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Rapid Expansion of Direct to Consumer Laboratory Testing

Direct-to-consumer laboratory testing is increasing as individuals become more educated and proactive about their health care. Direct to consumer laboratories include both traditional clinical laboratories and new genomic laboratories. Kalorama Information projects that the market will exceed $350 million by 2020.

The January 20, 2016 issue of MedCity News (http://goo.gl/Stfphs) contained a nice summary of 20 major players which are listed below.

23andMe provides genetic analysis to consumers including ancestry, physical characteristics and carrier screening. 

Any Lab Test Now is a franchise of 150 laboratories offering tests for paternity, STDs, drugs, allergies and diabetes management.

Color Genomics sells Color Kits for $249 that analyze 19 genes  using next generation sequencing to assess the risk of developing ovarian and breast cancer.

Counsyl provides testing for inherited diseases and focuses on ruling out carrier status for parents who are contemplating pregnancy.

Direct Laboratory Services offers wellness screening, as well as laboratory tests for arthritis, autism, cancer and a number of other diseases by partnering with Quest Diagnostics.

Gene by Gene offers carrier screening, whole genome sequencing, mitochondrial DNA sequencing, and family tree analysis. 

HealthCheckUSA is a discount direct-to-consumer testing lab based in Minnesota that offers standard clinical laboratory tests

Home Access Health advertises the ability to perform multiple laboratory tests on a few drops of self-collected blood.

Laboratory Corp.announced in 2015 that it would allow customers to order lab tests online without a doctor’s order.

MyMedLab was one of the first labs that performed laboratory tests without a physican’s order. It offers general health testing, metabolic panels, and female and male health screens.

Mapmygenome is based in India and provides screening for genetic traits, drug response and inherited diseases.

Pathway Genomics offers a liquid biopsy to detect cancer as well as pharmacogenomics and hereditary cancer carrier screening.

Positive Bioscience is based in India and offers personal genomic screening for predisposition to cancers of the breast, pancreas, ovaries, endometrium, skin, prostate, colon, lung and GI tract.

Quest Diagnostics offers a Blueprint for Wellness Direct Pay system for consumers that can be ordered online, without a doctor’s order.

Request A Test is an Ohio-based company that offers 59 test panels for sexually transmitted disease, celiac disease, heart disease and immune disorders.

Sonora Quest Labs in Arizona offers My Lab ReQuest, which offers direct-to-consumer wellness testing. It also has partnered with Safeway grocery stores to open retail diagnostics centers.

Theranos used to be a much discussed player in this market but has ceased operations after receiving a cease and desist order from the FDA.

Walk-in Lab is a Louisiana-based traditional diagnostics company that partners with LabCorp to offer heart health screening, cancer screening, wellness tests, STD testing, hormonal panels and more.

WellnessFX focuses on preventative care by testing for biomarkers that assess cardiovascular, metabolic, hormonal and nutritional health issues.

Xcode Life Sciences is an India-based laboratory that provides pharmacogenomic testing and wellness evaluations.

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