SAN DIEGO--(BUSINESS WIRE), January 9, 2023 --Juno Diagnostics™ (JunoDx™), a company focused on bringing vital health information to patients by improving access, affordability, and transparency, today announced the expansion of its product portfolio with the launch of Juno Hazel™ Plus, a non-invasive prenatal screening (NIPS, also known as NIPT) solution enabled through finger-prick amounts of blood, and the creation of an Early Access Program (EAP). Similar to the Juno Hazel™ screening test, Juno Hazel™ Plus leverages JunoDx’s proprietary Sample Collection Kit to improve early access to high-quality genetic testing without the high costs, long lead times, and phlebotomy requirements of venous-based NIPS.

Juno Hazel™ Plus offers a comprehensive prenatal screening solution by screening for common chromosomal trisomies, sex chromosome aneuploidies, and fetal sex. The laboratory-developed test has been evaluated for clinical performance in multiple studies inclusive of >1,600 total venous and capillary samples. Prenatal aneuploidy screening through Juno Hazel™ Plus offers an expected >99% sensitivity and >99.9% specificity for Trisomy 21 (Down syndrome), Trisomy 18 (Edwards syndrome), Trisomy 13 (Patau syndrome), and an expected >95% sensitivity for sex chromosome aneuploidies including Monosomy X (Turner syndrome), XXY syndrome (Klinefelter syndrome), Triple X syndrome, and XYY syndrome (Jacobs syndrome).  

“The expansion of our product portfolio with the launch of our second NIPS test, Juno Hazel™ Plus, represents a significant milestone for JunoDx™. Combined with the creation of our Early Access Program, this launch brings us closer to providing global access to highly accurate, affordable prenatal care for all pregnant people,” said Dirk van den Boom, Founder and Chief Executive Officer of JunoDx™. “We are excited to expand our commercial reach and deliver on the JunoDx mission through the infinite opportunities afforded by our novel approach to blood-based testing.”

The Company’s EAP offers physicians, genetic counselors, and other providers exclusive means of accessing JunoDx’s growing suite of innovative products and services prior to public privy. Through Juno Hazel™, Juno Hazel™ Plus, and associated services such as curated educational resources and personalized genetic counseling support via telehealth, JunoDx™ aims to equitably facilitate a higher level of prenatal care for all.

Todd Whitson, Executive Vice President of Global Business Development and Commercial Operations, added, “The team at Juno has spent the last decade pioneering the development and commercialization of non-invasive prenatal screening, and we are thrilled to bring another innovation to the NIPS market with Juno Hazel™ Plus.  To ensure every pregnancy has the opportunity to benefit from our product portfolio, the time is now to create and launch a formalized Early Access Program. Our EAP will allow us to work with select providers on introducing the Hazel products while also ensuring we are solving the most important screening access challenges faced by pregnant people everywhere.”

About the Juno Hazel™ and Hazel™ Plus Screens

The Juno Hazel™ and Hazel™ Plus screens are paired with the JunoDx Sample Collection Kit, a proprietary product enabling immediate generation of blood plasma for subsequent laboratory testing from only a few drops of blood. This powerful combination of ultra-low volume testing from samples collected at home reduces overall test cost, increases broad screening access, and improves the NIPS experience for patients and providers alike. The JunoDx approach eliminates the need for traditional phlebotomy, a significant barrier to test access in many clinical settings. Juno Hazel™ screens for common chromosomal variations (trisomy 21, 18, and 13) and fetal sex. Juno Hazel™ Plus expands aneuploidy risk assessment beyond that offered by Juno Hazel™, including screening for sex chromosome aneuploidies such as Monosomy X (Turner syndrome), XXY syndrome (Klinefelter syndrome), Triple X syndrome, and XYY syndrome (Jacobs syndrome), in addition to common aneuploidy screening and fetal sex testing.

Juno Hazel™ Plus offers a comprehensive prenatal screening solution by screening for common chromosomal trisomies, sex chromosome aneuploidies, and fetal sex

About Juno Diagnostics™

Juno Diagnostics is a category-defining health company bringing vital prenatal health information to patients by combining accessibility, affordability, and transparency. The Company has developed a proprietary Sample Collection Kit and Device to facilitate capillary blood-based testing. Its lead product, the Juno Hazel™ screen, is a non-invasive prenatal screening (NIPS) test that utilizes the proprietary Sample Collection Kit and improves access to high-quality screening results without the high cost, long lead times, and phlebotomy requirements of venous-based NIPS.

For more information, visit www.junodx.com and engage with us on LinkedIn.

Investor and Media Contact:
Amy Conrad
Juniper Point
amy@juniper-point.com
858-366-3243
January 09, 2023 — Stephanie McClintock