. Surge In Orders For Coronavirus Tests One of them is Salt Lake City-based Co-Diagnostics (CODX), which already has won approval to market its tests in Europe. "We've seen a tremendous surge in orders," Chief Executive Dwight Egan told Investor's Business Daily. "We are shipping to five continents." The new diagnostics aim for significantly faster return times than the initial coronavirus test developed by the CDC. When the CDC test first arrived on the scene Feb. 4, the results had to go to Atlanta. It could take up to 48 hours to process the test and confirm the results, Verdict Medical Devices writer Chloe Kent said in a recent report. Roche pledges to have results identifying a Covid-19 infection in 3-1/2 hours.Becton Dickinson (BDX), one of the companies affected by the relaxed March 17 guidance, says its test is complete in two to three hours. Co-Diagnostics aims to do better: 90 minutes. All of the companies have been quiet so far about the number of tests they're selling or how quickly they can ramp up production. Check Out Our Coronavirus Stock Market Crash Survival Guide Getting Coronavirus Test Approval In Europe Co-Diagnostics says it was the first company to receive a CE mark for its coronavirus test. A CE mark, or certification mark, allows a company to sell its product in Europe. CEO Egan wouldn't say how many coronavirus tests the diagnostic company has sold. One customer in Ecuador bought 30,000 tests, Egan said. The company uses a "compassionate pricing" model, he said. For example, Co-Diagnostics is selling its tests for $7 in India. That's much less than $40-$50 for rival tests, he said. Co-Diagnostics' coronavirus test involves two key steps. Once scientists receive the sample, they must extract the RNA and turn it into DNA. That takes about 30 minutes, Egan said. Then, the sample is run through a PCR machine. PCR, or polymerase chain reaction, is a technology used in molecular biologics. There are "thousands" of PCR machines in laboratories across the globe. A standard PC machine can read Co-Diagnostics' coronavirus test, Egan said. The company also pairs its tests with systems made by Bio Molecular Systems, a privately held company located in Australia. In total, that system can run samples from 46 patients at one time, Egan said. Other Coronavirus Test Systems Coronavirus tests from players like Roche and Becton Dickinson rely on their own systems. This means a hospital or laboratory can perform the test on site — assuming it already has that system. The Roche test runs on systems called Cobas 6800 and Cobas 8800. In eight hours, the Cobas 6800 system can run 384 tests and the Cobas 8800 can run 960 tests. Roche says the new coronavirus test is about 10 times faster than an earlier iteration the company created in January for officials in Wuhan, according to Bloomberg. In mid-March, Roche said 110 Cobas systems were at U.S. labs. Roche didn't return a request for comment from IBD. Becton Dickinson's coronavirus test runs on its own BD Max systems. There are 500 of those systems in the U.S. and another 500 in Europe, Becton Dickinson's Nikos Pavlidis told IBD. Pavlidis is vice president and general manager for molecular diagnostics and women's health at the company. In eight hours, one BD Max system can run 120 coronavirus tests, he said. Academic Centers Line Up, Too These tests don't need outside laboratories to diagnose Covid-19. Hospitals and academic centers can do them with a BD Max system in place, said Charles Cooper, global vice president of medical affairs and integrated diagnostic solutions at Becton Dickinson. That's key to limiting the spread of Covid-19. The respiratory illness is highly contagious and spreads through sputum. Sputum can discharge during a sneeze or cough. Emergency rooms and hospitals house rooms full of vulnerable people, proving a ripe ground for the virus to multiply. "If you don't have the ability to test, you have no way of understanding how to manage it," Cooper said. Meanwhile, academic researchers at Johns Hopkins, Stanford Medicine, Kaiser Permanente and the University of California have created their own coronavirus tests. They are using a lower bar known as a laboratory developed test. These LDT tests, according to the FDA, can only be performed at those sites. So, they won't be lucrative or broadly used, said Peter Kolchinsky, managing partner of RA Capital Management, which invests in health care and life sciences companies. Kolchinsky holds a Ph.D. in virology from Harvard University. He said it's not hard to develop coronavirus tests. That's why many labs have their own. "I think academic labs may only appear to be faster out of the gate, but broad-based testing will mostly be accomplished with commercially developed tests," he told IBD in an email. "If that's not evident now, it will likely become clearer in coming weeks." U.S. Coronavirus Tests Still Lag There are now more than 259,000 cases and more than 10,500 deaths worldwide, according to Worldometers. It's important to note, the number of confirmed cases is on the rise amid an increase in testing. Still, those numbers are problematic, says Tedros Ghebreyesus, director-general of the World Health Organization. "The most effective way to prevent infections and save lives is breaking the chains of Covid-19 transmission," Ghebrevesus said. "To do that, you must test and isolate. You cannot fight a fire blindfolded and we cannot stop this pandemic if we don't know who is infected." The U.S. has a lot of catching up to do. As of March 19, there were more than 16,000 cases of Covid-19 in the U.S., according to Worldometers. The respiratory illness has killed 220 people in the country. Yet, as of March 19 — the latest information on hand — the CDC and U.S. public health labs had completed 44,872 coronavirus tests. That amounts to little more than 1/100th of 1% of the U.S. population. Another estimate from the Covid Tracking Project says there were 111,638 coronavirus tests conducted in the U.S. as of early March 20, which puts testing closer in line with other countries. Either way, it's not enough, experts say. There has been a deeper push to test in other regions as well. Coronavirus Tests In China, South Korea, Italy According to Our World In Data, there had been 320,000 coronavirus tests in China, roughly 2/100ths of 1% of the population. Notably, the population in Wuhan, where the outbreak began, is 11.1 million. South Korea conducted 286,716 tests — more than half of 1% — while Italy performed 148,657 tests, or a quarter of 1%, as of late February to mid-March. Researchers in China first posted the genetic sequence of the new virus on Jan. 11 — about two weeks before the first case of Covid-19was identified in Washington state. The WHO test — which the U.S. government declined to use — deployed less than a week later. Today, the virus has spread to all 50 states and the District of Columbia. Confirmed cases are likely to surge as more tests become available. The issues surrounding diagnostic testing in the U.S. are twofold, Mike Pellini, managing partner at Section 32, told Investor's Business Daily.Section 32is a venture capital fund investing in technology, health care and life sciences companies. First, the American health care system doesn't use diagnostic testing to its fullest extent, Pellini said. For a long time, diagnostic companies have had to fight to gain insurance reimbursement for their products, a dynamic that often limits their uptake. Second, although U.S. policymakers could "see the light of the train coming through the tunnel back in mid-January," they've only just begun to react. "We are trying to cram two to three months' worth of preparation into days," he said. Lawmakers Call Coronavirus Response 'Frightening' U.S. Sen. Patty Murray, D-Wash., questioned in a recent letter why the WHO coronavirus test wasn't used in the U.S. A coalition of 60 House Democrats called for an improved response to Covid-19 from the Trump administration. The group called the response thus far "frankly frightening." Ultimately, the lack of coronavirus tests in the U.S. should serve as a wake-up call, Pellini said. "My hope is, going forward, this never happens again," he said. "Meaning, shame on us if as a country we do not completely change the way we value diagnostics." Is There A Financial Opportunity In Coronavirus Tests? It's hard to predict how many coronavirus tests the U.S. will need. Evercore ISI analyst Vijay Kumar tried to map out the opportunity. He expects the U.S. to need 1 million to 2 million tests in the near term. The majority of this demand will come from patients experiencing symptoms consistent with Covid-19. The remainder would come from influenza cases. In general, molecular diagnostics companies receive $40-$50 in reimbursement for these types of tests, he said. He used a less-bullish $30 estimate in his model. That comes out to a $30 million to $75 million U.S. opportunity for coronavirus tests, Kumar said in a recent report. GlobalData director of epidemiology Kasey Fu expects the burgeoning efforts by academic centers and companies to help uncover "silent" cases of Covid-19 that don't exhibit symptoms but are still highly contagious. "The next few weeks will be pivotal for the U.S. to understand the true extent of Covid-19 spread in the country," she said in a recent report. Follow Allison Gatlin on Twitter at@IBD_AGatlin. https://www.investors.com/news/technology/coronavirus-tests-lagged-companies-racing-to-fix/