In early April, Chester County made headlines by adopting a promising new tool to manage the coronavirus pandemic: testing essential workers’ blood to see who had developed disease-fighting antibodies to the deadly virus.
The plan was to eventually test every resident of Chester and Delaware Counties — about one million people — to better understand the scope of COVID-19, including asymptomatic cases, and how long antibodies might provide an immune defense.
At the time, antibody detection tests were just coming onto the market. Experts assumed that the blood proteins conferred some level of protection, but they couldn’t say how strong that protection was or how long it lasted. They still don’t know.
Chester County’s plan to start by testing first responders and health-care providers had several benefits in theory. It could offer at least limited reassurance to those with signs of a past COVID-19 infection. It might identify workers who had just recovered so they could go back to work without infecting others. It might even identify some asymptomatic carriers with a current infection.
The program began May 7, then was quietly shelved about a month later — despite Chester County’s having spent more than $13 million in federal pandemic aid for the tests.
Only 13,231 people were actually tested by the county, officials say. An additional 8,678 were tested by nursing homes and other facilities. About 57,000 unused tests are now in storage, according to Michael Murphy, the emergency services department director who oversaw the testing program.
So what happened?
County officials have insisted the initiative ran smoothly. “Nothing went wrong with the antibody testing program,” Chester County spokesperson Rebecca Brain said in a statement Wednesday.
But internal emails and interviews with people involved in the program show that the newly developed, unapproved antibody tests, sold to the county by a politically connected, neophyte biotech firm called Advaite, may have been generating wildly inaccurate results.
Renée Cassidy — who resigned in July as the county’s public health physician in protest over the Advaite tests — said that about two weeks into the program, the percentage of people testing positive for coronavirus antibodies “skyrocketed” well beyond what was plausible, given the prevalence of the disease in the area.
That, Cassidy said, suggested the tests were producing false alarms — called false positives — and the county was incorrectly informing people that they might still be contagious, or had previously had the virus.
A less likely possibility, Cassidy said, is that nurses or lab technicians somehow began misreading the tests on a large scale.
In any case, county officials rejected Cassidy’s recommendation to tell more than 6,000 people whose tests were in a suspicious batch that their results might be wrong.
"I wanted to send an email ... saying we don’t think these results are necessarily accurate,” Cassidy said in an interview this week.
Cassidy said her superiors “expressed a worry it would undermine the health department and the county in terms of believing anything we said or did. My counterargument was … it would look like we were trying to cover this up.”
Charles Catania, a primary-care physician in West Chester, knew something was amiss when worried patients started flocking to his office after testing positive for antibodies through the county program. Some of them had received emailed results that stated: “You may have COVID-19. You are likely contagious. You should isolate yourself at home.”
To verify the county’s results, more than 75 of Catania’s patients gave nasal samples for analysis with the more accurate type of test that diagnoses current infection. It involves molecular analysis in a lab to look for the virus' genetic material.
Most of those 75 patients had no symptoms. With the molecular diagnostic test, only one tested positive.
“What the hell is going on here?” Catania recalled wondering. “We were getting all these false positives. There were people scrambling to figure out whether they really have” the infection that has killed nearly 200,000 Americans.
One health-care worker who got tested at the county site in a Longwood Gardens parking lot said she was alarmed by the email she received with the results later that day.
“It says this basically means you have COVID because these are the antibodies that your body first releases to attack the infection. … I freaked out and called a doctor right away,” said the health-care worker, who asked not to be named because she works closely with county staff.
She turned out not to be infected. Several of her colleagues had similar experiences.
Murphy, the emergency services director, said the reliability of Advaite’s test was assessed by health department officials.
Asked why the testing was halted, Health Department Director Jeanne Casner said it was because the county was able to obtain molecular diagnostic tests, which were in short supply across the country in the early months of the pandemic. The molecular tests detect only a current infection.
“Once we had all our supplies,” she said, “our whole goal was to wind down antibody testing and ramp up” diagnostic tests.
A local connection
Advaite was founded three years ago by Karthik Musunuri while he was majoring in pharmaceutical marketing at St. Joseph’s University.
Musunuri, 26, initially agreed to an interview for this story but stopped responding to emails.
Originally, Advaite — from the Hindi word for “peerless” — aimed to develop a therapy for a rare eye complication of certain cancer treatments. The company’s chief scientific officer, Sandeep Jain, is a professor of ophthalmology at the University of Illinois. And Musunuri’s father, Shankar, a biotech veteran, founded Ocugen Inc. in 2013 with the still-unrealized goal of “commercializing transformative therapies to treat blindness diseases,” according to the company website.
Advaite had scant capital but big plans.
“The market potential exceeds $300M, and we are well poised to reach certain inflection points that can significantly drive the value of the company,” Musunuri wrote on a website for biotechs seeking “angel” investors.
In October 2017, Musunuri was honored as a Forbes magazine “30 under 30” scholar at a summit for young entrepreneurs in Boston.
In March, when the pandemic basically shut down the United States, Advaite pivoted to what its news release called “developing novel diagnostics.” Musunuri’s younger brother, Vinny, a student at the University of Southern California, became Advaite’s manager of corporate strategy, according to his LinkedIn page.
A stroke of luck followed that pivot. Pennsylvania Sen. Andy Dinniman (D., Chester County), who has spearheaded conferences with local biopharmaceutical executives, was looking to help the county deal with the shortage of diagnostic tests.
“I made some inquiries,” he recalled during an interview. He learned that Advaite was partnering with two companies — Exton-based Frontage Laboratories and its affiliate, Philadelphia-based Frontida Biopharm — to develop and manufacture antibody tests.
The test device looks sort of like a pregnancy test, but it analyzes blood from a finger prick instead of urine. And while molecular diagnostic tests take days or weeks to get results back from a lab, the antibody results — indicated by colored lines — could be read in 15 minutes at the test site.
Dinniman thought highly of the Musunuri family. The senator had employed the younger son as a summer intern, and knew the father through biotech circles. The elder Musunuri had contributed $4,000 to Dinniman’s campaign committee between 2012 and 2020, records show.
“Shankar is a most respected leader in the biotech field,” Dinniman said. “Anything Advaite was doing, he was involved.”
Indeed, in April, Ocugen notified the Securities and Exchange Commission that it had a “collaboration” with Advaite. Shankar Musunuri’s firm would be paid up to $375 an hour to work on projects for his son’s firm. Ocugen would also receive royalty payments based on sales of the test kit.
Dinniman connected Advaite’s young founder with county officials.
“I said to the county that if they’re looking for a test, here’s one possibility,” Dinniman recalled. “Whether it was a valid test would be determined" by county health officials.
Around the world in March and April, governments were investing heavily in antibody tests, most made in China. There was talk of “immunity passports” that would allow people with antibodies to work and travel freely. More than a few countries, such as Britain and Spain, wound up with embarrassing fiascoes because the technology didn’t work.
The U.S. Food and Drug Administration was so keen to encourage the development of antibody tests that in mid-March it said companies didn’t even need to apply for an “emergency use authorization,” which involved a relatively cursory regulatory review.
That led to a flood of unreliable and fraudulent products. So in early May, the FDA backpedaled: Companies had to submit their validation data within 10 days of marketing, and it had to be worthy of emergency approval.
Although Karthik Musunuri’s discussions with Chester County officials began about the same time the FDA suspended its oversight of antibody tests, he told the county he was seeking an emergency authorization. According to Advaite’s website, he still is.
On March 17, an application was filed to trademark Advaite’s test as RapCov.
County officials exchanged a flurry of emails — some later obtained under the state’s Right-to-Know law by a West Goshen activist named Margie Swart and shared with The Inquirer. Swart leads a Facebook group dedicated to ferreting out waste, fraud, and abuse in local government.
The county health department said RapCov claimed to correctly identify 89% of people with antibodies, and 100% who lacked antibodies.
Officials debated whether to get health systems to buy in, and whether to eventually test everyone in Chester and Delaware Counties. (Delaware contracts with Chester for public-health services.)
There was urgency.
“How fast can you get me some samples for us to test?” Murphy emailed Musunuri on March 23. “Once tested we would like at least 10,000 kits to start, with the option to order much more.”
“We are obviously inundated with orders but I will make sure to prioritize our community as best I can,” Musunuri replied, saying the samples could be picked up from his home in Chester Springs.
A month later, Murphy emailed Musunuri: “Besides us, who else is using your test (US or international)?”
Musunuri responded that the county was essentially its sole customer. “Due to the capacity, since the county order, we have not taken anyone else,” he wrote.
The county intended to apply for reimbursement under the new federal CARES Act, but the emails show that even before getting the aid, the county made a deal with Advaite for one million tests at $20 each — $20 million in all. The county wound up paying $13.2 million to Advaite, which delivered 102,000 tests, Murphy confirmed in an interview.
The invoice Musunuri sent the county stated the tests were “non-returnable and payments non-refundable.” It’s not clear whether the county will seek to recoup any payments.
“We asked them in late June or early July to stop sending tests,” Murphy said.
The public health emergency enabled the county to award contracts without seeking bids.
Even so, Cassidy, the county’s former public health physician, said she found it odd that county officials were so eager to purchase tests from Advaite, given the firm’s limited track record.
She said Murphy, who handled the purchase and kept County Administrator Robert Kagel in the loop, was “dead set on plunging forward."
When the announcement of the county’s antibody testing program generated positive press in early April, Murphy forwarded the news clips to Musunuri.
“You should be very proud!” Murphy emailed.
On Thursday, after The Inquirer provided a detailed summary of the information in this story to the county, Brain, the spokesperson, emailed that there were inaccuracies, but she could not specify them and could not provide access to officials who could be specific until next week.
Chester County’s apparent misfire has a larger context.
The Trump administration has ceded pandemic mitigation decisions to local and state governments. At the same time, federal regulations have been relaxed, and federal aid has rained down. Academics and journalists alike have reported on the resulting well-intentioned but misguided initiatives, as well as fraud and waste.
“When you’re buying something and you don’t know if it’s going to work, and you’re doing it fast, the risk that you get it wrong is high,” said Trevor Brown, a government contracting researcher and dean of the college of public affairs at Ohio State University.
In normal times, Brown said, officials weigh trade-offs between cost and quality and don’t overvalue speed of delivery. “But in a pandemic, you need that stuff now. You’re under political pressure to calm your stakeholders.”