Predicta Biosciences and Droplet Biosciences, two companies in Residency at The Engine, are working on game-changing diagnostic technologies with the potential to transform outcomes for cancer patients.
For their part, Predicta’s diagnostics platform enables invasive bone marrow biopsies to be replaced with a simple blood draw, unlocking unprecedented insights to guide precision cancer therapies. Meanwhile, Droplet’s novel platform for harvesting and profiling lymphatic fluid, collected via surgical drains, enables doctors to evaluate the risk of disease recurrence immediately after removing a tumor.
For biotech startups like Predicta and Droplet, the transition from breakthrough research to commercial diagnostics represents a critical inflection point — the moment when promising science begins serving real patients. However, this transition is not possible unless startups meet complex regulatory requirements, most notably securing CLIA (Clinical Laboratory Improvement Amendments) certification.
To help residents navigate this process, The Engine partnered with South Shore Lab Consultants (SSLC), a local organization with extensive experience supporting the regulatory needs of early-stage biotech companies. By engaging with SSLC, Predicta and Droplet were able to obtain their CLIA certification within months, accelerating their path to impacting patient lives.
The South Shore Laboratory Consultants team provides comprehensive support to help biotech startups navigate complex regulatory requirements, including CLIA certification.
The CLIA Challenge
CLIA certification is a federal requirement that allows laboratories to accept patient samples from physicians. Essentially, for any biotech company that wants to put their innovative research into practice and diagnose patients or guide patient treatment decisions — they need CLIA. In addition to the federal certification, Massachusetts requires laboratories to apply for a MA State Clinical Laboratory License. There are an additional six states that also require diagnostic labs to obtain out-of-state clinical laboratory licenses to serve patients across the United States.
These certifications demand rigorous quality and safety standards, comprehensive quality management systems (QMS), and strict compliance protocols. For early-stage companies, with small teams and limited resources, these requirements can be overwhelming, and a significant hurdle in the way of creating a sustainable business that can impact patient lives.
Startups must navigate three to four different sets of regulations, deciphering convoluted legal writing to create compliant policies. Any personnel performing tests and supervising labs must meet stringent qualification requirements, while facilities must also meet many safety and environmental control requirements.
A Better Model for Startup Compliance
Many assume that shared laboratory spaces, like those at The Engine, cannot accommodate CLIA-certified operations due to HIPAA concerns, but The Engine's partnership with SSLC proves otherwise. In fact, resident companies that contract with SSLC in The Engine’s shared lab space gain unique advantages that significantly lower the barriers to CLIA certification through our collaborative model.
Cost Efficiency: Operating in a shared space eliminates significant overhead costs that would otherwise burden individual startups. Companies benefit from shared equipment that The Engine owns and supports with annual maintenance programs. These expenses can be prohibitive for early-stage companies to shoulder independently.
Regulatory Expertise: SSLC brings deep regulatory knowledge and established relationships with the Massachusetts Department of Public Health and other agencies. Their standardized processes, refined through work with numerous startups, accelerate timelines and help startups efficiently navigate the regulatory landscape.
Comprehensive Support: The Engine maintains equipment to ensure companies can sustain their CLIA certification. We also provide the specialized infrastructure required for CLIA compliance, including precise environmental controls and documentation systems. SSLC also provides on-going support to ensure that compliance is maintained at all times.
Accelerated Implementation: SSLC's 50-70 pre-written policy templates allow companies to avoid the months-long process of developing compliance frameworks from scratch. This standardized approach, combined with SSLC's years of experience and ability to efficiently set up all CLIA lab processes, enables most startups to achieve CLIA certification within six to twelve months.
The Droplet team at work in their private lab suite at The Engine.
Accelerating the Path to Impact
Both Predicta and Droplet achieved CLIA certification within six to eight months of beginning the process — a timeline that positions them to begin serving patients and generating revenue more quickly than would be possible in traditional laboratory setups.
"The Engine and SSLC were instrumental in facilitating our path to CLIA certification," said Danielle Sookiasian, Principal Scientist at Predicta. "Obtaining CLIA certification as rapidly as possible was key to enabling the launch of Predicta's first clinical test, and this would not have been possible without leveraging The Engine's infrastructure and SSLC's regulatory expertise."
Xiaomin Zhao, Director of Clinical Testing at Droplet, echoed this sentiment: "SSLC's hands-on approach and The Engine's compliant shared space allowed us to navigate the regulatory maze efficiently. Their support helped us to complete the certification process and be ready to accept patient samples in under eight months, which would have been a challenge to accomplish on our own."
With their CLIA and state certifications in place, Droplet and Predicta can begin impacting patient outcomes and generating revenue, accepting samples from physicians across most of the country. For the few states that require additional licensing, SSLC will assist the teams in obtaining these licenses as well. From here, the companies could pursue CAP (College of American Pathologists) accreditation with support from SSLC, which demonstrates enhanced quality standards valued by the market, though this typically requires an additional year.
The Predicta team is developing their first clinical test in their shared lab space at The Engine.
The support doesn’t end when companies receive their CLIA certification. SSLC continues to support certified companies with quarterly on-site audits, acting as external inspectors to review records and ensure continued compliance with policies and procedures. This proactive approach helps companies maintain their certifications while focusing on growth and product development.
The Engine and SSLC’s collaborative model demonstrates that shared laboratory spaces can successfully accommodate the complex regulatory requirements of clinical diagnostics. By combining specialized infrastructure, regulatory expertise, and cost-efficient operations, we enable biotech startups to transition from research to patient care more rapidly and affordably than the alternative.
For the many resident companies working toward clinical applications, this partnership provides a clear pathway from promising research to meaningful patient impact. In a sector where time-to-market and capital efficiency are critical to long-term success, The Engine's partnership with SSLC represents a competitive advantage that can accelerate the journey from the laboratory bench to the patient journey, unlocking new hope for millions of patients.
