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Washington state lawmakers seek to ban at-home rape test kits after AG takes aim at startup

Leda Health co-founders Madison Campbell, CEO (left), and Liesel Vaidya, chief technology officer. (Leda Health Photo)

Washington state lawmakers are considering a bill to ban over-the-counter sexual assault test kits that critics say give false hope to victims.

The proposed law would affect Leda Health, a New York-based startup that says its “early evidence kits” offer an alternative to in-person evidence collection for rape victims.

Leda has already stopped marketing in Washington state, said Madison Campbell, CEO and co-founder of the 3-year-old startup. More than a dozen state attorney generals issued cease and desist orders to Leda Health, including Washington State Attorney General Bob Ferguson.

“Leda’s Early Evidence Kits are ineligible for testing by the Washington State Crime Lab as they are self-administered, and face numerous barriers to admission as evidence, including on the basis of potential cross-contamination, spoliation, and validity,” said Ferguson in a Oct. 31 letter to Leda Health that said the company violated the state’s consumer protection act.

Leda’s kit instructs users to swab DNA samples at home after a sexual assault and includes a care team for live virtual support. The samples are sent to private labs. Leda also provides online access to plan B options, along with test kits for HIV and other sexually transmitted infections.

Campbell said she is a survivor of sexual assault and did not seek professional evidence collection from a medical provider. She knew about the option, but after the trauma of the assault did not feel like being touched or going in for an exam.

Campbell said she is not alone. There are many rape victims who want an alternative to an in-person exam, she said.

“Survivors should have the ability to collect evidence in the comfort of their own home, talk to a nurse in the comfort of their own home, get emergency contraceptive, get STI testing, the whole lot,” said Campbell.

The CEO said she was surprised by the controversy surrounding her company. She was in Olympia, Wash., this week testifying against the bill, HB 1564.

One critique of over-the-counter kits is that a defense attorney could claim that a victim inserted DNA of a suspect onto swabs, The University of Washington Daily reported last year.

Leda tells patients that its product does not replace in-person care, said Campbell. The company also said, in a statement provided to Geekwire, that “just because the process differs from the way the evidence has historically gotten to law enforcement doesn’t mean the evidence is inadmissible, tainted, or not valuable.”

Leda previously contracted with a sorority affiliated with the UW, and sells its kits along with a lockbox to groups as a subscription service. It does not market to individuals.

Shannon Bailie, director of the LiveWell Center for Advocacy, Training and Health Promotion at the UW, said UW Medicine and hospitals throughout much of the country provide access to specially trained sexual assault nurse examiners (SANEs).

SANEs provide free wraparound support and evidence collection, including head-to-toe exams, collection of photographic evidence, swabs at multiple locations on the body, as well urine and blood samples that can also be used in toxicology testing. In Washington, survivors can track the status of their kits online.

“We are concerned that at-home kits are taking advantage of individuals in moments of crisis and attempting to profit off of selling something that has yet to be proven admissible or effective,” said Bailie.

Data from SANE-collected kits are also eligible for uploading into the federal CODIS (Combined DNA Index System) database, which contains DNA data from convicted offenders and arrestees of certain crimes. Leda does not have access to CODIS, according to the company.

SANEs “are trained to make sure that evidence is collected in a way that can get to prosecution. They will provide you with legal support so that you can get a real pathway to justice,” said Gina Mossbrucker (R-Goldendale), a sponsor of the legislation. She spoke in front of the House Community Safety, Justice and Reentry committee Tuesday about the bill, which is up for a vote in the committee on Feb. 16.

“We are concerned that at-home kits are taking advantage of individuals in moments of crisis and attempting to profit off of selling something that has yet to be proven admissible or effective.”

Leah Griffin, a survival of sexual assault and an advocate who fought for laws to clear Washington’s state’s rape kit backlog, testified that the problem Leda is trying to solve is “real.” Victims need more access to sexual assault nurse examiners, she said.

While she welcomed Leda’s other services, Griffin said the next attorney general may provide less scrutiny of in-home sexual assault tests and asked the committee to pass the bill.

Leda was founded in 2019 as the MeToo Kits Company and raised $9.4 million from investors including Wildcat Capital Management, Acme Venture Capital, 7Wire Ventures, NYStateFund, Backstage Capital and former Reddit CEO Yishan Wong. Campbell and Leda co-founder Liesel Vaidya were named to the Forbes 30 under 30 list in healthcare.

Other companies have sold similar kits, but Leda said it is now the only company offering at-home services. Leda’s kits are also being used in Ukraine to support justice for victims of sexual violence.

In testimony before the committee, Campbell said her company consulted with health and judicial experts throughout its development and that it had survivors’ interests in mind. The company is willing to evolve with input, she said, and asked the committee to reconsider the issue next year after more discussion.

“I think there’s opportunity still for us to work together,” said Campbell.

Meanwhile, some rural areas are using telehealth to access sexual assault nurse examiners, who can guide health providers at clinics or hospitals in proper procedures. The Massachusetts Department of Public Health launched a center to provide specialized support to on-site health workers performing sexual assault exams, funded by the U.S. Department of Justice’s Office for Victims of Crime.

In California’s Monterey County, officials went further during COVID-19 and instituted a controversial temporary system that enabled victims to collect DNA data at home by themselves, using a kit provided by another company, Preserve Group. At the time, the system raised questions about the quality of evidence and chain of custody among crime experts.

Heidi Zinzow, a professor of psychology at Clemson University, published a study cited by Leda suggesting that only about 21% of rape victims seek medical services. The data were collected in 2006 and are dated, noted Zinzow, but even now people need to know more about available services.

“Policy and programmatic initiatives would be better directed toward encouraging survivors to seek formal services in a timely fashion, including medical care and forensic exams,” said Zinzow. “We need more education on available resources, how confidentiality is protected, where resources can be accessed, and what takes place during encounters with providers.”

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