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A former Grail exec and the president of the Chan Zuckerberg Biohub are developing a blood test to help expectant mothers understand the chances of pregnancy complications

mirvie
Mirvie cofounder Maneesh Jain (right) with one of Mirvie's scientists. Mirvie

  • Mirvie is developing a blood test for expectant mothers to predict pregnancy complications.
  • It was founded in 2018 by former Grail exec Maneesh Jain and Chan Zuckerberg Biohub president Dr. Stephen Quake.
  • The company is conducting clinical trials and plans to apply for approval for its liquid biopsy tests.

After experiencing complications during their own children's births, Maneesh Jain and Dr. Stephen Quake both committed the rest of their professional careers to helping other parents avoid unexpected conditions during pregnancy and, hopefully, any stay in the neonatal intensive care unit.

Together, they started Mirvie in 2018. Quake had been working at the Chan Zuckerberg Biohub, a research unit funded by the Facebook CEO and his wife Priscilla Chan, where he developed noninvasive prenatal tests to detect genetic mutations.

Jain previously founded a cancer detection startup before becoming president of Butterfly, an ultrasound and imaging company. His last company prior to founding Mirvie specialized in creating plasma-based tests for cancer detection, and sold to Grail in 2017.

With Mirvie, Quake and Jain are attempting to apply liquid biopsy technology more commonly found in oncology centers to pregnancy, a more common but significantly less funded area of research, according to Jain. Similar to how the success of the mRNA COVID-19 vaccines has led to research for other infectious diseases, Jain thinks Mirvie benefits from the success of noninvasive blood tests in cancer research after recovering from some false starts in the industry and a reputational hit in the Theranos implosion.

Mirvie also marks one of the first times a women's health startup has tapped into cutting-edge blood testing. Typically, women's health startups, which largely focus on just pregnancy and fertility, consist mainly of tracking apps or concierge services. Although still in preliminary clinical trials, Mirvie could have the potential to shift investors' understanding of what a women's health startup could look like.

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"Women's health, and particularly pregnancy, where there's so much effort and money on this technology that you apply to cancer, and yet, women's health has been left behind," Jain told Insider. "When we first started, I was like, wow, this field is about two to three decades behind."

Mirvie wants to detect potential complications using RNA

Mirvie is actively conducting a trial with thousands of patients to gather further proof of the test's efficacy, Jain said. Its test wants to detect potential complications by reading the RNA messages that travel from the mother's placenta to the baby.

The RNA in the placenta communicates how the fetus develops and could indicate complications like preterm birth or gestational diabetes prior to the onset of symptoms, Jain said. Mirvie's test would conduct the analysis using a small blood sample from the mother and look for indicators of conditions like preterm birth, preeclampsia, and gestational diabetes. The tests are currently used near the end of the second trimester, Jain said.

A peer-reviewed study in UpToDate from Dr. S Ananth Karumanchi, Dr. Kee-Hak Lim, and Dr. Phyllis August in July 2020 found that a mother's chance of developing severe preeclampsia could be detected through a specific protein marker that was carried in some novel RNA messengers. The authors emphasized that this was a preliminary finding, and more research was needed to understand how the two components were related.

The startup's clinical trial is currently underway and Jain expects the results to be available later this year. Pending on what the results show, Mirvie plans to apply for regulatory approval for its tests.

Even without an approved product, Mirvie has raised roughly $30 million from Khosla Ventures and Mayfield. Jain said that the funds have helped him hire his team, which is currently at about 20 people, and work through the expensive trial phase of the early-stage company.

"You can solve the hard science problems, but you want to spend as much time on the business model and having conversations and bringing stakeholders together," Mayfield general partner Ursheet Parikh told Insider. Mayfield led Mirvie's Series A funding round in April 2020. 

Currently, Mirvie is planning on working with insurance companies to cover the costs of its tests to help broaden access beyond patients who can afford to pay out of pocket. However, it will have to wait for the trial results later this year, and FDA approval following that, before it is able to move forward with that plan.

"In the case of preeclampsia, costs really can add up pretty quickly," Jain said. "I think it'll make financial sense for payors to cover this."

Women's Health Biotech Startups

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