Recombine Files IPO Prospectus: Pioneering Personalized Reproductive Health Through Genomic Screening

Imagine a happily married couple who, after careful and repeated deliberation, solemnly decide that they want to have a child and build a complete family. Overjoyed, they prepare actively, vowing to create the most perfect and happy home for their beloved baby. However, subsequent hospital test results strike like a bolt from the blue, shattering their cherished dreams: they are not suitable for having children, as any baby born to them would suffer from severe congenital diseases.

Such scenarios are all too common. Consider the countless couples around the world preparing to welcome a new life, each facing formidable challenges. In 2011, Recombine was founded in Livingston, New Jersey, with the original mission of addressing prospective parents’ concerns before conception. By analyzing simple blood or saliva samples, the company enables comprehensive insight into potential genetic diseases in future offspring, allowing for the proactive prevention of all avoidable conditions and safeguarding the health of newborns.

Recombine is a startup in the field of bioinformatics technology. The company has published articles on its technologies, which primarily focus on diagnosing aneuploidy and monogenic disorders using gene chips. These innovations assist expectant parents in adopting new techniques—such as array comparative genomic hybridization (aCGH) or single-nucleotide polymorphism (SNP) chip technologies—to improve the health outcomes of their babies.

The article explores the development of preimplantation genetic diagnosis, highlighting that screening for chromosomal abnormalities and related genes can enhance implantation and pregnancy rates. It further points out that refining whole-genome sequencing and improving targeted single-nucleotide polymorphism analysis are effective strategies for increasing pregnancy success rates.

Gene Data Analysis Improves Neonatal Health Rates

Subsequently, the first-generation product, CarrierMap, was launched. By leveraging a network of physicians and comprehensive, efficient clinical genetic testing methods, it has provided genetic testing services to tens of thousands of parents. The company’s founders include fertility specialists, geneticists, and experts in bioinformatics and computer science, all united by a single purpose: to improve the health outcomes of newborns through feasible and reliable testing methods!

In recent years, following the completion of the Human Genome Project, the concept that genetic mutations cause diseases has been widely accepted. Rare genetic disorders are among the common and significant causes of neonatal mortality.

Traditional off-the-shelf kits can only detect a few DNA mutations and target only one disease at a time,However, Recombine’s CarrierMap technology can detect 250 genetic diseases., and more than 2,000 diseases induced by genetic coding errors,The sample requires only a small amount of the test subject's blood., it can screen for all diseases at once. Its cost is low, requiring only $500, significantly reducing the costs of the original industry.The collected samples are first sent to the company’s headquarters in New Jersey for analysis and evaluation, and then directly forwarded to the patient’s physician. The entire process takes 1 to 2 weeks.

In March 2015, Recombine announced a partnership with Sequenom Laboratories, a subsidiary of Sequenom (a leading publicly traded research company), to launch a new test named HerediT® UNIVERSAL. Leveraging Sequenom Laboratories’ non-invasive prenatal testing technology, CarrierMap expanded into new markets, integrating not only into OBGYN Project (an online medical expert community for obstetrics and gynecology) but also securing a place in the women’s fertility pharmaceutical sector.

CarrierMap (Genetic Carrier Screening Test) not only provides screening for couples with normal fertility but also offers significant convenience for in vitro fertilization (IVF) treatment.

It screens donated gametes from all ethnic groups by analyzing parental family histories or genetic predispositions to hereditary diseases, thereby preventing genetic disorders in newborns. This holds significant social importance for the multi-ethnic, genetically diverse population of the United States.

Specifically, its applications include:

1. Egg Donor Screening: All eggs are donated by young donors, resulting in relatively higher conception and fertility rates. This testing primarily targets genetic disorders and X-linked conditions, significantly reducing costs compared to traditional screening methods through Recombine’s platform.
2. Parental Screening for Gamete Acceptance: For prospective parents undergoing in vitro fertilization (IVF), undergoing testing can also reduce the likelihood of transmitting genetic diseases to their offspring.
3. When a mutated gene is detected: Whether in the donor or the recipient, the detection of a mutation implies that the embryo may also carry the disease-causing gene; therefore, rigorous screening and transplantation of healthy embryos are essential. In such cases, what should be done? Recombine recommends Global Genes, an organization that has convened expert panels to provide couples with various strategies, offering comprehensive explanations of genetic diseases, associated challenges, and available resources.

Cyprus IVF clinics also adopt Recombine’s technology, strictly mandating screening tests for gamete donors in accordance with European standards. They also consider the donor’s place of birth to exclude risks of region-specific diseases.

In the past, it was technically impossible to identify genetic diseases; however, with the advent of Recombine testing, this has become possible. A simple blood test can now analyze potential hidden disease risks in donors that were previously unknown.

In 2015, Recombine also launched a testing service called ChromoMap, which enables non-invasive screening to analyze the chromosomal health of the fetus. This service is designed for pregnant individuals, utilizing genetic analysis to assess pregnancy-related risks and thereby reduce potential complications during pregnancy.

Personalized Diagnosis of Infertility

In addition to CarrierMap, Recombine has also developed FertilityMap, a genetic testing and assessment technology for evaluating women’s ability to conceive healthily.

When a woman is pregnant, the factors that typically influence a healthy pregnancy include the following: Are the reproductive organs of both partners normal? Can the sperm reach the egg? Is the wife’s menstruation regular? Once conception is successful, will the fetus receive adequate nutrition? Only when all these questions can be answered affirmatively before pregnancy will the expectant mother feel confident about childbirth; otherwise, she may feel apprehensive and hesitant to proceed.

In fact, each of the aforementioned individual issues involves the participation of numerous regulatory genes in the body. The physiological processes governed by gene regulation determine whether the ultimate outcomes are favorable or unfavorable. While the overall regulatory mechanisms are consistent across humans, individual genetic variations contribute to each person’s uniqueness. Naturally, such genetic differences can also be detrimental, leading to adverse outcomes.

For many years, the phenomenon of infertility has deeply troubled physicians and scientific researchers. They have found that numerous genetic variations in individuals can lead to difficulties in conceiving. It is certain that every physiological process is regulated by multiple genes, and the inability of a couple to conceive may be attributed to abnormalities in multiple genes.

Recombine seeks to unravel this mystery by conducting in-depth research to understand how various genetic combinations and interactions influence fertility. Its first product in the fertility sector, FertilityMap, analyzes hundreds to thousands of fertility-related genes to identify genetic combinations associated with infertility. By discovering and summarizing these patterns, the tool assists physicians in treating infertile patients and improving their chances of conception.

Like other companies, Recombine also adopts Illumina sequencing technology (for more details about Illumina, please read:Is Illumina Smarter Than Google?), butThe company’s proprietary software undoubtedly sets it apart.. Founder Bisignano positioned it this way: “We are a lean-startup tech company with an agile entrepreneurial team.”Agility is particularly crucial for genetic testing R&D companies., in this era of information overload, many diseases have become hotly contested subjects of research. As the cost of genetic testing continues to decline, competition within the industry is bound to intensify further; in a race against time,Recombine aims to minimize the time required from physicians and has developed numerous software solutions to provide result counseling for every couple.

Young Startup Team

Who would have thought that the co-founder behind such a successful biotechnology company is a mere 27-year-old young man? His name is Alexander Bisignano, a biology graduate from Princeton University who previously worked at Credit Suisse in the financial industry. He is also the developer of the company’s genetic testing software.

Another co-founder, Dr. Santiago Munné, is a pioneer who first developed preimplantation genetic diagnosis (PGD) technology in the 1990s; he founded Reprogenetics, the largest PGD genetics laboratory in the United States.

Other co-founders include Kelly Ketterson, an embryology specialist who worked at the Reprogenetics laboratory and was responsible for building the ambitious fertility gene network. Jill Fischer and Dagan Wells are also among the founders.

Turning to the company’s employees, they are characterized by diversity. Each individual brings unique strengths and distinct personalities. It is precisely this group of individuals, with their widely varying personalities, backgrounds, interests, and areas of expertise, that constitutes Recombine as it stands today. Team spirit enables everyone to leverage their specialized skills, produce the highest-quality products, and continuously improve service standards.

Recombine Continues to Expand Its Market Presence

In fact, Recombine is not the only ultra-low-cost sequencing company born from the perfect integration of computer science and big data; Counsyl, a Silicon Valley-based firm, is one of its formidable competitors. Counsyl tests 4% of all newborns in the United States each year, with annual operating capital exceeding $80 million.

But Recombine’s ambitions appear to extend further. In addition to typical genetic screening, the company also screens for recessive genes inherited from parents to identify a broader range of genetic disorders. Leveraging its strong capabilities in gene sequencing, Recombine goes beyond simple genomic sequencing or monogenic disorders to further elucidate how 60 genes interact with one another.

In August 2013, the company became profitable, with annual revenue reaching $3.5 million. Meanwhile, it actively collaborated with other platforms to continuously expand its business scope. For instance, in February of this year, it jointly launched offline genetic screening services with New York Fertility Services.

As evident from the advertising campaign, couples can obtain a suite of high-value genetic testing services for just $95. These services include multi-panel prenatal screening, CarrierMap carrier screening, a face-to-face consultation with expert Joel Batzofin, and counseling sessions with Recombine’s certified specialists. Undoubtedly, the high demand for these consultations has generated significant brand buzz among the public, further expanding the company’s influence.

In 2012, Recombine secured $450,000 in investment. In March 2014, the company raised $3.3 million in Series A financing led by FirstMark Capital, with participation from prominent New York tech founders Nat Turner and Zach Weinberg, Alex St. Amand of the Gerson Lehrman Group, Vast Ventures, and Vivek Garipalli, among others.

In light of the news that the FDA has ordered genetic testing company 23andMe to halt sales of its products to consumers, Recombine has stated that it holds medical certifications and has obtained approval from the New York State Department of Health. Therefore, it will not repeat the same mistake and will proceed cautiously by selling its products exclusively directly to physicians.

Matt Turck, an investor at FirstMark, also believes that Recombine has the capability to fully master big data technology, empowering people to explore and understand the mysteries within their own genomes. The company’s initial large-scale R&D initiatives have already received approval from the ethics committee, and it has assembled a team of top-tier data scientists in New York.

Recently, it has partnered with The Muse, a startup website focused on cancer, aiming to expand into the new field of oncology. The new application will predict whether patients will develop resistance to cancer treatments, while also investigating complex fertility issues such as recurrent miscarriage.

We believe that Recombine’s future will be even brighter.

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