#USA #New York #semen analysis #Legacy Fertility #DNA Fragmentation

Legacy Receives New York State Approval for Fertility Tests

Legacy, a top male fertility testing and sperm preservation company, has achieved a significant milestone by receiving approval from the New York State Department of Health for two of its core laboratory-developed tests: semen analysis and DNA fragmentation analysis. This accreditation, administered under New York's Clinical Laboratory Evaluation Program (CLEP), signifies that both tests have cleared one of the most stringent pre-market reviews in the country, validating their methodologies and clinical efficacy.

New York is unique in its rigorous requirements, mandating that all laboratory-developed tests (LDTs) undergo formal pre-market evaluation, unlike the more common federal standards that primarily focus on laboratory operations themselves. This state-level scrutiny encompasses the assessment of the tests’ actual methodologies, making it one of the toughest approval processes available. As such, New York's standards are recognized as being even more stringent than those imposed by the federal Centers for Medicare & Medicaid Services (CMS).

The Importance of the Approved Tests

Both of Legacy's approved tests utilize computer-assisted sperm analysis (CASA) technology and can be performed on samples collected by patients at the comfort of their homes. The semen analysis aims to provide a clinical evaluation of key sperm parameters, while the DNA fragmentation test assesses the integrity of the genetic material found in sperm. This latter measurement has become increasingly essential in evaluating male fertility—offering a comprehensive understanding for patients and healthcare providers alike.

Dr. Scott Lundy, the Chief Medical Officer at Legacy, expressed that obtaining certifications for these tests underscores their dedication to clinical excellence. With these approvals, patients and their physicians in New York can have confidence in the accuracy and reliability of results derived from these tests, which are comparable to gold-standard evaluations. He emphasized that this certification not only reinforces Legacy's commitment to the male reproductive health sector but also facilitates better access to crucial fertility evaluations.

Khaled Kteily, founder and CEO of Legacy, also commented on the significance of this achievement. He noted that New York sets the highest benchmarks for laboratory testing among all states in the country, saying, "Having both our semen analysis and DNA fragmentation tests approved means that New Yorkers can now receive clinical-grade assessments without leaving their homes, trusting that these tests have met the most thorough standards available. This has been the goal that we have been striving toward for years."

About Legacy

Legacy operates as a leading male fertility clinic within the United States. Its services include home semen analysis, sperm cryopreservation, and post-vasectomy testing. With a CLIA-certified, high-complexity andrology laboratory, Legacy leverages one of the largest proprietary datasets in the field of male reproductive health. As part of its mission, the clinic aims to advance accessibility, data, and innovation in fertility care.

Important Information

It’s worth noting that Legacy's semen analysis and DNA fragmentation tests are specifically laboratory-developed tests approved by the New York State Department of Health for use on specimens collected within the state. While this approval pertains to the tests themselves, it does not extend to the specimen collection devices or any artificial intelligence technologies used in conjunction with the tests. Patient reports will include details regarding the limitations of the assays.

Conclusion

Legacy's achievement in securing New York State CLEP approval for its semen analysis and DNA fragmentation tests marks a pivotal moment in enhancing patient access to reliable and accurate fertility assessments. As more men seek solutions for fertility issues, Legacy is poised to play a crucial role in delivering essential health information directly to them through at-home testing capabilities.