Prolacta Bioscience Develops World's First Test to Directly Detect Bacteria and Viruses, Including SARS-CoV-2, in Donor Breast Milk

All Donor Human Milk Used in Prolacta's Nutritional Products Is Now Directly Tested, Setting the Highest Standard in the Human Milk Industry

News provided by

Prolacta Bioscience

Oct 29, 2021, 10:03 ET

DUARTE, Calif., Oct. 29, 2021 /PRNewswire/ -- Prolacta Bioscience®, the world's leading hospital provider of 100% human milk-based nutritional products, announced today that it has developed the first nucleic acid amplification test (NAAT) capable of directly detecting the presence of infectious disease-causing pathogens in donated breast milk, including bacteria and viruses such as SARS-CoV-2, the virus that causes COVID-19. Prolacta is the first and only company in the human milk industry to apply NAAT to all donor milk received through its milk banks, leading the industry with unmatched quality, safety, and bioactivity.

Ensuring Safety Against Emerging Threats in Human Milk-Based Products with Nucleic Acid Amplification Test (NAAT)

This advance in donor milk testing addresses one of the biggest concerns for the human milk-banking industry: the potential for a milk donor to contract a pathogen, which could be passed along undetected in her breast milk, after the initial or subsequent blood screenings. The current human milk-banking industry practice is to test milk donors at various intervals for bloodborne pathogens and infectious diseases. Because donors are not tested each time they donate milk, a donor could unknowingly contract an infectious virus or bacteria after her initial blood test or between her subsequent blood tests and donate milk that could be affected.

Because NAAT directly tests the milk itself, Prolacta can ensure that both the donor (through the blood screening) and the donated milk are tested for infectious disease-causing pathogens, reducing the risk of contaminated breast milk ending up in the neonatal intensive care unit (NICU).

"Elevating the safety of donor milk to include real-time direct testing for viruses and bacteria is a transformative advancement in the human milk industry and adds another critical layer of safety before pasteurization," said Scott Elster, president and CEO of Prolacta. "We have long employed a `belts and suspenders' approach to quality and safety. The infants fed our nutritional products are extremely fragile, so we take all precautions possible to ensure their safety. Incorporating SARS-CoV-2 testing into our NAAT technology is part of our ongoing commitment to maintain the industry's highest quality and safety standards while also ensuring that our products contain the highest bioactivity possible to benefit the health, development, and immunity of the infants we serve."

About Prolacta's NAAT Protocol
Prolacta's NAAT protocol for its human milk-based nutritional products screens all incoming donated breast milk directly, rather than relying on periodic donor blood tests or later bulk milk testing for viral DNA markers. Prolacta initiated NAAT on all incoming donor milk in 2017. The company has since expanded the platform to test for 10 disease-causing pathogens. Adding real-time NAAT for the presence of SARS-CoV-2 (COVID-19 virus), Mycobacterium tuberculosis (TB bacteria), Zika virus (ZIKV), T. pallidum (bacteria that causes syphilis), human immunodeficiency virus type 1 and 2 (HIV-1 and HIV-2), human T-lymphotropic virus type I and II (HTLV-I and HTLV-II), and hepatitis B and C further ensures the safety of Prolacta's human milk-based nutritional products and establishes the highest level of protection in the human milk-banking industry.

2017: Prolacta begins using NAAT protocol for directly testing all incoming donated human breast milk for:

Hepatitis C
HIV-1 and HIV-2
HTLV-I and HTLV-II
T. pallidum
ZIKV

2019: Added Mycobacterium tuberculosis testing to meet request from New York state tissue bank licensing
2020: Added SARS-CoV-2 testing for increased precaution against this latest threat

The NAAT platform can also be expanded to test for future viruses or bacteria to protect against emerging threats. While all of Prolacta's products are made from human milk tested using the latest NAAT process, shipment of the various products in the portfolio varies by market. Currently, 99% of products shipped, including all in the U.S., have been produced using human milk tested for SARS-CoV-2.

Prolacta is the only company in the human milk industry that has developed, validated, and implemented more than 20 tests for the screening of donated milk to ensure quality and safety, including screening for drugs of abuse, such as opiates and other substances, as well as adulteration or dilution. Prolacta is also the first in the human milk industry to test donated breast milk for nicotine and marijuana. Prolacta's products made with donated breast milk are also tested for aerobic bacterial count, B. cereus, E. coli, Salmonella, Pseudomonas, S. aureus, coliforms, yeast, and mold. Prolacta is currently testing for B. cereus emetic toxins, which are not inactivated by heat and can be deadly to premature infants if present in human milk. All donors who provide breast milk to Prolacta will continue to have qualifying blood and screening tests and subsequent blood tests and health screenings every six months.

In addition to directly testing the milk, Prolacta's fortifiers are vat pasteurized and manufactured under the U.S. Food and Drug Administration's Pasteurized Milk Ordinance. This ensures pathogen inactivation and the highest level of safety while retaining as much of the natural bioactivity of the milk as possible.¹ Prolacta's vat pasteurized fortifiers retain higher bioactivity than fortifiers processed using retort sterilization and ultra-high-temperature (UHT) processing,^2,3 benefiting infants' immunity, development, and overall health.¹

From donor to recipient, the entire life cycle of Prolacta's human milk-based nutritional products follows the highest quality and safety standards, including a donor medical review, blood testing and a DNA sample, DNA matching, raw milk testing, and vat pasteurization and processing. These industry-leading procedures are modeled after those used in the human plasma and blood industries. Hospitals choose Prolacta's products, which are processed in a pharmaceutical-grade facility, to protect the health and well-being of their most fragile patients. For more information on Prolacta's industry-leading quality and safety standards, visit Prolacta.com/safety.

About Prolacta Bioscience
Prolacta Bioscience® Inc. is a privately held global life sciences company dedicated to Advancing the Science of Human Milk® to improve the health of premature and critically ill infants. Prolacta's 100% human milk-based nutritional products have been evaluated in more than 20 clinical trials published in peer-reviewed journals. More than 70,000 premature infants have benefited from Prolacta's nutritional products worldwide to date.⁴ Established in 1999, Prolacta is the world's leading provider of human milk-based nutritional products for hospital use and is also exploring the therapeutic potential of human milk across a wide spectrum of human diseases. Prolacta maintains the industry's strictest quality and safety standards for screening, testing, and processing human donor milk. Operating the world's first pharmaceutical-grade human milk processing facilities, Prolacta uses vat pasteurization and a patented FDA-reviewed manufacturing process to ensure pathogen inactivation while protecting the nutritional composition and bioactivity of its human milk-based products. Prolacta is a global company with headquarters in Duarte, California, and can be found online at www.prolacta.com, on Twitter, Instagram, Facebook, and LinkedIn.

Media Contact
Loren Kosmont
[email protected]
310-721-9444

References

Gila-Diaz A, Arribas SM, Algara A, Martín-Cabrejas MA, López de Pablo ÁL, Sáenz de Pipaón M, Ramiro-Cortijo D. A review of bioactive factors in human breastmilk: a focus on prematurity. Nutrients. 2019;11(6):1307. doi:10.3390/nu11061307
Lima HK, Wagner-Gillespie M, Perrin MT, Fogleman AD. Bacteria and bioactivity in Holder pasteurized and shelf-stable human milk products. Curr Dev Nutr. 2017;1(8):e001438. doi:10.3945/cdn.117.001438
Meredith-Dennis L, Xu G, Goonatilleke E, Lebrilla CB, Underwood MA, Smilowitz JT. Composition and variation of macronutrients, immune proteins, and human milk oligosaccharides in human milk from nonprofit and commercial milk banks. J Hum Lact. 2018;34(1):120-129. doi:10.1177/0890334417710635
Data on file; Estimated number of premature infants fed Prolacta's products from January 2007 to August 2020.