Home 5 Clinical Diagnostics Insider 5 Diagnostics Pipeline: Startup Women’s Health Lab Receives $4M in Federal Grants

Diagnostics Pipeline: Startup Women’s Health Lab Receives $4M in Federal Grants

by | Jun 27, 2024 | Clinical Diagnostics Insider, FDA-dtet

The grants, which include $3 million from the NIH and $1 million from the NSF, will help the company develop point-of-care tests

Nanopath Inc., a startup laboratory focused on women’s health, has received $4 million in grants from the National Institutes of Health (NIH) and the National Science Foundation (NSF). Based in Cambridge, MA, Nanopath received the funding “to support continued research and development of the company’s point-of-care diagnostic platform for pelvic and gynecologic infections,” the company said in a statement.1

The funding was comprised of a $3 million grant from the NIH and $1 million from the NSF. The grants were obtained via the Small Business Innovation Research (SBIR) Program, a competitive initiative aimed at encouraging technological innovations developed by small businesses. 

Nanopath said the grants bring the total funding for the startup to more than $15 million.1 The company, which was founded in 2019, received a $10 million round of funding in 2022 from a group of investors that includes Norwest Venture Partners, SV Health Investors, and GingerBread Capital.2 The company’s founders, chief executive officer Amogha Tadimety and chief technology officer Alison Burklund, did not respond to emails or a phone call seeking comment.

The company claims it can perform point-of-care molecular-based testing to identify strains of DNA and RNA without the use of any amplification technology and that results can be obtained in as little as 15 minutes.3

Bruce Carlson, publisher of the Eye on IVD Newsletter, noted that time is often of the essence when it comes to women’s healthcare and testing.

“I can say a key need in the area is [having test results to discuss with your doctor],” Carlson says. “That means point of care, and that means fast results—we usually say 30 minutes is the most someone can be in a waiting room. That way doctor consultation can come along with the result, rather than a phone call later, often made by staff.”

However, it can take millions of dollars to develop such tests, which is likely why Nanopath received such a significant grant, Carlson says.

Additionally, the demand for testing focused on women’s health needs is currently underserved, according to Carlson and other industry observers.

“Women’s health as a broad field has been under-invested in for generations. I think there’s a ton of need there,” says Sachin Jain, MD, chief executive officer of SCAN Health Plan, a Medicare Advantage insurer based in California. Last year, SCAN launched an insurance product specifically focused on the needs of older women, an initiative that required Jain and his team to take a closer look at the testing available to women.

However, the tide may be turning.

Last year, the White House, led by First Lady Jill Biden, announced an initiative to “fundamentally change how our country approaches and funds research on women’s health.” The announcement of the initiative also noted that there are “big gaps” in researching diseases and conditions that only affect women, such as endometriosis, as well as maladies such as Alzheimer’s disease, which impacts women disproportionately to men, and heart disease, which impacts women differently than men.4

Multimillion state grant for City of Hope lab

In other funding news, City of Hope Medical Center, based just east of Los Angeles, received a $5.4 million grant from the California Institute for Regenerative Medicine (CIRM) to build a stem cell research laboratory on the hospital grounds. The facility will be used to produce organoids—tiny but workable versions of human tissue-based organs for research—with a particular emphasis on creating both healthy and cancerous versions of brain, heart, and breast tissue that will be used by other medical researchers in the region. It will also be used to further stem cell research in medically underserved communities.5

“Our new laboratory will expand access to state-of-the-art disease models to researchers at City of Hope and our neighboring institutions, enabling them to pursue impactful scientific questions and to accelerate innovation in stem cell therapies,” said Nadia Carlesso, MD, PhD, City of Hope’s chair of stem cell biology and regenerative medicine, in a statement. “This will accelerate research in regenerative medicine, benefiting patients and researchers throughout California. We also aim to plant the seed for future careers in regenerative medicine by educating students about the field.”5

In written replies to questions from Clinical Diagnostics Insider, Carlesso added that the lab will be about 350 square feet in size and will open by December 2025, if not sooner. Its primary focus will be on creating brain organoids to investigate neuroinflammation, chemo-brain, and brain cancer responses to therapies; breast organoids to address cancer predispositions and drug factors; and cardiac three-dimensional modeling to assess the cardiotoxicity of cancer drugs, especially in populations with higher risks of heart disease and related ailments.

“It is likely and expected that in the long term this [lab] will develop LDTs [lab-developed tests] that can be used to guide cancer therapies and approaches to protect normal cells during cancer therapies,” Carlesso wrote.


    1. https://www.prnewswire.com/news-releases/nanopath-receives-4-million-in-grants-from-national-institutes-of-health-and-national-science-foundation-302150413.html
    2. https://www.prnewswire.com/news-releases/nanopath-secures-10-million-in-series-a-funding-to-develop-and-commercialize-point-of-care-diagnostics-for-womens-health-301602364.html
    3. https://techcrunch.com/2022/08/10/nanopath-is-looking-to-drastically-change-medical-diagnostics/
    4. https://www.whitehouse.gov/white-house-initiative-on-womens-health-research/
    5. https://www.businesswire.com/news/home/20240520952331/en/


Key recent FDA approvals of laboratory-related platforms, IVD devices, and over-the-counter tests and products include:

Company Name Approval Date What Was Approved Complexity
Luminex Corporation June 13, 2024 LIAISON PLEX® Yeast Blood Culture Assay Moderate
Smilelab Co., Ltd. June 11, 2024 Two approvals for the Pregable ovulation and pregnancy test kit Waived
Siemens Healthcare Diagnostics June 11, 2024 Three approvals for the ADVIA chemistry system Moderate
Abbott June 7, 2024 Six approvals for a quantitative assay with fecal extraction for Abbott Architect instruments High
Beckman Coulter June 7, 2024 Five approvals for the Beckman Coulter AU480 quantitative assay with fecal extraction High
Sysmex June 7, 2024 Two approvals for an automated blood coagulation analyzer Moderate
Serenity Healthcare Corp. June 4, 2024 Two approvals for the KEYSMED Ovulation Test Strip & Pregnancy Test Strip Kit Waived
W.H.P.M., Inc. June 4, 2024 30 approvals for the EZ CLICK Multi-Drug Screen Test Cup Waived
Horiba ABX June 3, 2024 12 approvals for the Sas Yumizen H2500 testing platform. Moderate
Siemens Healthcare Diagnostics May 31, 2024 The Atellica® CI analyzer for prostate-specific antigen Moderate
Siemens Healthcare Diagnostics May 29, 2024 Three approvals for analyzers performing thyroid stimulating hormone testing Moderate
Beckman Coulter May 29, 2024 Two approvals for the AU480 chemistry analyzer Moderate
American Screening Corp. May 29, 2024 30 approvals for drug test dip cards Moderate/Waived
CLIAwaived, Inc. May 29, 2024 33 approvals for multi-panel drug test cups and cards Waived
BTNX, Inc. May 29, 2024 14 approvals for urine drug test cups Waived
Co-Innovation Biotech May 24, 2024 Two approvals for a rapid fentanyl urine test strip and dipcard Waived
DiaSorin May 20 and 24, 2024 Approvals of the LIAISON® XL Analyzer platform for parvovirus B19 antibodies and fecal sample matrix Moderate/High
American Screening Corp. May 24 and 23, 2024 15 approvals for a multi-panel urine drug test cup Waived
Healgen Scientific LLC May 20, 2024 Six approvals for a rapid fentanyl test Waived
Source: FDA CLIA and OTC databases

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