NxGen MDx announces the immediate launch and availability of their COVID-19 Test

GRAND RAPIDS, Mich., March 23, 2020 — To combat the lack of test availability, NxGen MDx announced today the immediate launch and availability of their COVID-19 Test.

The rise in U.S. cases of COVID-19, a highly contagious and sometimes fatal respiratory illness, has concerned health officials and spurred calls from lawmakers for action to expand testing capacity to slow its spread.

“Like the CDC-built kits, ours will be conducted on QuantStudio qPCR instrumentation and will be able to process 2000 samples per day with tests being resulted in 24-48 hours,” said Dr. Jacqueline Peacock, Director of Laboratory
Operations.

The test will help meet a major U.S. shortfall of diagnostic capabilities that has severely limited the nation’s ability to track the spread of the outbreak.

“COVID-19 is a global challenge and we are committed to providing people on the frontlines of this pandemic with critical tests to help ensure proper care,” said Alan Mack, CEO of NxGen MDx.

To ensure providers can give their patients the most comprehensive diagnostic results, NxGen MDx is also working to validate a 40+ respiratory pathogen panel to identify the cause of respiratory symptoms in a single test. This test is slated for launch in July 2020. 

About NxGen MDx
NxGen MDx LLC is a leading women’s health company delivering highly accurate and
precise genetic testing. NxGen MDx’s history of whole-gene sequencing combined with
advanced technology allows us to provide accessible, high-quality testing options to
families as they plan for the future. NxGen MDx employs state-of-the-art technology,
including rapid molecular diagnostics for infectious disease and genetic screening
technology that examines the entire gene rather than parts of the gene, giving women and
families a comprehensive assessment of their health. NxGen MDx is based in Grand Rapids,
Michigan. To learn more, visit the company’s website at www.nxgenmdx.com.

NxGen MDx announces Urogenital Pathogens Tests with a turnaround of 24 hours

GRAND RAPIDS, Mich., Nov. 6, 2019 — NxGen MDx announced the launch of their Urogenital Pathogens Tests, a group of women’s health tests. The Urogenital Pathogens Tests includes tests for vaginosis, urinary tract infection, and group B streptococcus.

Each year, 10 million doctor visits can be attributed to reoccurring vaginal infections. Of these 10 million visits, 40% of women leave their initial office visit undiagnosed. Hospitalizations related to UTIs alone cost the U.S. hospital system $2.8 billion annually.

“There’s an industry need for faster, better UTI and vaginosis tests. These infections are increasingly resistant to antibiotics, so being able to provide results including antibiotic resistance is crucial to doctors providing their patients with effective prescriptions as soon as possible,” said Alan Mack, CEO of NxGen MDx.

All three tests in the Urogenital Pathogens Tests use real-time PCR technology to offer superior accuracy and a turnaround time of just 24 hours.

The NxGen MDx UTI Test screens for the 17 organisms responsible for 99% of community-acquired urinary tract infections with a sensitivity of >99%, as well as 9 classes of antibiotic resistance to inform treatment decisions.

The NxGen MDx Vaginosis Test screens for a total of 34 organisms involved in vaginosis. This comprehensive tool includes organisms that can cause aerobic vaginosis, bacterial vaginosis, viral infections, and vulvovaginal candidiasis. Assessment of normal vaginal flora, which can be displaced by pathogens, and testing for 9 classes of antibiotic resistance are also included in this panel to provide a complete, actionable result within 24 hours. Group B Strep is included in the NxGen Vaginosis Test and is available as a standalone test.

“As a women’s health company, it made sense for us to transition into offering these tests. Our established sales force allows for easy, quick integration of these tests across the country,” said Mack.

About NxGen MDx
NxGen MDx LLC is a leading women’s health company delivering comprehensive and precise genetic screening that detects genetic diseases or abnormalities to help families make informed decisions and support women’s health needs. NxGen MDx employs state-of-the-art technology, including rapid molecular diagnostics for infectious disease and genetic screening technology that examines the entire gene rather than parts of the gene, giving women and families a comprehensive assessment of their health. NxGen MDx is based in Grand Rapids, Michigan. To learn more, visit the company’s website at www.nxgenmdx.com.

NxGen MDx implements hereditary cancer panel

GRAND RAPIDS, Mich., Oct. 25, 2018 — NxGen MDx announced the creation of the NxGen MDx Hereditary Cancer Panel, which will test for variants in 32 genes known to cause certain forms of hereditary cancer.

Of over 1 million women with a family history of breast/ovarian cancer that meet testing criteria, only 13.8% undergo genetic testing (1). The NxGen MDx Hereditary Cancer Panel was designed to provide an easily available and affordable test to meet patients’ needs. The test includes genes known to impact lifetime risk for breast, ovarian, colon, pancreatic, prostate, uterine, gastric, and melanoma cancers.

In addition to evaluation of the 32 genes for cancer risk variants, patients who order the NxGen MDx Hereditary Cancer Panel will receive a personalized breast cancer risk assessment. This risk assessment is performed even if they are negative for any variants in the 32 genes screened and is based on a combination of their test results, reported family history, and personal health history.

“The addition of an oncology panel is a natural fit for NxGen. We’ve always been best-in-class using whole-gene sequencing, so it just made sense to use our expertise to round out our women’s health focus,” said Alan Mack, CEO of NxGen MDx.

The Hereditary Cancer Panel, like all screening from NxGen MDx, comes combined with genetic counseling to help patients fully understand their results and what they may mean for the future.

1. Childers. C.P., Childers, K.K., Maggard-Gibbons, M., & Macinko, J. (2017, December 1), National estimates of genetic testing in women with a history of breast or ovarian cancer. Journal of Clinical Oncology. 35(34), 3800-3806.

About NxGen MDx
NxGen MDx LLC is a leading women’s health company delivering highly accurate and precise genetic screening that detects genetic diseases or abnormalities and helps families make informed decisions. Unlike other laboratories, NxGen MDx’s technology examines the entire gene rather than parts of the gene, giving families a comprehensive assessment of their true risk. NxGen MDx is based in Grand Rapids, Michigan. To learn more, visit the company’s website at www.nxgenmdx.com.

NxGen MDx implements AMI tagging to track samples, preventing lab errors

Grand Rapids, MI, July 9, 2018 – NxGen MDx announced the development and implementation of a new method of DNA tagging to track samples and prevent laboratory errors. Active molecular identification (AMI) tagging uses synthetic DNA to tag a patient’s sample at the beginning of the testing process.

“Laboratory errors occur in every medical lab across the world. NxGen MDx employs a robust physical tracking system to ensure specimen integrity throughout the testing process; however, it is important for all laboratories to acknowledge that no system is foolproof. AMI tagging provides the ultimate check of a laboratory’s specimen tracking system and ensures that patients receive the most accurate results possible,” said Jonathan Karnes, Vice President of Scientific Operations at NxGen MDx.

AMI tagging repeatedly identifies and connects the initial patient specimen to the final test results, limiting the possibility for human error and sample mix-ups. The synthetic DNA of the AMI tag accompanies the patient’s sample throughout the testing process. NxGen MDx carried out extensive validation studies to ensure that the unique DNA sequences in AMI tags do not affect testing.

About NxGen MDx
NxGen MDx LLC is a leading women’s health company delivering highly accurate and precise genetic screening that detects genetic diseases or abnormalities and helps families make informed decisions. Unlike other laboratories, NxGen MDx’s technology examines the entire gene rather than parts of the gene, giving families a comprehensive assessment of their true risk. NxGen MDx is based in Grand Rapids, Michigan. To learn more, visit the company’s website at www.nxgenmdx.com.

NxGen MDx announces the move of their Non-Invasive Prenatal Test in-house

Grand Rapids, MI, December 2, 2016 – NxGen MDx announced today that it brought its NxGen Informed Prenatal Test in-house.

“By bringing the test in house, we’ve been able to improve customer service through shortened turnaround times and at the same time keep costs down for patients,” says Alan Mack, CEO of NxGen MDx.

A decrease in turnaround times by 25% combined with an increase in test volume has led to more job opportunities at the Grand Rapid headquarters.

The NxGen Informed Prenatal Test uses the illumina NGS platform and can, with the highest degree of accuracy, determine the presence of chromosomal aneuploidies in a developing fetus. The test can be done as early as 10 weeks into the pregnancy and has no limitations in terms of ethnicity, body mass index, assisted reproductive technology, or egg donor cases.

Patients can use the information this test provides to learn more about the risk of non-inherited chromosomal conditions and weigh the benefits and risks of further invasive diagnostic procedures.

About NxGen MDx
NxGen MDx LLC is a leading clinical molecular diagnostics laboratory delivering highly accurate and precise genetic screening to detect genetic diseases or abnormalities to help guide family planning decisions for couples and their healthcare providers. Unlike other laboratories, NxGen MDx’s technology examines the entire gene rather than parts of the gene, giving families a comprehensive assessment of their true risk. NxGen MDx is located in Grand Rapids, Michigan.

The Right Place assists molecular research lab with expansion in Grand Rapids, Michigan

NxGen MDx to invest $2.8 million, creating 37 new high-tech jobs

GRAND RAPIDS, MICH. (12/14/16) – Regional economic development organization The Right Place, Inc., along with its local and state partners in the City of Grand Rapids, today announced the approval of a Michigan Strategic Fund (MSF) incentive that will bring 37 new high-tech, life science jobs and $2.8 million in new investment to Grand Rapids, Michigan over the next three years.

Grand Rapids-based NxGen MDx plans to expand at its current location, 801 Broadway Ave NW Suite 203, Grand Rapids, MI 49504. The new expansion will increase the laboratory’s testing capacity and respond to increased customer demand expected to reach 300 percent over last year.

“We chose to launch NxGen in Grand Rapids back in 2014 within its prestigious medical corridor to offer our patients the very best and brightest of the genetics field,” said Kristin Sherman, Chief Financial Officer, NxGen MDx. “The expert support provided by The Right Place, combined with the collaborative resources of Grand Rapids’ Medical Mile, made the decision easy on where the next chapter of our growth would take place.”

NxGen MDx is a women’s health care organization that offers genetic screening so patients can plan their reproductive journey. NxGen offers a variety of genetic screens for inherited diseases such as Cystic Fibrosis, Spinal Muscular Atrophy, and Fragile X Syndrome. NxGen also provides best in class genetics counselors and customer service to ensure patients can easily understand their results. For more information on genetic screening and what Genetic screens NxGen offers visit www.nxgenmdx.com.

“Grand Rapids’ life sciences cluster continues to see significant growth, and NxGen is yet the latest example of that growth,” said Eric Icard, Senior Business Development Manager, The Right Place, Inc. “Companies like NxGen are not only great for our community in terms of new jobs, but they also raise national awareness of West Michigan within the industry.”

The business development team at The Right Place worked to ensure NxGen’s expansion occurred in West Michigan over a competing location in Florida. By assembling a cross-functional team of state and local resources, the team was able to work with the MEDC and City of Grand Rapids to build an aggressive business retention/expansion incentive package.

The City of Grand Rapids is supportive of NxGen’s decision to expand in the city, bringing 37 new high-tech jobs to the community. The city is considering the approval of a local PA 328 Property Tax Abatement to provide support for NxGen’s capital investment.

“This project is exciting growth for a graduate of the Grand Rapids SmartZone life science incubator. NxGen MDx began as a tenant, graduated from our incubator in 2014 and has been experiencing growth since making their location decision within the City of Grand Rapids,” said Kara Wood, City of Grand Rapids, Managing Director of Economic Development Services. “The City looks forward to the continued success of this company, as they provide good paying jobs for local talent and support the growth of Grand Rapids’ life science industry cluster.”

West Michigan’s Life Science Cluster Growth
With over $2 billion of investments along Grand Rapids’ Medical Mile and life sciences corridor, West Michigan has reached a critical mass that has made the region a destination for breakthrough healthcare, research, and medical device development and manufacturing. The industry now employs over 57,000 in the 13-county region with average earnings of nearly $65,000 per year.

West Michigan’s life sciences industry has experienced 25.9 percent employment growth over the past 10 years, compared to the national average of 15.7 percent.

About The Right Place, Inc.
The Right Place, Inc., is a regional non-profit economic development organization founded in 1985 and supported through investments from the private and public sector. Its mission is to promote economic growth in the areas of quality employment, productivity and technology in West Michigan by developing jobs through leading business retention, expansion and attraction efforts. For more information, visit: www.rightplace.org

About NxGen MDx
NxGen MDx LLC is a leading clinical molecular diagnostics laboratory delivering highly accurate and precise genetic screening to detect genetic diseases or abnormalities to help guide family planning decisions for couples and their healthcare providers. Unlike other laboratories, NxGEN MDx’s technology examines the entire gene rather than parts of the gene, giving families a comprehensive assessment of their true risk. NxGEN MDx is located in Grand Rapids, Michigan.

Two Midwest Companies Join Forces to Speed Development of Test to Identify Women at Risk for Preterm Birth

In a collaborative move to expand their diagnostic screening and testing portfolios, NxGen MDx, LLC., and NX Prenatal, Inc., announced a joint partnership to speed the development and deployment of a blood test to detect pregnancy biomarkers of preterm birth.

The partnership brings together NX Prenatal’s experience in developing exosome-associated biomarkers from maternal blood with NxGEN MDx’s comprehensive genetic screening solutions for women’s health applications.

Preterm birth affects 1 in 8 U.S. women and accounts for nearly half a million preterm births each year, costing families and insurers an estimated $26 billion. Globally, there are approximately 15 million preterm births annually, accounting for 75% of perinatal deaths. Preterm births are also a major cause of short and long-term medical complications in infants and children.

“We are excited to partner with the innovative NX Prenatal team. Our combined efforts are designed to identify which pregnant women are at risk for delivering prematurely as early as possible. NX Prenatal’s proven technology uniquely holds the potential to achieve this breakthrough,” says Alan Mack, CEO of NxGEN MDx.

Brian Brohman, Co-CEO of Nx Prenatal, concurs. “Our proprietary NeXosome Platform has the potential to identify women at risk for preterm birth as early as 10 weeks gestation — dramatically reducing the 22 weeks of current tests.”

“Clearly, our partnership aligns with our respective corporate missions. NX Prenatal’s new generation of diagnostics complements our current suite of tests that can help families and their physicians plan for healthy pregnancy outcomes,” adds Mack.

Identifying risk for preterm births earlier has a powerful ripple effect as well. “In addition to helping clinicians proactively manage those at greatest risk, patients and families will benefit from personalized care and potential tailored interventions, while payers and self-insured employers may ultimately enjoy lower claims costs related to preterm birth,” notes Gail Page, Executive Chair of NX Prenatal.

Financial terms of the transaction were not disclosed.

About NX Prenatal Inc.
NX Prenatal Inc. is a private U.S. based molecular diagnostics company located in Louisville, KY. NX Prenatal is developing diagnostic assays for adverse pregnancy outcomes and conditions such as preterm birth. The company has unlocked a new library of biomarkers for prenatal risk assessment as early as 10 weeks gestation. For more information, visit the company’s website at www.nxprenatal.com.

About NxGen MDx
NxGen MDx LLC is a leading clinical molecular diagnostics laboratory delivering highly accurate and precise genetic screening to detect genetic diseases or abnormalities to help guide family planning decisions for couples and their healthcare providers. Unlike other laboratories, NxGEN MDx’s technology examines the entire gene rather than parts of the gene, giving families a comprehensive assessment of their true risk. NxGen MDx is located in Grand Rapids, Michigan.