Lab 21 becomes Cambridge Clinical Laboratories and pledges to offer revolutionary diagnostic tests
A pathology services laboratory relaunched under new ownership has pledged to give clinicians access to revolutionary diagnostic tests.
Cambridge Clinical Laboratories is the new name for Lab 21, the Milton-based business launched in 2005 which has been acquired from Novacyt Group by Cambridge Pathology BV.
It performs oncology and virology diagnostics for the NHS and private healthcare providers and aims to expand next year to offer services in areas such as autoimmune disesases, gastric conditions and sexual health.
Returning to run the business as CEO is Dr Anthony Cooke, who was Lab 21’s first employee and worked there until 2013, when family circumstances prompted him to set up a consultancy business focused on regulatory affairs for diagnostics.
“The objective of Lab21 was to bring in state-of-the-art diagnostics and it’s exactly the same now, but we’re going to try and do it for a much wider range of diseases and geographically operate in more territories. With the help of our investors we are looking at locations in Europe and the Far East,” Tony tells the Cambridge Independent.
“What we want to do is carry on what was started in 2005 but build it so we are seen as the premiere clinical testing lab for state-of-the-art diagnostics in the UK.”
Accredited by UKAS to the ISO 15189 standard for medical laboratories, Cambridge Clinical Laboratories focuses on “high-value, low-volume state-of-the-art tests”, since routine tests are carried in the NHS’ own pathology labs.
“The NHS is one of our biggest customers – and one of our biggest competitors,” says Tony.
“One of the tests we offer is therapeutic drug monitoring for HIV treatments. It monitors whether the drug is still effective in your blood against the virus.
“And we were one of the first companies to offer tests such as KRAS and BRAF for tumour identification. With a lot of tumours, a certain mutational state has to be identified before a drug can be prescribed, and we do that sort of testing.”
Cambridge Clinical Laboratories expects its work with pharmaceutical companies to provide these kind of companion diagnostics to grow in the age of personalised medicine.
And Tony is keen to offer “revolutionary” tests using breakthrough technologies from medtech and diagnostic companies around the world.
“We have a test from a company in America, MdXHealth, called SelectMDX. It is a genetic test for prostate cancer that is widely used in America and Europe and we’re trying to get it adopted over here,” says Tony.
The test analyses tumour cells from a urine sample to identify a patient’s prostate cancer risk, and the likelihood of it being a high grade disease. This can help reduce unnecessary needle biopsies, which can have significant side effects for men.
“These types of test revolutionise diagnosis and treatment,” notes Tony. “Prostate cancer is a very poorly diagnosed disease in my opinion. There is no prostate cancer screening programme in the UK.”
Many of the cutting-edge tests offered by the laboratory are CE-marked and approved by the US Food and Drug Administration (FDA).
“One I’m looking at for colo-rectal cancer has been available in the United States for three years. I can get it in Germany and France. I’ve been asked for it by a number of consultants.
“We are an early adopter because we are independent,” says Tony. “The NHS does an amazing job. But it doesn’t have the capability as a huge organisation. It is slow to adopt or change. It doesn’t have that agility.
“Diagnostics and therapeutics can also be expensive. One test we’ll be running next year looks for 17 biomarkers. It’s really complex and takes four-and-a-half hours, and more and more people are requiring them.”
The business offers a simple price list for its tests, which range from tens of pounds to hundreds.
Sometimes new equipment is required to adopt a test, so the laboratory makes a commercial decision of its viability before taking it on. It must then prove it can perform the test accurately.
“We have to do EQA panels on every test, which means we are judged by our peers to see whether we can run those tests. The results are published,” says Tony.
Annual audits enable it to add tests offered under its accreditation.
“We use a variety of technology. We have our own capabilities in the lab – PCR work and sequencing, and we also have access to other sister laboratories, which are fully accredited,” he says.
“Non-invasive or minimally invasive diagnostics are the way forward. If you can do it by imaging, or by blood, urine, sweat or saliva, these are much better than a biopsy.”
Tony reflects on the huge progress made in healthcare – and believes diagnostics, some of them created in Cambridge, will play a key role in ongoing advances.
“My parents’ generation had polio and rickets and all the childhood diseases. In my generation, the vaccinations started coming through.
“Now we’re into genomics and gene therapies. Genomic screening services are key for the future. We’ve got to get to a position where we are preventing disease rather than treating disease,” he says.
“When you look at genetic diseases, pre-screening and pre-natal testing would improve our health. It’s radical but if you took a sample from a newborn and sequenced its whole genome, you could predict where the risk areas were.
“If your genetics show you may have a predisposition towards certain things, you might modify your lifestyle.”
In the longer-term, he anticipates that whole body MRI scans – “a bit Star Trek”, he acknowledges – could be used by clinicians, potentially in tandem with artificial intelligence to identify potential problems.
As our ability to diagnose disease earlier and target specific treatments improves, Cambridge Clinical Laboratories is poised for growth.
With its new investment, it expects to expand its team of eight – and grow its offer significantly in the age of personalised medicine.