The Science and Diagnostic Services Inside Molecular Testing Labs

We design our lab to be different from the beginning. Forget the restriction of your traditional lab – if you can dream it, we can make it happen.

Our Labs

Our CLIA-certified and CAP-accredited lab meets rigorous quality standards, including qualifications for individuals who perform the test and other standards that ensure the accuracy and reliability of results. See our Compliance and Ethics program here.

Molecular Testing Labs is a state-of-the-art, esoteric laboratory. We specialize in high-complexity molecular testing with an extensive portfolio of services, including infectious disease, toxicology, targeted sequencing, single-nucleotide polymorphism (SNP) genotyping, and high-resolution immune profiling. Our lab offers a variety of clinical trial services composed of assay development, trial site training, investigator support, and customized reporting.

We apply the maximum level of control to obtain the most consistent and highest-quality results. Molecular Testing Labs is founded on the guiding principles of compliance, innovation, partnership, integrity, agility, and unity.

Molecular Testing Labs
Molecular Testing Labs

View the 70+ tests the Molecular Testing Labs can process for clinics, digital health companies, public health departments, and research universities. Our clinical laboratory uses a variety of techniques, not limited to LC-MS/MS, ELISA, NAAT, and real-time PCR, to obtain the most reliable result, improving patient care and better outcomes. See the full testing menu below or contact us for your customized testing needs.

TESTING MENU

Clinical Chemistry Lab

The latest addition to Molecular Testing Labs, the Clinical Chemistry laboratory provides routine and state-of-the-art specialized assays to support patient care. The Clinical Chemistry lab specializes in the measurement of analytes associated with specific health conditions, allowing patients to identify and address serious concerns early on and ultimately improve their quality of life. Current test offerings include:

  • Fecal occult blood (iFOB), which is a latex agglutination test used to screen for colorectal cancer.
  • A panel of antibodies associated with rheumatoid arthritis, a debilitating condition that – if left untreated – leads to chronic joint pain.
  • Anti-Mullerian hormone (AMH), which is associated with fertility and disorders such as polycystic ovarian syndrome (PCOS).
  • Antibodies associated with celiac disease, which causes inflammation that damages the villi of the small intestine and inhibits the body’s ability to absorb nutrients.
  • A panel of hormones indicating poor thyroid function, which affects a variety of metabolic processes.
  • Antibodies associated with Lyme Disease, an infection that develops after exposure to a tick-transmitted bacterium.

Genomics Labs

Our Molecular Genetics Lab is empowering patients to take control of their healthcare by individualizing it based on their unique genetic code. Through our pharmacogenetic (PGx) panels, we help patients, in partnership with their doctors, find personal recommendations for correct dosing of therapeutic drugs that are tailored to that person’s genome and response to those drugs. Our clinical lab uses real-time PCR to obtain the most reliable result.

We are using this same technology to provide recommendations, not only for healthcare but also the best way to remain healthy through FITNESS testing. This is through an alliance with IDLife where you can collect a sample from the comfort of your own home and receive a personalized booklet with suggestions for healthy living. Contained in this 43-page report are results tailored to help you determine the best way to work out and lose weight while avoiding injury and recovering better. Tailored appetite control methods and vitamin recommendations are also provided for healthy living and making the best YOU!

Not only are we empowering individualized healthcare for everyone, but we are also working with clinicians to provide the best-recommended therapy for urinary tract infections. We are challenging the overuse of antibiotics by identifying the exact pathogen(s) infecting a patient and examining which drugs will work best if those pathogens have developed resistance to the “usual” antibiotic by identifying antibiotic resistance in real time. In addition, we utilize our RNA lab and expertise in real-time PCR to run our innovative hepatitis C viral load dried blood spot assay.

Infectious Disease Lab

Our Infectious Disease Lab is a state-of-the-art, fully automated, high-throughput lab. The laboratory specializes in diagnostic testing for sexually transmitted infections (STIs) and respiratory pathogens. The Infectious Disease lab has several “firsts” to its credit – it was the first lab in the country to offer a comprehensive, at-home self-collected STI panel. It was the first to offer human papillomavirus (HPV) screening for males from urine samples. The lab is also the only one in the country to develop hepatitis C viral load testing from dried blood spots. It was the first to offer comprehensive PrEP testing panels for at-home collection.

The Infectious Disease laboratory offers dried blood spot ELISA testing for SARS-CoV-2**, hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), herpes simplex virus type II, and syphilis. Other STIs include chlamydia, gonorrhea, trichomonas, mycoplasma genitalium, and human papillomavirus. Chlamydia, gonorrhea, and HPV can be performed on genital, oral, or rectal collections. Respiratory pathogens include SARS-CoV-2*, Flu A/B, RSV, adenovirus, human metapneumovirus, parainfluenza, and common coronavirus.

*This product has not been FDA-cleared or -approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. We do not perform testing on COVID samples collected at home.

**This product has not been FDA-cleared or -approved and is only available for research use.

Toxicology Lab

Our Founding toxicology and chemical analysis laboratory for comprehensive quantitative and qualitative testing of urine and saliva clinical specimens. Testing can be performed to detect any kind of illicit substance in both recreational and prescription drugs. Toxicology testing is used by employers for on-the-job substance screening, clinicians for treatment diagnosis and tracking, and pathologists and medical examiners for forensic toxicology identification.

Our Toxicology Laboratory also provides a plethora of esoteric testing options in addition to the industry-compliant illicit drugs and pain management testing panels. Clients/physicians are notified on any consistencies or inconsistencies of drug testing results compared to drugs prescribed. Molecular Testing Labs utilizes highly efficient, state-of-the-art instrumentation that yields quantitative and qualitative results.

The vision of Molecular Testing Labs is to provide toxicology testing to all demographics within communities, including those who do not have access to healthcare.

BioLibrary

Molecular Testing Labs’ BioLibrary (BL) is devoted to progression. Samples are collected, catalogued, de-identified, and stored in the proper environment to maintain stability of the sample. Adherence to de-identifying is crucial, and it is done according to the Safe Harbor method of the Health Insurance Portability and Accountability Act (HIPAA) to protect patient identities when providing samples. The purpose of retaining these rare samples is to assist in further understanding diseases and strive to advance diagnostic treatment of diseases. These stored samples can be used for development of the next clinical studies within Molecular’s Research and Development department and primarily for use by third-party research institutions. To obtain a list of samples or for questions, please email BioLibrary@moleculartestinglabs.com.

Our Services

Our CAP-accredited and CLIA-certified high-complexity laboratory provides accessible and innovative laboratory solutions through collaborative partnerships with payors, private healthcare institutions, universities, and public health organizations.

Research & Development

Pushing the boundaries of patient access requires a steadfast commitment to novel science. We allow our partners to dream so that we can make those diagnostics dreams a reality. From research universities to pharmaceutical manufacturers, our Research & Development team makes the improbable possible.

Logistics

Transforming diagnostic paradigms means considering the entire patient-provider journey. From devices for clinical collection to complete kits for patient collection and custom kits, we offer a complete logistics stack to maximize project outcomes. Our clients rely on us to keep their healthcare service needs moving forward, regardless of where their patients live.

Diagnostics

The heart of everything we do is about delivering actionable results to patients and their healthcare provider. We design our diagnostic capabilities to maximize patient access and outcomes, whether it’s non-clinical collection to increase who can be tested or pharmacogenetics to determine which medications will be most effective.

People, Processes & Technology

Our team is made up of mission-driven innovators, forward-thinkers, and skilled collaborators in an ecosystem of learning and growth. They integrate continuous improvement processes and lean methodologies throughout the company in alignment with our strategic business objectives, as well as leverage various technologies to support and automate the systems necessary to lift up our customers. Data is at the core of every single project we embark on, and our customer Laboratory Information System (LIS) enables clients of all sizes to submit orders and retrieve results, including states monitoring infectious diseases and researchers seeking to understand patient behavior.

Credentials

We are a high-complexity CAP-accredited and CLIA-certified diagnostic laboratory. Molecular Testing Labs is in full compliance with the Health Insurance Portability and Accountability Act.

Molecular Testing Labs reinforces the following:
Molecular Testing Labs is a CMS-designated “covered entity” sworn to uphold all HIPAA considerations.
All employees, contractors, and agents of the lab must complete annual compliance training.
All providers must be registered with Molecular Testing Labs.
Physician and patient signatures of consent are mandatory on all tests.
Use of encryption is required on applicable communications.
Laboratory Information System access is protected per HIPAA guidelines.

CAP Accredited
HIPAA

Interested in partnering with Molecular Testing Labs?

Let us Empower you.