Skepticism led woman to send dog DNA to Orig3n

By Jeannette Hinkle / Daily News Staff

Posted Oct 23, 2020

Genetic Counselor Katie Stoll was skeptical when she bought an at-home genetics test kit from a company called Orig3n in December 2017.

The kit was advertised to parents looking to better understand their children’s genetic profiles.

“From food allergies to natural abilities for language and learning, the results help you get to know your child even better,” Orig3n said of its “Childhood Development” genetic test kit.

- Related: Orig3n violated rules for years before being approved for COVID-19 testing

Stoll purchased the test kit not to learn more about her child, but to learn more about Orig3n, a Boston-based consumer genetics company that pivoted to COVID-19 testing last spring and is now facing sanctions from the Centers for Medicare & Medicaid Services after the lab produced at least 383 false positive coronavirus test results last summer.

Stoll, working on her own, eventually submitted two samples to Orig3n for analysis. First, she sent the company a swab from her mixed-breed dog, Ginger, then later, a sample of tap water from her kitchen sink. Neither of the samples were identified as nonhuman by Orig3n lab employees.

Stoll is a board-certified genetic counselor who now works as executive director for the Genetic Support Foundation, a nonprofit based in Olympia, Washington, that aims to provide independent information about genetics.

In a 2018 complaint she wrote to the Massachusetts Department of Public Health — spurred by Orig3n’s failure to identify the dog and tap water samples as nonhuman — Stoll said that in ordering the kits, she as a consumer wanted to see if the company was forthright about the potential risks and limitations of the kind of genetic testing it offered. She also wanted to know if the company required a consent form, since the test was for children.

Orig3n CEO Robin Smith said last week that while the type of DNA analysis his company offers is relatively new, it provides one tool among many to help people make decisions about their lives.

But direct-to-consumer genetic testing continues to be viewed with skepticism in the scientific community.

Sarah Nelson is a senior research scientist at the University of Washington specializing in the ethical and social implications of genomics — the study of all of an individual’s genes — and direct-to-consumer genetic testing. The university’s molecular biology and genetics programs were ranked sixth in the world by U.S. News & World Report.

There’s a wide range in the quality and validity of direct-to-consumer genetic testing companies and the products they offer, Nelson said, but overall, the genetics community has reservations about genetic tests billed as being able to advise people about their predisposition to certain traits.

“There’s skepticism that we even understand the genetic basis of diseases and traits well enough to be reporting back to individuals, just the scientific credibility,” she said. “Maybe in 20 years we’ll know enough to give people that type of information, but right now, it’s premature.”

Lindsay Farrer, a medical geneticist and Boston University’s chief of biomedical genetics, said direct-to-consumer genetic testing often misleads customers because the companies use population-level data from studies about genetic links to certain traits or diseases and wrongly apply that data into risk assessments for random individuals.

Usually, the studies used by companies like Orig3n are based on very specific populations, such as older white European women, that don’t always represent the range of people ordering the tests.

“The information they give, even if it’s of limited applicability, the accuracy of it is, at best, modest,” he said. “I guess my conclusion would be buyer beware.”

‘It’s downright chicanery’

Stoll watched Orig3n advertise at sporting events including NFL and NHL games with concern, but it was the company’s online advertisements for its Childhood Development test kits that prompted her to place an order herself.

Stoll thinks consumer genetic test kits like the ones offered by Orig3n also push important ethical boundaries, especially when it comes to children. Children can’t consent to learning information about their DNA that has the potential to shape the rest of their lives, she said, even if their parents can.

Stoll said she didn’t trust Orig3n with her child’s DNA or her own, so instead, she swabbed the cheek of her dog, Ginger. After sending the kit containing Ginger’s DNA to Orig3n, she got a full report back from the company on Jan. 18, 2018, about the dog’s genetic profile, which showed, among other things, that she was likely to have mild struggles with reading.

She said she gave the company a second chance. She ordered another Childhood Development kit, and sent in a sample of tap water from her kitchen sink on March 17, 2018. Again, she got a full report back from Orig3n. According to the report, the tap water would need longer to develop skills required for language learning.

Farrer laughed out loud when he learned that Orig3n had returned profiles for Stoll’s dog and the sample of tap water from her kitchen sink.

“I can’t think of a word to describe it, but it is beyond incompetence,” he said. “If that’s the case, they are not competent to do what they’re doing. If they’re getting DNA out of tap water, then that’s bacterial DNA and that is clearly different from human DNA.”

“If they can’t generate results reliably, then it’s worse than snake oil,” Farrer said. “It’s downright chicanery.”

A lab in transition

The company’s report on Stoll’s sample of tap water was signed by Orig3n’s then-lab director, a board certified geneticist, which deeply disturbed Stoll.

She reached out to the lab director, who told Stoll that she had resigned from the company, and that when the tap water sample was submitted, Orig3n was transitioning to a new director.

The lab director “was not onsite at the laboratory when the test was performed and she had very limited visibility into the testing operations at that time,” Stoll wrote in her complaint letter.

Stoll told the DPH that she was concerned about Orig3n’s ethics, it’s technical proficiency and it’s professional oversight.

“I hope that (the Centers for Medicare & Medicaid Services) will investigate these concerns and act as necessary in the interest of public safety,” Stoll wrote in the complaint, dated Sept. 24, 2018.

In an emailed response to a similar complaint Stoll sent to the federal Food & Drug Administration, Tim Stenzel, writing on behalf of FDA Commissioner Scott Gottlieb, said the agency takes reports like hers seriously.

“We will evaluate this matter to determine what follow-up action is appropriate,” Stenzel wrote. “The type and extent of any follow-up is dependent upon the nature of the problem, the possible impact on the public health, and the availability of our resources.”

A DPH investigation into Orig3n conducted before Stoll filed her complaint found the lab had fixed lab issues that led to the company’s failure to identify dog DNA as nonhuman.

In April 2020, despite three previous investigations by other agencies into quality control problems in Orig3n’s lab, the FDA gave the company emergency authorization to conduct coronavirus testing. In May, the DPH recommended Orig3n as a testing option for nursing homes facing deadly outbreaks.

For Stoll, the eventual finding by regulators that problems at Orig3n’s lab led to the reporting of hundreds of false positive COVID-19 tests showed a dangerous weakness in how governmental agencies are overseeing labs that test human samples, whether those tests are used for diagnostic purposes or personal betterment. False diagnostic test results can pose a danger to patients because doctors make medical decisions based on those results.

That weakness needs to be addressed so Americans can trust the results of their lab tests, especially amid a deadly pandemic, she said.

“I feel discouraged,” Stoll said last week. “What does the system mean when you do things the right way and you file complaints to the right agencies and nothing happens, and then something horrible like this happens? It just feels terrible, really.”

 

Orig3n violated rules for years before being approved for COVID-19 testing; fourth investigation showed lab put patients at risk

By Jeannette Hinkle / MetroWest Daily News / and Trevor Ballantyne / Needham Times

Posted Oct 15, 2020

Posted Oct 15, 2020 

After facing investigation three times for quality control problems, consumer genetics company Orig3n this spring was allowed to administer COVID-19 tests in several states. By summer the Boston company halted testing in Massachusetts after producing hundreds of false positive test results.

Bailey the dog likely would be a skilled basketball player or boxer. Ginger the dog probably would experience mild trouble learning to read. And a few drops of kitchen sink tap water might need longer to develop skills required for language learning.

Those were a few of the findings of consumer genetics tests conducted by Boston-based startup Orig3n, a company that promises to tell customers how their DNA makeup could influence everything from cognitive abilities to sleep needs.

In all three cases, the company failed to identify the nonhuman samples sent to its labs by customers skeptical of Orig3n’s products.

By the time the Massachusetts Department of Public Health received its second complaint in September 2018 about Orig3n’s inability to identify canine DNA as nonhuman, a complaint that was also sent to the U.S. Food & Drug Administration, the company had generated red flags since 2016 at state and federal agencies tasked with ensuring labs that test human samples are operating properly, according to hundreds of pages of documents obtained by The MetroWest Daily News and the Needham Times through a public records request.

Despite the history of investigations, in the spring, as COVID-19 spread across Massachusetts with fatal consequences — especially among residents of long-term care facilities — the FDA gave Orig3n an emergency authorization to perform coronavirus tests. And the DPH and the Centers for Medicare & Medicaid Services gave the company permission to add virology and immunology as specialties.

The DPH even recommended Orig3n as a testing option to nursing homes struggling to contain deadly coronavirus outbreaks across the state.

By August, however, the company had halted its COVID-19 testing operation when it was investigated once more, this time after DPH staff noticed Orig3n’s lab was putting out an unusually high number of positive coronavirus test results.

On Oct. 2, the Centers for Medicare & Medicaid Services sent a letter to Orig3n’s lab director informing him the agency had suspended the company’s certificate to operate a clinical lab, and that it recommended a full revocation of that certificate. Orig3n has a right to appeal the decision within 60 days.

DPH investigators later found the company sent out at least 383 false positive COVID-19 test results to patients across the state between July 30 and Aug. 2. The false results put patients in “immediate jeopardy,” according to the DPH.

DPH investigators found serious deficiencies in the Boston-based lab’s coronavirus testing operation, some of which mirrored quality control issues found during previous investigations in 2018 and 2019.

But the pandemic offered an opportunity for Orig3n to fill a glaring need for increased COVID-19 testing capacity across the nation.

“When COVID-19 became a public health crisis,” Orig3n CEO Robin Smith wrote in an email on Tuesday, “we decided to dedicate our resources to providing testing for high-risk and high-need populations across the country, including school students and faculty, nursing home residents and staff, and private and public employers.”

Smith did not answer a question about why the company was qualified to conduct coronavirus testing in light of its history of lab violations.

Investigations begin

Centers for Medicare & Medicaid Services, which enforces federal regulations for clinical labs testing human samples, first investigated Orig3n’s Massachusetts lab on Jan. 31, 2018.

While documents don’t say what prompted the investigation, they show a federal surveyor found a litany of deficiencies at Orig3n’s Waltham lab, which the company had recently acquired.

The surveyor found the lab didn’t have a system in place to ensure test results and other patient-specific information were accurately and reliably sent to their final destinations. The lab also failed to show that a legally authorized person made requests for the genetic tests processed by Orig3n.

Four months later, shortly after the company told federal regulators it had corrected deficiencies outlined in the January investigation, the Massachusetts DPH sent its own surveyor to inspect the company’s lab operation, according to DPH documents.

The DPH’s May 2018 investigation was sparked by a May 2, 2018, report by NBC 5 in Chicago. The news organization sent dog DNA to similar at-home genetic testing companies and found that Orig3n was the only company not to flag the dog sample as unreadable.

The DPH surveyor ultimately concluded that Orig3n had corrected issues with its testing process when it underwent the Clinical Laboratory Improvement Amendments (CLIA) certification established by the Centers for Disease Control and Prevention, which occurred after NBC 5 sent the dog DNA for processing. The surveyor concluded no further action was required.

Quality control lacking

In 2019, Centers for Medicare & Medicaid Services sent out another surveyor for the third investigation of Orig3n by lab regulators in two years.

The surveyor’s visit came shortly after Bloomberg published an article in which 17 former Orig3n employees alleged the company’s consumer genetic testing kits, which ranged in price from $29 to $298, sometimes failed to work as advertised and often were contaminated or inaccurate.

The surveyor found a long list of quality control issues at the lab, which had by then moved from Waltham to Boston’s Seaport after scoring millions of dollars in venture capital from backers. One of those backers, LabCorp, operates one of the largest clinical lab networks in the world.

Echoing findings by previous investigators, basic records were inaccessible or missing, including reports that showed equipment and instruments were properly maintained and tested according to manufacturer guidelines. The surveyor also found the lab had failed to ensure that the temperature of refrigerators and freezers that contained patient samples and reagents were monitored and logged, a key protocol for making sure testing functions correctly.

Roughly four months after Orig3n’s lab director told regulators the company had corrected or would correct the issues identified in the 2019 investigation, the FDA sent a letter notifying the company it was approved for inclusion under an umbrella Emergency Use Authorization to conduct certain types of COVID-19 testing.

In a press release announcing the news, Orig3n said the company’s coronavirus testing would be available to authorized health care providers and institutions nationwide.

FDA spokesperson Jim McKinney said Tuesday the agency authorizes tests, not labs.

“Qualifying a lab as CLIA certified would be a function of the Centers for Medicare & Medicaid Services,” McKinney wrote in an email.

A Centers for Medicare & Medicaid Services spokesperson said Wednesday that the FDA has sole authority to issue emergency authorizations, but as a CLIA-certified lab, Orig3n was authorized to conduct high-complexity testing.

The spokesperson also said the agency affords labs due process and an opportunity to address allegations of noncompliance. When Orig3n began COVID-19 testing, the spokesperson said, the Massachusetts DPH had deemed the lab fully compliant.

In May, both the Massachusetts DPH and Centers for Medicare & Medicaid Services concluded after “offsite” surveys that the company could add virology and immunology as specialties. The agencies found the company was in “full compliance” with applicable state licensure and CLIA requirements.

Spokespeople for both Centers for Medicare & Medicaid Services and the DPH said in statements the offsite approvals for the addition of specialties to CLIA-certified labs are standard procedure. Usually, the surveys involve a desk review of documentation, including procedures, personnel qualifications and training.

With approvals in place, Orig3n began conducting coronavirus testing across Massachusetts, and offering its COVID-19 testing services in other states.

In a memo to nursing homes last updated on June 1, the DPH recommended the company’s testing services to long-term care facilities sprinting to meet a May 25 deadline to test 90% of residents and staff for the virus. The company eventually would conduct coronavirus testing for at least 60 nursing homes statewide, most of which were dealing with deadly outbreaks.

Test results prompt fourth investigation

Records show federal regulators visited Orig3n twice in August after the company reported an unusually high number of positive COVID-19 test results. Earlier in the month, the company voluntarily agreed to halt COVID-19 testing.

On Aug. 8, Sandra Smole, director of the Massachusetts State Public Health Laboratory, sent an email to public health leaders in other states alerting them about Orig3n’s high rate of positive COVID-19 tests. Smole classified the email’s importance as “high” and sent it to public health officials in California, Michigan, Ohio and North Carolina, as well as the Association of Public Health Laboratories.

“The Orig3n Inc. Laboratory Director indicated that they also test specimens from your jurisdiction, and so we wanted to make you aware of this situation,” Smole wrote. “At this time, we have no specific information indicating that samples from your state have been impacted.”

DPH documents did not indicate whether there were problems in other states with Orig3n COVID-19 test results.

On Aug. 26, the Massachusetts DPH Division of Health Care Facility Licensure and Certification finished its investigation into Orig3n’s coronavirus testing operation, and found dangerous deficiencies in how the lab conducted its work.

According to the report, the lab failed to document basic sanitation measures, including the daily sanitizing of lab benches and equipment used in COVID-19 testing. The lab’s system for detecting potential errors in test results was inadequate and lacked controls that would detect contamination.

Both Orig3n’s lab director and its CEO confirmed in interviews with investigators that, while the lab tracked daily positivity rates, it failed to assess or correct any problems flagged by higher than normal positivity rates.

The report also slammed Orig3n’s lab director for failing to provide “overall management and direction,” which meant the director was unable to ensure the accuracy and reliability of patient test results.

Orig3n began coronavirus testing on April 27. Before it suspended COVID-19 testing in early August at the state’s request, the company had reported 23,513 results.

The Massachusetts DPH ultimately found the company sent out at least 383 false positive results to patients, according to agency documents, but because not all test samples processed by Orig3n were retested, that number could be higher.

It’s also unknown how many false negative coronavirus test results the company released to people, because false negative test results are harder to detect than false positives.

The DPH told Orig3n’s lab director in a Sept. 4 letter that the company’s deficiencies posed “immediate jeopardy to patient health and safety,” meaning the lab caused, was causing, or was likely to cause “serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public.”

Orig3n has not yet restarted coronavirus testing, according to Orig3n’s CEO. The company is waiting for “resolution of our regulatory discussions with CMS (Centers for Medicare & Medicaid Services) and the state of (Massachusetts),” Smith said in a statement to Gannett New England.

In an interview for a previous story about the DPH’s investigation into Orig3n’s coronavirus testing, Dr. Michael Mina, an assistant professor of epidemiology at Harvard T. H. Chan School of Public Health who has experience running laboratories, said mistakes do happen at labs, but “they don’t usually require an investigation.”

“It’s just important to keep all these things in check,” Mina said in September. “The frenzy to do coronavirus testing has been so extreme. I don’t think labs should be immediately shut down for mistakes, but we have to remain vigilant to ensure that all the testing that is being done is up to the highest standards.”

POLITICO Massachusetts Playbook: Holmes pushes POLICE REFORM — State UNEMPLOYMENT fund in the RED — GALVIN calls for more MAIL-IN BALLOT funds

 

BY STEPHANIE MURRAY GOOD MORNING, MASSACHUSETTS. NEXT YEAR'S BOSTON RACES BEGIN TAKING SHAPE — At least one Democrat is already eyeing Boston City Councilor Michelle Wu's at-large seat on the council if she runs for mayor in 2021. Wu has neither confirmed nor denied reports that she recently told Boston Mayor Marty Walsh she plans to run for mayor next year. But Walsh's confirmation of a phone call he had with Wu about the 2021 race was enough to spark Jay O'Brien, a Charlestown Democrat, to begin exploring a run for the council. O'Brien is a former State House aide who cited housing and transportation as two key issues facing the city in a phone call last night. It's bound to be a busy year in Boston — City Councilor Julia Mejia reacted to the news of Wu's likely mayoral campaign by predicting a crowded field up and down the ballot. Mejia cautioned that Boston political watchers should wait to see how the contest shapes up before choosing sides. "I predict 5-6 mayoral candidates, 20 At-Large candidates, at least 1-3 for each district and with so many people running we'll have lots of viable options. Wait to see who gets on the ballot, best represents your values then decide who you want to support. Be informed," Mejia wrote in a tweet on Monday. Already running for another seat on the council is Kendra Hicks, a community organizer and activist who is running for incumbent Councilor Matt O'Malley's seat representing West Roxbury and Jamaica Plain, along with parts of Roslindale, Roxbury and Back of the Hill. Hicks is director of radical philanthropy at the nonprofit Resist, according to her website. FIRST IN PLAYBOOK: LESSER TO FUNDRAISE WITH 'VEEP' STAR — State Sen. Eric Lesser will hold a virtual fundraiser later this month with David Mandel, show-runner for the HBO political series "Veep" and executive producer of "Seinfeld" and "Curb Your Enthusiasm." Also on the guest list is actor Timothy Simmons, who played Jonah Ryan in "Veep." Lesser consulted on "Veep" for nearly a decade, drawing on his experiences as a White House aide and President Barack Obama campaign alum. Lesser's role was to help the show’s writers keep things realistic, he told CommonWealth Magazine before the final season aired last year. Suggested contributions range from $50 to $500 for the Sept. 22 fundraiser, according to an invitation. Have a tip, story, suggestion, birthday, anniversary, new job, or any other nugget for the Playbook? Get in touch: smurray@politico.com. TODAY — Boston Mayor Marty Walsh kicks off the virtual “Mass Voter Table Census Phone Bank” and is a guest on WBZ's “Nightside with Dan Rea.” Former Gov. Bill Weld and former White House Counsel to President Richard Nixon John Dean discuss political courage and transparency in a Zoom forum. Rep. Katherine Clark hosts a Facebook Live with Rep. Andy Levin on protecting workers' rights during the pandemic.   THE NEW NORM? Sales of medical self-exam kits and diagnostic software are surging among people opting to monitor their vital signs at home during the pandemic. How are medical professionals adjusting to the new norm? The health care system is rapidly changing during the pandemic, and emerging technologies will continue to drive change. Future Pulse spotlights the politics, policies, and technologies driving important change on voters' most personal issue: their health. SUBSCRIBE NOW.     THE LATEST NUMBERS – “Massachusetts reports 8 new coronavirus deaths, 168 new COVID cases on Tuesday,” by Tanner Stening, MassLive.com: “State health officials announced another eight coronavirus deaths on Tuesday, bringing the statewide death count to 8,933 since the beginning of the pandemic. Officials also confirmed another 168 cases of COVID-19, for a total now of at least 121,214 cases across the state.” DATELINE BEACON HILL – “State's unemployment fund operating in red,” by Christian M. Wade, Eagle-Tribune: “A state fund that pays for jobless benefits will be more than $2.4 billion in the hole by the end of the year, and that will likely mean higher taxes next year for business owners. The Unemployment Trust Fund, which totaled $1.1 billion last year, had a deficit of nearly $750 million as of July 31 amid a tsunami of unemployment claims tied to the coronavirus pandemic, according to the latest data by the state Executive Office of Labor and Workforce Development.” – “‘I want this thing to land’: Rep. Russell Holmes is ready to start screaming again over police reform bill,” by Christopher Gavin, Boston.com: “While the annual emptying of the Massachusetts State House amid the hazy, waning days of summer has left the capitol halls quiet, Mattapan state Rep. Russell Holmes expects to make noise this week. Holmes, the ardent advocate for the pending police accountability legislation who pushed to lock down a policy by August, told Boston.com recently he intends to push just as hard to get a bill out of conference committee and onto Gov. Charlie Baker’s desk once lawmakers return after Labor Day.” – “Baker Administration Inflates Its Claim Of Spending With Minority Businesses,” by Paul Singer, GBH News: “Each year, Massachusetts sets a goal for how much money state agencies should spend with non-white vendors, and Baker has increased that goal more than once since taking office in 2015. In 2018, the goal was 7% of each agency's budget; for 2019 Baker raised the goal to 8%. And each year of his tenure, the state has issued a report showing it has exceeded the goal by tens of millions of dollars." – “Car manufacturers pool $25m to fight auto repair ballot question,” by Shira Schoenberg, CommonWealth Magazine: “The national automotive industry is ponying up huge sums of money to defeat a question on the Massachusetts ballot that would give independent auto repair shops the right to access more information about the cars they are repairing. As of August 30, car manufacturers had contributed $25 million to the Coalition for Safe and Secure Data, a ballot committee formed to defeat Question 1 on the November ballot.” – “Massachusetts' protections weren't enough to stop evictions,” by Noemi Arellano-Summer, Anoushka Dalmia, Sophia Brown and Nick McCool, The Howard Center for Investigative Journalism: “Massachusetts had some of the nation's strongest tenant protections during the federal CARES Act's eviction moratorium, with thousands of residential evictions suspended in state court and a block on the filing of most new cases. But a two-month investigation of the federal and state moratoriums by Boston University journalism students, in collaboration with the Howard Center for Investigative Journalism, found holes in safeguards against evictions for Massachusetts tenants emerged soon after the laws took effect.” – “Is that apartment real? Healey warns of virtual rental scams,” by Tim Logan, Boston Globe: “With apartment searches going more online and virtual during the COVID-19 pandemic, real estate agents and Massachusetts’ top law enforcement official are warning would-be renters about a costly bait-and-switch. Attorney General Maura Healey said her office is seeing a surge in scams where people advertise apartments they don’t own and rip off a month’s worth of rent, or more, from tenants who are eager to find a place but wary of touring it in person right now.” – “4 states with green light for Mass. travel don’t meet criteria,” Cape Cod Times: “Rhode Island is still on the list of states from which travelers to Massachusetts are required to quarantine or get a coronavirus test because the state doesn’t meet criteria for unrestricted travel. But four states that also apparently fail to meet the criteria have been removed from the list with no explanation from the administration of Gov. Charlie Baker.” WHAT CITY HALL IS READING – “For Walsh, Wu, the campaign trail looks close,” by Milton J. Valencia, Boston Globe: “They’re not on the campaign trail quite yet, but if you squint, you can see it. In an afternoon news conference Tuesday amid questions about if and when he intends to announce his reelection campaign for mayor, Martin J. Walsh said he is focused on leading the city through the COVID pandemic and ticked off reassuring numbers showing declines in positive cases and the number of deaths.” – “Should Boston have a stronger civilian oversight board for police? City Council is thinking about it,” by Danny McDonald, Boston Globe: “Boston city councilors and local advocates on Tuesday grappled with how to reform the city’s police department, wrestling with the fiscal and public safety implications of police union contracts, and imagining a civilian review board with investigative teeth, including subpoena powers, that exists outside the department.” – “Walsh To Receive Police Reform Report Thursday; Mayor Still Mum On Civilian Review Board,” by Tori Bedford, GBH News: “The Boston Police Task Force will present their recommendations to improve the process of reviewing police misconduct cases to Mayor Marty Walsh on Thursday, the mayor told reporters at a press conference outside City Hall on Tuesday.” FROM THE HUB – “Boston lab Orig3n suspends COVID-19 testing after reporting at least 383 false positives in Massachusetts; Lab director failed to give direction, officials say,” by Jackson Cote, MassLive.com: “Boston-based laboratory Orig3n halted its coronavirus testing in Massachusetts last month after reporting hundreds of false positive test results, with officials chalking up the mistakes to a lack of direction and proper documentation at the lab, among other factors. In early August, the Massachusetts Department of Public Health opened an investigation after it became aware of an unusually high positive rate of COVID-19 tests reported by Orig3n Laboratory.” – “Celtics unveil $25 million, 10-year plan to fight racial injustice,” by Gary Washburn, Boston Globe: “The Celtics, a franchise that drafted the first Black player in the NBA and also hired the first Black coach, made another unprecedented move Tuesday with the announcement of a $25 million commitment over the next 10 years to fight racial injustice and focus on social issues in the Black community of Greater Boston.” – “17 Boston school officials paid $762,000 in settlements,” by Colman M. Herman, CommonWealth Magazine: “In an apparent effort to stave off potential lawsuits for wrongful termination or to just cushion departures, Boston Public School officials shelled out $762,000 over a nearly two-year period for settlement agreements with 17 school employees. The 17 cash settlements were paid to 11 administrators, five teachers, and one librarian. Another 50 settlements did not involve any financial payouts.” – “Parent frustration about schools is rising,” by Bruce Mohl, CommonWealth Magazine: “With less than two weeks until school starts, parents from Somerville and Newton say they have yet to get any details on what classes will look like for their children and whether remote learning will be better than it was when schools suddenly shut down last spring amid COVID-19.” – “Boston police honor officers lost to suicide, vow ‘not to add’ more names to memorial wall,” by Erin Tiernan, Boston Herald: “A soft blue light shrouds the names of 13 officers inscribed on the Boston police suicide memorial wall — a symbolism that Commissioner William Gross said he hopes will raise awareness, end the stigma and ensure ‘we don’t have to add to the wall.’” – “Vaccine CEOs issue safety pledge amid Trump’s quest for pre-election approval,” by Christopher Rowland, The Washington Post: “The chief executives of nine drug companies pledged Tuesday not to seek regulatory approval before the safety and efficacy of their experimental coronavirus vaccines have been established in Phase 3 clinical trials, an extraordinary effort to bolster public faith in a vaccine amid President Trump’s rush to introduce one before Election Day.” YOU'VE GOT MAIL – “Galvin Says State Needs More Than $1 Million For A Smooth November Election,” by Matt Murphy, State House News Service: “With the drama of ballot counting in the Fourth Congressional District behind him, Massachusetts Secretary of State William Galvin called the state's first foray into widespread mail-in voting a ‘great success,’ but said he will need additional funding to ensure that the November election goes off smoothly. THE SENATE SHOWDOWN – “Markey, Kennedy praise each other in Democratic unity livestream,” by Jeremy C. Fox, Boston Globe: “Senator Edward J. Markey and Representative Joseph P. Kennedy III appeared together Tuesday in an online unity event organized by the state’s Democratic party, their first joint appearance since Markey defeated Kennedy in the primary a week ago. The legislators exchanged praise before taking aim at defeating President Trump and other Republicans down the ballot in November.” DAY IN COURT – “Mass. SJC Chief Justice Gants suffers heart attack, expects to resume ‘full duties,’” by Travis Andersen, Boston Globe: “Massachusetts Supreme Judicial Court Chief Justice Ralph D. Gants suffered a heart attack last week, he confirmed Tuesday in a statement. ‘I suffered a heart attack on Friday, September 4,’ Gants said in the statement released by the Mass. Trial Court. ‘I was admitted to the hospital where surgeons inserted 2 stents in the occluded artery, and I expect to be discharged soon. I also expect that I will be able to resume full duties, albeit initially on a limited basis.’” – “Middlesex DA releases more than 400 pages of records on 2011 Eurie Stamps shooting,” by John Hilliard, Boston Globe: “The Middlesex district attorney’s office has released more than 400 pages of records associated with the shooting of Eurie Stamps Sr. by Framingham police in 2011. The release of records follows calls from advocates who said they are demanding justice in Stamps’ shooting.” WARREN REPORT – “Virtual New Yorker Festival Will Host Chris Rock and Elizabeth Warren,” by Sarah Bahr, The New York Times: “A little under a month before Americans cast their ballots, they can be a fly on the wall for a conversation between Senator Elizabeth Warren and Representative Alexandria Ocasio-Cortez. The Democratic lawmakers will be interviewed together by The New Yorker’s Andrew Marantz as part of the 21st New Yorker Festival, which will, for the first time, be a mostly virtual affair.” IT'S NOT EASY BEING GREEN – “Machine Gun Range Proposal Has Environmentalists Up In Arms,” by Eve Zuckoff, GBH News: “On a tree-lined street in south Sandwich, everything is quiet. Sprinklers, birds, and the occasional landscaping truck are all that make a noise. But when physician and retired Air Force colonel Jane Ward walks through the neighborhood, she hears the quiet before the storm. Less than a mile away, the Army National Guard is planning to build Massachusetts’ first and only machine gun range.” – “Attleboro Considering Comprehensive Environmental Bill To Curb Plastic And Other Pollutants,” by Hannah Chanatry, WBUR: “The mayor of Attleboro is filing an omnibus-style environmental policy with the goal of curbing plastic use and other pollutants in the city. The ‘Environmental Protection and Prevention’ ordinance would ban the sale of eight different products.” ABOVE THE FOLD — Herald: “Who's that unmasked man?" "RENTERS RULE,” — Globe: “Celtics commit $25m to boost Black community," "Vaccine test halted over bad reaction.” THE LOCAL ANGLE – “Worcester councilors eye permanent outdoor dining program, if it doesn’t squeeze parking space,” by Nick Kotsopoulos, Telegram & Gazette: “City councilors Tuesday night welcomed the city administration’s efforts to expand outdoor dining options at restaurants on a permanent basis, but they also urged caution so it doesn’t hurt the quality of life in nearby neighborhoods.” – “UTEC hires law firm to probe racism, sexism allegations,” by Alana Melanson, The Lowell Sun: “UTEC, one of the city and state’s best-known nonprofit organizations, has hired a Boston law firm to look into racism, sexism and other allegations set forth in a social media campaign by former employees. According to UTEC board of directors Chairman Scott Mellen, the board has hired attorneys from Todd & Weld LLP to interview the former employees and current staff.” TRANSITIONS – Ava Callender Concepcion joins Waterville Consulting as VP of the firm’s community relations practice. She previously worked as director of government affairs and external partnerships in Suffolk County District Attorney Rachael Rollins’ office and is a state Sen. William Brownsberger alum. HAPPY BIRTHDAY – to Michael Greenwald, managing director at Tiedemann Constantia and director at Tiedemann Advisors, who is 37; Andrew Crane, Jason Denoncourt and Daniel Pipes, who is 71. NEW EPISODE: Inside a $6 billion fundraising machine – On this week’s POLITICO Women Rule podcast, ActBlue Executive Director Erin Hill talks about how the tech platform has raised more than $6 billion since 2004 — including around $3 billion in the 2020 cycle alone. Hill also weighs in on how small-dollar donors are changing politics, how the pandemic is changing small-dollar donors, and what all of this could mean for the future of politics. Link. Want to make an impact? POLITICO Massachusetts has a variety of solutions available for partners looking to reach and activate the most influential people in the Bay State. Have a petition you want signed? A cause you’re promoting? Seeking to increase brand awareness among this key audience? Share your message with our influential readers to foster engagement and drive action. Contact Jesse Shapiro to find out how: jshapiro@politico.com.   BEIJING IS WATCHING, ARE YOU? China has long been a nation of involved and cynical election-watchers, at least when it comes to American presidential campaigns. As the United States races toward Election Day, how do Chinese citizens believe each candidate will affect relations between the two nations? Join the conversation and gain expert insight from informed and influential voices in government, business, law, and tech. China Watcher is as much of a platform as it is a newsletter. Subscribe today.       Follow us on Twitter Stephanie Murray @StephMurr_Jour   Subscribe to the POLITICO Playbook family Playbook  |  Playbook PM  |  California Playbook  |  Florida Playbook  |  Illinois Playbook  |  Massachusetts Playbook  |  New Jersey Playbook  |  New York Playbook  |  Brussels Playbook  |  London Playbook View all our politics and policy newsletters FOLLOW US

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